MUMBAI, India & PRINCETON, N.J.—Sun Pharmaceutical Industries and Sun Pharma Advanced Research Company (SPARC) have received U.S. Food and Drug Administration approval for the New Drug Application (NDA) of Xelprostm (latanoprost ophthalmic emulsion) 0.005 percent for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The approval is from Sun Pharma’s Halol facility in Gujarat, India. Sun Pharma in-licensed Xelprostm from SPARC in June 2015, and the approval will trigger a payment to SPARC. SPARC is also eligible for payments and royalties on commercialization of Xelprostm in the U.S., the company said in a statement.

Xelprostm is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations. Xelprostm was developed using SPARC’s proprietary Swollen Micelle Microemulsion 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 percent, reaffirms the strength of Sun Pharma’s fast-growing ophthalmics division and its commitment to serving the needs of patients with ocular disorders.”

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