The FDA has approved a new drug application for Xelpros to reduce IOP in open-angle glaucoma and ocular hypertension, Sun Pharmaceutical Industries and Sun Pharma Advanced Research Company announced in a joint press release.
Xelpros (latanoprost ophthalmic solution 0.005%) is the first latanoprost product not formulated with the preservative benzalkonium chloride and was developed with SPARC’s Swollen Micelle Microemulsion technology, the release said.
It was shown to reduce IOP in patients with open-angle glaucoma and ocular hypertension up to a mean of 6 mm Hg to 8 mm Hg in randomized clinical trials.
“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,” Sun Pharma North America CEO Abhay Gandhi said in the release.
Sun Ophthalmics will commercialize Xelpros in the United States.