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Did you know that glaucoma is the second leading cause of blindness worldwide?1 If you or a loved one have been diagnosed with this debilitating disease, you're probably aware of the need for consistent eye care and attention to your disease management plan.

However, due to the COVID-19 pandemic, most non-emergency doctor visits and in-patient procedures have been cancelled or postponed to reduce the risk of spreading the virus among patients and health care providers. Consequently, most ophthalmology practices are either closed or continuing to treat patients only remotely.

But those pandemic-related precautions do not mean suspending care for your glaucoma. It’s especially important to be aware of the disease’s warning signs and to seek medical help when you need it. Even if you have to stay at home, your ophthalmologist may be able to treat you through an online telehealth session, or perhaps over the phone.

Warning signs

If you’re currently being treated for glaucoma, call your doctor right away if you:

  • Notice changes in your vision (like blurry, wavy or blank spots)
  • See a lot of new floaters or flashes in your field of vision
  • Suddenly lose some vision
  • Have eye pain, headache, red eye, nausea and/or vomiting

The American Academy of Ophthalmology also recommends taking extra precautions during the COVID-19 situation, as the virus can spread through the eyes:2

  • Avoid the urge to rub your eyes
  • Adjust your glasses using a tissue instead of your fingers
  • Before administering eye medicine, wash your hands with soap and water at least 20 seconds, and wash them again after using eye drops. Be careful not to let the medicine dropper touch your eyes or face.

The good news is that telemedicine has already reduced the need for in-person visits for many aspects of eye care. And the field of teleophthalmology continues to innovate through the creation of advanced apps and take-home devices, including virtual reality tools. Ophthalmologists are already starting to use these new technologies to help diagnose, assess and monitor serious eye conditions such as glaucoma and ocular hypertension.3

Treatment options

Telemedicine visits can also allow your ophthalmologist to monitor your condition remotely and even prescribe medications to treat your glaucoma.

One of the most recently available treatments is XELPROS™ (latanoprost ophthalmic emulsion) 0.005%, which is the only FDA-approved benzalkonium chloride-free ("BAK-free") formulation of latanaprost – a commonly used glaucoma medication. XELPROS has been shown to reduce intraocular pressure (IOP, or pressure inside the eye), which is often elevated in people with open-angle glaucoma or ocular hypertension. Xelpros delivers latanaprost with LIPIXELLE™, a novel micelle microemulsion formulation to help optimize absorption [see important safety information below].

"Benzalkonium chloride, or 'BAK,' is a common preservative in several glaucoma treatments, and can induce or exacerbate adverse reactions in certain patients," said I. Paul Singh, MD, President of The Eye Centers of Racine and Kenosha. "Those reactions can include eye redness, dry eye, loss of ocular surface glands, and other issues. The availability of a BAK-free glaucoma treatment is therefore a real benefit for many patients."

Another advantage of XELPROS is that it's easy to obtain this medication remotely using the XELPROS Xpress™ program. If you have a prescription, XELPROS Xpress makes sure you will get exactly the medication you were prescribed, and not some other product. XELPROS Xpress also allows your health care provider to write your prescription without obtaining any prior authorizations. Once you have your prescription, you can order a 1- to 3-month supply ahead of time, ensuring that you won't have any interruption of your treatment. What’s more, ordering a 3-month supply makes you eligible for a discount.

"Right now, when we need patients to avoid the risk of in-office visits and trips to the pharmacy, XELPROS Xpress is very convenient," adds Dr. Singh. "With much of the population staying at home, it's crucial for eye care professionals to be able to treat patients remotely not only to help protect their eye health, but also their overall health."

For more information about XELPROS and XELPROS Xpress, contact your eye doctor or visit www.xelpros.com.


INDICATIONS AND USAGE

XELPROS is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.


IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS

XELPROS is contraindicated in patients with known hypersensitivity to latanoprost, or any other ingredients in this product.

WARNINGS AND PRECAUTIONS

Pigmentation: XELPROS may cause changes to pigmented tissues. The most frequently reported changes are increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as XELPROS is administered. After discontinuation of XELPROS iris pigmentation is likely to be permanent. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known.

Eyelash Changes: XELPROS may gradually cause changes to eyelashes, vellus hair in the treated eye including increased length, thickness, pigmentation and number of lashes. The changes are usually reversible upon discontinuation of treatment.

Intraocular Inflammation: XELPROS should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.

Macular Edema: XELPROS should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Herpetic Keratitis: XELPROS should be used with caution in patients with a history of herpetic keratitis. XELPROS should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated.

