FDA approves Xelprost for glaucoma/ocular hypertension.- Sun Pharma.
Sun Pharmaceutical and SPARC announced FDA 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 Xelprost 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 Xelprost in the US. Xelprost is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations and was developed using SPARC�s proprietary Swollen Micelle Microemulsion (SMM) technology.
Approval is based on randomized, controlled clinical trials of patients with open-angle glaucoma or ocular hypertension with a mean baseline Intraocular pressure (IOP) of 23-26 mmHg. The results revealed that Xelprost lowered IOP by a mean of up to 6-8 mmHg.
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