Sun Pharma gets USFDA nod for specialty eye drug Xelpros

Moneycontrol News

Sun Pharma, India's largest drug maker on Friday said it got an approval from USFDA for its specialty opthalmic drug Xelpros, which is used to treat chronic eye disease glaucoma.

The New Drug Application (NDA) of Xelpros was filed from the Halol site in Gujarat. Sun Pharma management earlier indicated that the peak sales guidance of Xeplros is expected to be in the range of $50-$75 million over two to three years.

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 commercialisation of Xelpros in the US. SPARC, is research led company which was demerged from parent Sun Pharma in 2006.

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 that may cause allergic reactions. Xelpros is developed using SPARC’s proprietary Swollen Micelle Microemulsion (SMM) technology.

“As the only BAK-free version of latanoprost, XELPROSTM 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,” said

Anil Raghavan, CEO, SPARC.

Xelpros will be commercialised in the US by Sun Ophthalmics, the branded ophthalmic division of Sun Pharma.

In the US, 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 that is in both eyes from open-angle glaucoma.