Sun Pharma, SPARC announce FDA approval of Xelpros

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Xelpros (latanoprost ophthalmic emulsion) 0.005 per cent for topical ophthalmic use is the first and only benzalkonium chloride-free (BAK-free) form of latanoprost

Sun Pharmaceutical and Sun Pharma Advanced Research Company recently announced US Food and Drug Administration (USFDA) approval for the New Drug Application (NDA) of Xelpros (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 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.

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.