Sun Pharmaceutical Industries announced FDA approval of Xelpros (latanoprost ophthalmic emulsion 0.005%) for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.
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, according to Sun Pharma. Xelpros is developed using SPARC’s proprietary Swollen Micelle Microemulsion (SMM) technology. Sun Pharma in-licensed Xelpros from SPARC in June 2015 and this approval will trigger a milestone payment to SPARC, which is also eligible for milestone payments and royalties on commercialization of Xelpros in the United States.
“As the only BAK-free version of latanoprost, Xelpros will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension,” Abhay Gandhi, CEO, North America, Sun Pharma, said in a company news release. “This approval, coming less than 1 month following the approval of Cequa (cyclosporine ophthalmic solution) 0.09%, reaffirms the strength of Sun Pharma’s fast-growing ophthalmics division and its commitment to serving the needs of patients with ocular disorders.”
Anil Raghavan, CEO, SPARC said, “Approval of Xelpros by the FDA is a significant milestone for SPARC. It is also a validation of our SMM technology which helps to solubilize drugs that have limited or no solubility thus eliminating the need for benzalkonium chloride (BAK).”
In randomized, controlled clinical trials of patients with open-angle glaucoma or ocular hypertension with a mean baseline IOP of 23-26 mmHg, Xelpros lowered IOP by a mean of up to 6-8 mmHg.
Xelpros will be commercialized in the United States by Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries Ltd.’s wholly owned subsidiary.
The approval of Xelpros comes just weeks after Sun Pharma received FDA approval for dry eye treatment Cequa (cyclosporine ophthalmic solution 0.09%). Cequa provides the highest FDA-approved concentration of cyclosporine A (CsA) and is the first and only approved CsA product that incorporates a nanomicellar technology, according to Sun Pharma.