Sun Pharmaceutical Industries Ltd. has said that it has received U.S. Food and Drug Administration (USFDA) approval for the New Drug Application (NDA) of XELPROS TM (latanoprost ophthalmic emulsion) 0.005 per cent 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 TM 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 TM in the US . XELPROS TM is the first and only form of latanoprost that is not formulated with benzalkonium chlo ride (BAK), a preservative commonly used in topical ocular preparations. XELPROS TM is developed using SPARC’s proprietary Swollen Micelle Microemulsion (SMM) technology. Meanwhile, shares of the company were trading at Rs 662 apiece up 1.87 per cent from the previous close at 11:00 hrs on BSE.