Bacterial Keratitis: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.

Use with Contact Lens: Contact lenses should be removed prior to administration of XELPROS and may be reinserted 15 minutes following administration.


ADVERSE REACTIONS

The most common ocular adverse reactions reported in clinical trials (incidence ≥5%) for XELPROS were eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening.


DRUG INTERACTIONS

Precipitation may occur if drugs containing thimerosal are used concomitantly with XELPROS. If such drugs are used, they should be administered at least five (5) minutes apart.

Please click here for Full Prescribing Information.

[1] Biggerstaff KS. Primary open-angle glaucoma (POAG). Medscape, 2018. https://emedicine.medscape.com/article/1206147-overview#a6. Accessed September 5, 2018.

[2] Mukamal R. Coronavirus eye safety. American Academy of Ophthalmology, EyeSmart, March 20, 2020. https://www.aao.org/eye-health/tips-prevention/coronavirus-covid19-eye-infection-pinkeye. Accessed April 20, 2020.

[3] Misra P, Al-Aswad LA. Diagnosing and monitoring glaucoma with teleophthalmology. Glaucoma Today, March/April 2019. https://glaucomatoday.com/articles/2019-mar-apr/diagnosing-and-monitoringglaucoma-with-teleophthalmology. Accessed April 20, 2020.

With the COVID-19 pandemic altering our daily lives, it's especially important to take care of yourself -- and not to overlook other health conditions you may be living with. That's particularly true of dry eye disease, an inflammatory condition that affects more than 16 million people in the U.S., and which can mimic or be exacerbated by seasonal allergy symptoms. If you’re one of those people and you’re venturing outside, the bright sunlight and invisible molecules in the air – mold, pollen and dust – can aggravate your dry eyes. Staying indoors can also be tricky, given the prevalence of household dust and allergens and the stress on your eyes from excessive screen time. What can you do to get relief?

"People with consistent dry eye should speak with their eye care professional about the problem," says Dr. Barry Lee, a corneal specialist and ophthalmologist with Eye Consultants of Atlanta. "A diagnosis of dry eye disease means you do not have enough quality tears to lubricate and nourish the eye. This condition occurs for a variety of reasons, including age, gender, medications, medical and environmental conditions, and long-term use of contact lenses."

Dry eye requires long-term management. If your dry eyes are bothering you, there are some simple things you can try to reduce symptoms:

  • Wear sunglasses when you go outside to reduce your exposure to the sun and drying wind
  • Drink plenty of water to avoid dehydration (aim for 8 to 10 glasses per day)
  • Blink regularly while reading or looking at a phone or computer screen
  • Increase the humidity in the air at home and at work
  • Reduce use of contact lenses

"If your symptoms persist after trying these at-home steps, it's time to call your eye care professional – either an optometrist or ophthalmologist," adds Dr. Lee. "Even if the clinic is closed or isn't scheduling appointments for months out, you may be able to do a remote consultation. If you’ve already been diagnosed your eye care professional may be able to help you to switch treatment strategies remotely, especially if you’re not getting relief from your current treatment or it’s causing side effects.”

CEQUA™ (cyclosporine ophthalmic solution) 0.09%: The latest prescription therapy for dry eye disease

Tears are necessary for eye health and clear vision. Every time you blink, a thin layer of your tears spreads over the front surface of the eye, but people with dry eye disease do not have enough tears to keep the eye properly lubricated.

Cyclosporine is a proven and trusted treatment for dry eye disease. CEQUA, the latest dry eye prescription therapy, features a unique formulation of cyclosporine that incorporates NCELL™, an advanced technology that helps get more of the medicine into your eye where it is needed most. This is essential to keeping the surface of the eye smooth and clear, reducing the risk of infection, and washing away particles such as dust and allergens.

Dr. Lee comments, “CEQUA is an important treatment option for dry eye disease, as it is the only prescription medicine with the highest FDA-approved concentration of cyclosporine, and its unique nanomicellar technology improves its ocular penetration into tissues to address the underlying cause of dry eye disease.”

Get CEQUA delivered for free without leaving your home

If you are already on a dry eye medication that isn’t working, or if you haven’t yet been diagnosed, contact your eye doctor to discuss your symptoms and explore treatment options. If they prescribe CEQUA, they can submit your prescription to Cequa Support™ Specialty Pharmacy – a home delivery service available to commercially insured patients. Depending on your insurance coverage, you may be able to get CEQUA at the lowest out-of-pocket cost as well as free home delivery. This means that if you qualify, you can get your prescription filled and delivered without stepping out of your home.

