PDUFA date for novel glaucoma candidate latanoprostene bunod

The US Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) date of August 24, 2017 for its decision on the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%.

Under development by Bausch + Lomb, a wholly-owned ophthalmic business of Canada’s Valeant Pharmaceuticals International (TSX: VRX), latanoprostene bunod (proposed trade name Vesneo) is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma (OAG) or ocular hypertension (OHT). The drug is licensed from French firm NicOx (Euronext Paris: COX), which will co-promote the product in the USA. NicOx shares were up 4.4% at 9.48 euros by early afternoon.

In July 2016, the FDA issues a complete response letter relating to concerns at the drug’s manufacturing facility, thus delaying its review. If approved, latanoprostene bunod would be the first nitric-oxide donating prostaglandin F2α analog for ophthalmic use.