FDAnews Drug Daily Bulletin

Bausch + Lomb Falls Short Again in Seeking Eye-Drops Approval

Aug. 11, 2017

Lingering problems at the Bausch + Lomb manufacturing plant in Tampa have meant a second failure to gain the FDA’s approval for a new formulation of eye drops to treat glaucoma.

The parent company, Valeant Pharmaceuticals, said it received a complete response letter from the FDA regarding the application for approval of latanoprostene bunod ophthalmic solution, an intraocular pressure-lowering eye drop for patients with open angle glaucoma or ocular hypertension.

A February 2016 FDA inspection of the Tampa plant found excessive levels of particulates and microbiological contamination. The agency issued a similar CRL in 2016 in response to Valeant’s initial application for approval of the eye drops. The company said it will continue to work with the agency to advance the approval process.

View today's stories