Once your prescription is submitted, you will receive a call from a Cequa Support representative within one business day. While on the call, a CEQUA Support Pharmacy representative will confirm your insurance, potential cost, mailing address and payment method. Upon approval, your CEQUA prescription will be delivered directly to your home within three to five business days. No signature is required and delivery is always free. Remember, it is important that you keep using CEQUA and follow your eye doctor’s instructions to make sure you get the most from your treatment.

To learn more about CEQUA, Cequa Support, and NCELL technology, visit www.CEQUA.com

 

INDICATIONS AND USAGE

CEQUA (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.

Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution.


ADVERSE REACTIONS


The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection.

Please click for Full Prescribing Information & for more information visit CEQUA.com

CEQUA™ (cyclosporine ophthalmic solution) 0.09% for topical ophthalmic use is the first and only approved cyclosporine treatment delivered with NCELL™ technology

Sun Pharma introduces CEQUA SUPPORT™ Specialty Pharmacy program to enable easy access for patients to obtain treatment

Mumbai, India & Princeton, NJ, October 14, 2019 – Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that one of its wholly-owned subsidiaries has commercialized CEQUA (cyclosporine ophthalmic solution) 0.09% in the U.S. CEQUA, which offers the highest concentration of cyclosporine for ophthalmic use approved by the U.S. Food and Drug Administration (FDA), is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye), an inflammatory disease that afflicts more than 16 million people in the U.S.1 CEQUA is the first and only FDA-approved cyclosporine treatment delivered with nanomicellar (NCELL™) technology, which helps to improve the bioavailability and physicochemical stability of cyclosporine, resulting in improved ocular tissue penetration.

“The U.S. launch of CEQUA, the third product in our growing ophthalmic portfolio, marks the availability of a truly innovative treatment option for patients with dry eye disease – an area with a high unmet medical need,” said Abhay Gandhi, CEO North America, Sun Pharma. “As a higher concentration cyclosporine product than what is currently commercially available, delivered with NCELL technology, CEQUA continues to demonstrate our leadership in creating novel formulations of proven medications.”

This announcement follows the recent publication of results from a multicenter, randomized, doublemasked, vehicle-controlled Phase 3 confirmatory study in which 744 patients with dry eye were treated either with CEQUA or its vehicle. After 12 weeks of treatment, as compared to vehicle, CEQUA showed a statistically significant improvement in the primary endpoint, percentage of patients with an increase of at least 10 mm in Schirmer’s score (a measurement of tear production) from baseline (16.6% vs. 9.2%; p<0.01). Additionally, CEQUA was associated with statistically significant improvements in the key secondary endpoints, with improvements in both corneal and conjunctival staining, compared to vehicle; improvement in total corneal staining was evident as early as one month following treatment, with 65% of eyes having completely clear central cornea after 12 weeks (vs 56.9% for vehicle; p=0.0022). Adverse events (AEs) reported in the trial were mostly mild in severity. The most commonly reported ocular AE was instillation site pain (24.2% in the CEQUA group, vs. 4.3% for vehicle); of the 24.2% of patients who reported instillation site pain in the CEQUA group, most of them reported the pain as being mild (20.7%), 3.0% reported it as moderate, and 0.5% reported it as severe.

”CEQUA is an important addition to the treatment armamentarium for keratoconjunctivitis sicca, a complex condition that is not conducive to a one-dimensional therapeutic approach,” commented Joseph Tauber, M.D., founder, Tauber Eye Center in Kansas City, MO. “The availability of CEQUA will enable eye care professionals to further tailor dry eye treatment to individual patients’ needs.”

Paul Karpecki, O.D., FAAO, director of cornea services at the Kentucky Eye Institute in Lexington, KY, added, “Keratoconjunctivitis sicca causes symptoms of burning, stinging, itching, grittiness, and dryness, underscoring the need for tolerable drug therapy with a fast onset of action. The CEQUA clinical study results strengthen the rationale for using this product as a means to penetrate the tear film and improve drug delivery of cyclosporine into the eye.”

Sun Pharma is also introducing CEQUA SUPPORT™ Specialty Pharmacy, a program designed to enable commercially insured patients to easily obtain CEQUA. Once a patient’s prescription is submitted, CEQUA SUPPORT will provide several important services including insurance plan benefits verification, prior authorization support, and appeals assistance. This program is structured to minimize out-of-pocket cost and provides free home delivery.

