Valeant Pharmaceuticals received a letter from the Food and Drug Administration (FDA) on Friday, which raised concerns about the company’s experimental eye disease treatment, Vesneo.
The complete response letter sent by the agency explained it found ‘deficiencies’ in a Tampa, Florida-based Bausch + Lomb manufacturing facility during a standard Current Good Manufacturing Practice inspection.
No specific safety or efficacy issues were mentioned in the note, but it does prolong Valeant’s attempt at getting Vesneo regulatory approval.
The drug is a latanoprostene bunod ophthalmic solution, reported FierceBiotech. Valeant submitted a new drug application (NDA) for it hoping to obtain a treatment indication for patients diagnosed with ocular hypertension or open angle glaucoma.
The Canadian company is seeking a turnaround after a rough year where it came under fire for suspicious drug pricing policies and a relationship with a specialty pharmacy named Philidor.
Valeant gained regulatory approval for a psoriasis drug brodalumab earlier this week. The FDA’s decision was initially inconclusive due to the drug’s incomplete data concerning the risk of suicide, but the organization granted approval as long as a risk program is installed to mitigate the danger of suicide from occurring.
A statement posted by Valeant said it would meet with the FDA soon to resolve the matter related to Vesneo.
