Sun Pharmaceutical Industries said it has got US Food and Drug Administration approval for a new eye drug that will be used for lowering intraocular pressure or IOP in patients with open-angle glaucoma or ocular hypertension.
The medicine, latanoprost ophthalmic emulsion, was developed by group company Sun Pharma Advanced Research Co (SPARC), and was licensed by Sun Pharma, one of India’s largest drug makers.
The approval will trigger a milestone payment to SPARC, it said.
SPARC is also eligible for milestone payments and royalties on commercialization of XELPROSTM in the US, it added.
Unlike most drugs submitted for approval by Indian companies latanoprost is not the generic version of an existing drug, but a new drug designed by SPARC.
Sun Pharma said the drug, branded XELPROSTM, is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations.
SPARC used its Swollen Micelle Microemulsion technology to solubilize drugs that have limited or no solubility. This, said the company, eliminated the need for benzalkonium chloride (BAK).
“As the only BAK-free version of latanoprost, XELPROSTM will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension,” said Abhay Gandhi, CEO, North America, Sun Pharma.
The US FDA approval has come less than one month following the approval of CEQUA (cyclosporine ophthalmic solution).
In randomized, controlled clinical trials of patients with open-angle glaucoma or ocular hypertension with a mean intraocular pressure of 23-26 mmHg, the drug was able to lower IOP by around 6-8 mmHg.
XELPROSTM will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries Ltd.’s wholly owned subsidiary.
It will be manufactured at Sun Pharma’s Halol (Gujarat, India) facility.