For more information about CEQUA, CEQUA SUPPORT Specialty Pharmacy and additional prescription processing options, go to Cequa.com or call 1-833-44-Cequa.

About CEQUA

CEQUA (cyclosporine ophthalmic solution) 0.09% is a patented, novel, proprietary nanomicellar (NCELL) formulation of cyclosporine in a clear, preservative-free, aqueous solution. CEQUA provides the highest FDA-approved concentration of cyclosporine for ophthalmic use and is the first and only approved cyclosporine treatment delivered with NCELL technology. The innovative NCELL formulation penetrates the aqueous layer of the tear film in the eye, then the nanomicelles break up to release cyclosporine to penetrate ocular tissues.

CEQUA is dosed twice daily and will be available as a single-use vial. In a multicentered, randomized, double-masked, vehicle-controlled Phase 3 confirmatory study involving 744 patients with dry eye, investigators observed clinically and statistically significant improvements in tear production and ocular surface integrity in patients treated with CEQUA, compared to vehicle. CEQUA treatment was well tolerated in the Phase 3 trial; treatment-emergent adverse events were primarily mild in intensity. In a prior Phase 2b/3 clinical trial with 455 patients, CEQUA demonstrated clinically and statistically significant increases in tear production (16.8% of patients with an increase of ≥10 mm in Schirmer’s score from baseline after 84 days of treatment, versus 8.6% for vehicle; p<0.01) and was well tolerated by the study population. Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle. From both clinical trials, the most common adverse reaction following the use of cyclosporine ophthalmic solution 0.09% was instillation site pain (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of the patients were eye irritation, blepharitis, urinary tract infection, headache, and bronchitis.

 

INDICATIONS AND USAGE

CEQUA (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).


IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.

Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution.


ADVERSE REACTIONS

The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection.

Full Prescribing Information & for more information, visit CEQUA.com


About Dry Eye Disease

Dry eye is a burdensome, chronic disease affecting millions of patients around the world, with a significant population, greater than 16 million patients, present in the United States.1-2 Dry eye disease, as defined by the National Eye Institute (NEI, a division of the U.S. National Institutes of Health [NIH]), occurs when the quantity and/or quality of tears fails to keep the surface of the eye properly lubricated. The disease causes a scratchy sensation or a feeling that something is in the eye. Other symptoms include stinging or burning, episodes of excess tearing following periods of stress, discharge, pain, and redness in the eye. The risk of developing dry eye increases with advancing age, and is more common in women than in men.

™ - All brand names and trademarks are the property of respective owners.


Disclaimer:

Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.


About Sun Ophthalmics

Backed by Sun Pharma’s global expertise in R&D, Sun Ophthalmics (the branded ophthalmic division of Sun Pharma’s wholly owned subsidiary) is leading the way through the development of innovative products and in partnership with eye care professionals. In addition to CEQUA™ (cyclosporine ophthalmic solution) 0.09%, Sun Ophthalmics markets BromSite® (bromfenac ophthalmic solution) 0.075% and Xelpros™ (latanoprost ophthalmic solution) 0.005% in the U.S. Sun Ophthalmics’ dedicated team is focused solely on the needs of eye care professionals, offering timely, knowledgeable support at every turn. The company strives to deliver products built on unique platforms that integrate seamlessly into the eye care practice, helping eye care professionals to continue providing quality medicine. Discover a brighter future in eye care at www.sunophthalmics.com.

About Sun Pharmaceutical Industries Ltd.

Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver highquality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 7% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live

References:

1. New study focuses on scope of dry eye disease in the U.S. American Optometric Association; 2017. Available at: https://www.aoa.org/news/clinical-eye-care/new-study-dry-eye-disease. Accessed September 10, 2019

2. Stapeleton, F, et al. TFOS DEWS II Epidemiology Report. The Ocular Surface. 2017;(3):334-365

 

Media Contacts:

Vinita Alexander
Tel: 609-720-8197
Vinita.alexander@sunpharma.com

Reba Auslander
Tel: 917-836-9308
Email: reba@raliancecommunications.com

XELPROS™ (latanoprost ophthalmic emulsion) 0.005%, the only FDA-approved Benzalkonium chloridefree (BAK-free) formulation of latanaprost, was recently launched by Sun Pharma for the treatment of Glaucoma or Ocular Hypertension

Now available at a fixed price from various pharmacies through XELPROS Xpress™ access program

Princeton, NJ, July 17, 2019 – Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceuticals Inc, USA, which is a wholly owned subsidiary of Mumbai-based Sun Pharmaceutical Industries Ltd. (Sun Pharma), has launched XELPROS Xpress™ - an access program for patients prescribed XELPROS™ (latanoprost ophthalmic emulsion) 0.005%. XELPROS recently became commercially available in the U.S. for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in people with open-angle glaucoma or ocular hypertension. XELPROS is the first and only benzalkonium chloride-free (BAK-free) form of latanoprost.

