Valeant setback on eye drug approval

Ahead of the 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%, the US Food and Drug Administration announced another setback for Valeant Pharmaceuticals International (TSX: VRX).

Before markets opened today, Canada-based Valeant said it has received a Complete Response Letter (CRL) from the FDA regarding the NDA for latanoprostene bunod, an investigative intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The drug has the proposed trade name Vesneo.

The CRL from the FDA only refers to a current Good Manufacturing Practice (cGMP) inspection at wholly-owned subsidiary Bausch + Lomb's manufacturing facility in Tampa, Florida. The FDA did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.