Valeant Pharmaceuticals`s subsidiary, Bausch + Lomb, and Nicox have resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for latanoprostene bunod ophthalmic solution, 0.024%.
Latanoprostene bunod is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma (OAG) or ocular hypertension (OHT), explained Valeant in its press release.
Latanoprostene bunod was licensed by Nicox to Bausch + Lomb.
The data submitted in the NDA support latanoprostene bunod as the first nitric-oxide donating prostaglandin F2alpha analog for ophthalmic use, said the company.