Through XELPROS Xpress, patients with a prescription can obtain XELPROS for a fixed price of $55 for a single month, or $37 per month for a 3-month supply. XELPROS was approved by the U.S. Food and Drug Administration (FDA) in September 2018.

“We created XELPROS Xpress to make it easier for patients to obtain XELPROS by offering direct access through pharmacies that distribute nationally and guarantee consistent cost plus high quality product and service,” said Mark Hagler, senior vice president and head of ophthalmics, oncology and long-term care at Sun Pharma. “XELPROS Xpress allows us to help patients at every step of the product ordering and fulfillment process, ensuring that they have the best possible experience.”

XELPROS Xpress is designed to facilitate access to XELPROS without prior authorization, step therapy, copay cards, or coupons. The program also provides prompt fulfillment services and refill reminders for patients. XELPROS is contraindicated in patients with known hypersensitivity to latanoprost, or any other product ingredients. The most common ocular adverse reactions reported in clinical trials (incidence ≥5%) for XELPROS were eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening.

Eye care professionals and patients can obtain more information about XELPROS and XELPROS Xpress at Xelpros.com.

About XELPROS™

XELPROS™ (latanoprost ophthalmic emulsion) 0.005%, a translucent ophthalmic emulsion, is a topical formulation of latanoprost, a prostaglandin analogue that is used as first-line treatment for open-angle glaucoma or ocular hypertension. It is the first and only BAK-free form of latanoprost. The recommended dosage of XELPROS is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. Reduction of IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. Across multiple XELPROS clinical trials, the most frequently reported ocular adverse reactions were eye pain/stinging upon instillation and ocular hyperemia (redness), reported in 55% and 41% of patients treated with XELPROS, respectively. Less than 1% of patients discontinued therapy because of intolerance to these adverse events.


IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS

XELPROS is contraindicated in patients with known hypersensitivity to latanoprost, or any other ingredients in this product.


WARNINGS AND PRECAUTIONS

Pigmentation: XELPROS may cause changes to pigmented tissues. The most frequently reported changes are increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as XELPROS is administered. After discontinuation of XELPROS iris pigmentation is likely to be permanent. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known.

Eyelash Changes: XELPROS may gradually cause changes to eyelashes, vellus hair in the treated eye including increased length, thickness, pigmentation and number of lashes. The changes are usually reversible upon discontinuation of treatment.

Intraocular Inflammation: XELPROS should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.

Macular Edema: XELPROS should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Herpetic Keratitis: XELPROS should be used with caution in patients with a history of herpetic keratitis. XELPROS should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated.

Bacterial Keratitis: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.

Use with Contact Lens: Contact lenses should be removed prior to administration of XELPROS and may be reinserted 15 minutes following administration.


ADVERSE REACTIONS

The most common ocular adverse reactions reported in clinical trials (incidence ≥5%) for XELPROS were eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening.


DRUG INTERACTIONS

Precipitation may occur if drugs containing thimerosal are used concomitantly with XELPROS. If such drugs are used, they should be administered at least five (5) minutes apart.

Please click here for Full Prescribing Information.


Disclaimer:

Statements in this “Document” describing Sun Pharma’s and SPARC’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.


About Sun Pharmaceutical Industries Inc., USA (SPII)

SPII is a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd, a Mumbai-based global specialty generic company that provides innovative, high-quality, affordable medicines trusted by customers and patients in more than 150 countries around the world. Sun Pharma's global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 7% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live.

About Sun Ophthalmics

Backed by Sun Pharma’s global expertise in R&D, Sun Ophthalmics (the branded ophthalmic division of Sun Pharma’s wholly owned subsidiary) is leading the way through the development of innovative products and in partnership with eye care professionals. In the U.S., Sun Ophthalmics markets BromSite® (bromfenac ophthalmic solution) 0.075% and XELPROS™ (latanoprost ophthalmic solution) 0.005% and will soon commence marketing CEQUA™ (cyclosporine ophthalmic solution) 0.09%. Sun Ophthalmics’ dedicated team is focused solely on the needs of eye care professionals, offering timely, knowledgeable support at every turn. The company strives to deliver products built on unique platforms that integrate seamlessly into the eye care practice, helping eye care professionals to continue providing quality medicine. Discover a brighter future in eye care at www.sunophthalmics.com.


