Sun Pharma Announce FDA Approval of Xelpros to Treat Open-angle Glaucoma or Ocular Hypertension

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  • Xelpros is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK)
  • BAK is associated with increased incidence of Ocular Surface Disease (OSD)


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”) announced on 9/14/18 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.

BAK is a common preservative in topical ocular preparations; however, prolonged use may lead to deleterious effects on the ocular surface, affecting quality of life and reducing adherence to treatment and overall outcomes. Use of BAK has been associated with the increased risk of developing OSD (Ocular Surface Disease). Patients with OSD, experience symptoms of ocular discomfort like dryness, burning or stinging, itching, irritation, tearing, etc. These symptoms can have a substantial impact on a patient’s quality of life and potentially lead to reduced adherence with treatment regimens.

“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.”