FDA concern at manufacturing of Valeant's Vesneo eye drop

The US Food and Drug Administration has told Canada-based Valeant Pharmaceuticals International (TSX:VRX) that an inspection has identified deficiencies in the manufacturing of Vesneo (latanoprostene bunod), an ophthalmic solution for open angle glaucoma or ocular hypertension.

A Complete Response Letter has been written by the FDA to Valeant relating to the company’s New Drug Application (NDA) for the treatment, following a current Good Manufacturing Practice inspection at the Florida manufacturing facility of Bausch + Lomb, the ophthalmology subsidiary of the Quebec-based pharma company.

Despite deficiencies being noted by the FDA in the inspection, Valeant is keen to stress that the regulator did not identify any efficacy or safety concerns with respect to the NDA, or suggest that additional clinical trials were needed for the approval of the application.