Media Contacts:

Vinita Alexander
Tel Direct +609-720-8197
Email vinita.alexander@sunpharma.com

Reba Auslander
Tel Direct +917-836-9308
Email reba@raliancecommunications.com

XELPROS™ (latanoprost ophthalmic emulsion) 0.005% for topical ophthalmic use is the first and only benzalkonium chloride-free (BAK-free) form of latanoprost

Mumbai, India, Princeton, NJ, September 14, 2018 – Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) and Sun Pharma Advanced Research Company Ltd. (Reuters: SPRC.BO, Bloomberg: SPADV IN, NSE: SPARC, BSE: 532872, “SPARC”) today announced U.S. Food and Drug Administration (USFDA) approval for the New Drug Application (NDA) of XELPROS™ (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension. This approval is from Sun Pharma’s Halol (Gujarat, India) facility.

Sun Pharma in-licensed XELPROS™ from SPARC in June 2015 and this approval will trigger a milestone payment to SPARC. SPARC is also eligible for milestone payments and royalties on commercialization of XELPROS™ in the US.

XELPROS™ is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations. XELPROS™ is developed using SPARC’s proprietary Swollen Micelle Microemulsion (SMM) technology.

“As the only BAK-free version of latanoprost, XELPROS™ will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension,” said Abhay Gandhi, CEO, North America, Sun Pharma. “This approval, coming less than one month following the approval of CEQUA™ (cyclosporine ophthalmic solution) 0.09%, reaffirms the strength of Sun Pharma’s fast-growing Ophthalmics division and its commitment to serving the needs of patients with ocular disorders.”

Anil Raghavan, CEO, SPARC said, “Approval of XELPROS™ by USFDA is a significant milestone for SPARC. It is also a validation of our SMM technology which helps to solubilize drugs that have limited or no solubility thus eliminating the need for benzalkonium chloride (BAK).”

In randomized, controlled clinical trials of patients with open-angle glaucoma or ocular hypertension with a mean baseline Intraocular pressure (IOP) of 23-26 mmHg, XELPROS™ lowered IOP by a mean of up to 6-8 mmHg.

XELPROS™ will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries Ltd.’s wholly owned subsidiary.

About XELPROS™

XELPROS™ (latanoprost ophthalmic emulsion) 0.005%, a translucent ophthalmic emulsion, is a topical formulation of latanoprost, a prostaglandin analogue that is used as first-line treatment for open-angle glaucoma or ocular hypertension. It is the first and only BAK-free form of latanoprost. The recommended dosage of XELPROS™ is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. Reduction of IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours.

Across multiple XELPROS™ clinical trials, the most frequently reported ocular adverse reactions were eye pain/stinging upon instillation and ocular hyperemia (redness), reported in 55% and 41% of patients treated with XELPROS™, respectively. Less than 1% of patients discontinued therapy because of intolerance to these adverse events.


IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS

XELPROS™ is contraindicated in patients with known hypersensitivity to latanoprost, or any other ingredients in this product.

WARNINGS AND PRECAUTIONS

Pigmentation: XELPROS may cause changes to pigmented tissues. The most frequently reported changes are increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as XELPROS is administered. After discontinuation of XELPROS iris pigmentation is likely to be permanent. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known.

Eyelash Changes: XELPROS may gradually cause changes to eyelashes, vellus hair in the treated eye including increased length, thickness, pigmentation and number of lashes. The changes are usually reversible upon discontinuation of treatment.

Intraocular Inflammation: XELPROS should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.

Macular Edema: XELPROS should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Herpetic Keratitis: XELPROS should be used with caution in patients with a history of herpetic keratitis. XELPROS should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated.

Bacterial Keratitis: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.

Use with Contact Lens: Contact lenses should be removed prior to administration of XELPROS and may be reinserted 15 minutes following administration.


ADVERSE REACTIONS

The most common ocular adverse reactions reported in clinical trials (incidence ≥5%) for XELPROS were eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening.

DRUG INTERACTIONS

Precipitation may occur if drugs containing thimerosal are used concomitantly with XELPROS. If such drugs are used, they should be administered at least five (5) minutes apart.

