Bausch + Lomb and NicOx resubmit US NDA for novel glaucoma candidate

Bausch + Lomb, a wholly-owned subsidiary of Canada’s Valeant Pharmaceuticals International (TSX: VRX) and French biotech firm NicOx (Euronext Paris: COX) have re-submitted  a New Drug Application to the US Food and Drug Administration seeking approval for latanoprostene bunod ophthalmic solution, 0.024%.

Last July, the FDA delayed approval of the drug, proposed trade name Vesneo, issuing a Complete Response Letter that identified deficiencies in the manufacturing of the compound following a current Good Manufacturing Practice inspection at the Florida manufacturing facility of Bausch + Lomb.

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). The data submitted in the NDA support latanoprostene bunod as the first nitric-oxide donating prostaglandin F2α analog for ophthalmic use.