Sun Pharma and its research arm Sun Pharma Advanced Research Company Ltd (SPARC) declared that the US Food and Drug Administration (US FDA) has granted approval for its new drug application (NDA), used to reduce open-angle glaucoma or ocular hypertension, XELPROS ™ 0.005%.
Sun Pharma and SPARC said in a joint statement, “This approval is from Sun Pharma’s Halol, Gujarat facility. Sun Pharma in-licensed XELPROS ™ from SPARC in June 2015 and this approval will trigger a milestone payment to SPARC.” It also added, SPARC is also eligible for milestone payments and royalties on the commercialisation of XELPROS ™ in the US.
Sun Pharma CEO North America Abhay Gandhi said, “This approval, coming less than one month following the approval of CEQUA (cyclosporine ophthalmic solution) 0.09 per cent, reaffirms the strength of Sun Pharma’s fast-growing Ophthalmics division and its commitment to serving the needs of patients with ocular disorders.”
Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries Ltd wholly-owned subsidiary will commercialise XELPROS ™ in the US. XELPROS ™ is developed using SPARC’s proprietary Swollen Micelle Microemulsion (SMM) technology.