Please click here for Full Prescribing Information & for more information visit www.MyXelpros.com


About Open-angle Glaucoma

Open-angle glaucoma (also known as primary or chronic glaucoma) is the most common form of glaucoma, accounting for more than 90% of cases. It is caused by clogging of the drainage canals in the eye, resulting in elevated intraocular pressure (IOP). A lifelong condition, open-angle glaucoma develops slowly, causing ocular nerve damage that gradually affects a patient’s visual function.

In the U.S., glaucoma is a leading cause of irreversible blindness, second only to macular degeneration. More than 2.25 million Americans older than 40 years have open-angle glaucoma. Worldwide, glaucoma is the second leading cause of blindness, surpassed only by cataracts; more than 2 million people around the world will develop open-angle glaucoma each year, and more than 3 million are bilaterally blind (i.e., in both eyes) from open-angle glaucoma1.


About Ocular Hypertension

Ocular hypertension is a condition in which IOP is greater than 21 mmHg, the widely accepted upper limit of normal IOP in the general population. In individuals with ocular hypertension, fluid from the front of the eye does not drain properly, causing IOP to build up. Although ocular hypertension can cause glaucoma, it is not the same as glaucoma; with ocular hypertension, the optic nerve appears normal and there are no signs of vision loss. However, individuals with ocular hypertension are considered “glaucoma suspects,” and should visit their ophthalmologist regularly to be checked for glaucoma. Population studies in various countries suggest that ocular hypertension affects an estimated 4-10% of individuals older than 40 years. The prevalence of ocular hypertension is 10-15 times greater than that of open-angle glaucoma.

References

1. Biggerstaff KS. Primary open-angle glaucoma (POAG). Medscape, 2018. https://emedicine.medscape.com/article/1206147-overview#a6. Accessed September 5, 2018.


Disclaimer:

Statements in this “Document” describing Sun Pharma’s and SPARC’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.

About Sun Ophthalmics

Backed by Sun Pharma’s global expertise in R&D, Sun Ophthalmics (the branded ophthalmic division of Sun Pharma’s wholly owned subsidiary) is leading the way through the development of innovative products and in partnership with eye care professionals. In the U.S., Sun Ophthalmics market BromSite® (bromfenac ophthalmic solution) 0.075%, and will soon commence marketing CEQUA™ (cyclosporine ophthalmic solution) 0.09% and XELPROS (latanoprost ophthalmic solution) 0.005%, both of which were recently approved by the USFDA. Sun Ophthalmics’ dedicated team is focused solely on the needs of eye care professionals, offering timely, knowledgeable support at every turn. The company strives to deliver products built on unique platforms that integrate seamlessly into the eye care practice, helping eye care professionals to continue providing quality medicine. Discover a brighter future in eye care at www.sunophthalmics.com.

About Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050):

Sun Pharma is the world's fifth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun Pharma's global presence is supported by 42 manufacturing facilities spread across 6 continents, R&D centers across the globe and a multi-cultural workforce comprising over 50 nationalities. In India, the company enjoys leadership across 13 different classes of doctors with 32 brands featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging markets covers over 100 markets and 6 markets in Western Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 3 global markets. Its API business footprint is strengthened through 14 world class API manufacturing facilities across the globe. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of approximately 8% of annual revenues. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live.

 

About Sun Pharma Advanced Research Company Ltd. (CIN - L73100GJ2006PLC047837):

Sun Pharma Advanced Research Company Ltd. (SPARC) is a clinical stage bio-pharmaceutical company focused on continuously improving standards of care for patients globally, through innovation in therapeutics and delivery. SPARC aims to consistently lower costs and improve operational efficiencies to advance availability and affordability of cures for patients across the world. More information about the company can be found at www.sparc.life

CEQUA (cyclosporine ophthalmic solution) 0.09% for topical ophthalmic use is the first and only dry eye treatment to combine cyclosporine A with nanomicellar technology

Mumbai, India, Princeton, NJ, August 16, 2018 – Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that Sun Pharma has received approval for CEQUA (cyclosporine ophthalmic solution) 0.09%, from the U.S. Food and Drug Administration (F DA). CEQUA is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).

CEQUA provides the highest FDA-approved concentration of cyclosporine A (CsA) and is the first and only approved CsA product that incorporates a nanomicellar technology. The innovative nanomicellar formulation allows the CsA molecule to overcome solubility challenges, penetrate the eye’s aqueous layer and prevents the release of the active lipophilic molecule prior to penetration. In the Phase 3 confirmatory trial on CEQUA, after 12 weeks of treatment, as compared to vehicle, CEQUA showed statistically significant improvement in the primary endpoint, Schirmer’s score (a measurement of tear production) (p<0.01). Improvements in secondary endpoints (i.e. ocular staining assessments) were seen as early as 1 month after initiating treatment. CEQUA is dosed twice daily and will be available as a single-use vial.

The nanomicellar formulation technology uses micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules formed at a well-defined concentration. The small size of the nanomicelles facilitates entry into corneal and conjunctival cells, enabling delivery of high concentrations of CsA.

“Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated,” said Abhay Gandhi, CEO, North America, Sun Pharma. “The U.S. FDA approval of CEQUA represents a long-awaited dry eye treatment option and is an important milestone in the development of Sun’s Ophthalmics business. CEQUA, with its novel nanomicellar formulation for a proven dry eye medication, delivers a lipophilic molecule in a clear solution form.”

Additionally, Jodi Luchs, MD, the principal investigator behind the CEQUA confirmatory Phase 3 trial, noted: “Dry eye is a complex disease that lacks a ‘one-size-fits-all’ approach. As a clinician treating a high volume of dry eye patients, it’s important to have multiple treatment modalities available at my disposal. Given its strong clinical trial performance, the approval of CEQUA is welcomed news, and I look forward to offering my patients this compelling new option.”

CEQUA (cyclosporine ophthalmic solution) 0.09%, for topical ophthalmic use will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary.


About CEQUA™

CEQUA (cyclosporine A, ophthalmic solution) is a patented, novel, proprietary nanomicellar formulation of cyclosporine A, 0.09% in a clear, preservative-free, aqueous solution. In a multicentered, randomized, double-masked, vehicle-controlled Phase 3 confirmatory study, 744 patients with dry eye were treated either with CEQUA or its vehicle. After 12 weeks of treatment, as compared to vehicle, CEQUA showed statistically significant improvement in the primary end point, Schirmer’s score (a measurement of tear production) (p<0.01). Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle, with some showing improvement as early as 1 month following treatment. Adverse events reported in the trial were mostly mild in nature. In a prior Phase 2b/3 clinical trial with 455 patients, CEQUA demonstrated increased tear production (p<0.01) and was well tolerated by the study population. Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle. The most common adverse reaction following the use of cyclosporine ophthalmic solution 0.09% was instillation site pain (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of the patients were eye irritation, blepharitis urinary tract infection, headache, and bronchitis.


INDICATIONS AND USAGE

CEQUA (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).


IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.

Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution.


ADVERSE REACTIONS

The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection.

Please click for Full Prescribing Information & for more information visit CEQUA.com


About Dry Eye Disease

Dry eye is a burdensome, chronic disease affecting millions of patients around the world, with a significant population, greater than 16 million patients, present in the United States. Dry eye disease, as defined by the National Eye Institute (NEI, a division of the U.S. National Institutes of Health [NIH]), occurs when the quantity and/or quality of tears fails to keep the surface of the eye properly lubricated. The disease causes a scratchy sensation or a feeling that something is in the eye. Other symptoms include stinging or burning, episodes of excess tearing following periods of stress, discharge, pain, and redness in the eye. The risk of developing dry eye increases with advancing age, and is more common in women than in men.

TM - All brand names and trademarks are the property of respective owners.


Disclaimer:

Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.


About Sun Ophthalmics

Backed by Sun Pharma’s global expertise in R&D, Sun Ophthalmics (the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary) is leading the way through the development of innovative products and in partnership with eye care professionals. Sun Ophthalmics markets BromSite® (bromfenac ophthalmic solution) 0.075% in the U.S. Other candidates in Sun Ophthalmics’ development pipeline include Xelpros™ (latanoprost ophthalmic solution) 0.005% and DexaSite™ (dexamethasone) 0.1%. Sun Ophthalmics’ dedicated team is focused solely on the needs of eye care professionals, offering timely, knowledgeable support at every turn. The company strives to deliver products built on unique platforms that integrate seamlessly into the eye care practice, helping eye care professionals to continue providing quality medicine. Discover a brighter future in eye care at www.sunophthalmics.com.


About Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050):

Sun Pharma is the world's fifth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun Pharma's global presence is supported by 41 manufacturing facilities spread across 6 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. In India, the company enjoys leadership across 13 different classes of doctors with 32 brands featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging markets covers over 100 markets and 6 markets in Western Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 3 global markets. Its API business footprint is strengthened through 14 world class API manufacturing facilities across the globe. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of approximately 8% of annual revenues. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live.

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