FDA raises concerns over manufacturing practice of Valeant’s new ophthalmic solution

Valeant has received a complete response letter (CRL) from the FDA for latanoprostene bunod (LBN) ophthalmic solution 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.

FDA has raised concerns relating to a current good manufacturing practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida, US.

The US regulator has identified some deficiencies at the manufacturing facility.

The FDA's letter 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 the new ophthalmic solution.

Valeant said that it will meet with the FDA as soon as possible to work on a resolution and address these concerns.

Earlier this month, Valeant and Nicox announced the results of a Phase III study for LBN ophthalmic solution 0.024%.

According to Valeant, the LUNAR study results demonstrated that LBN 0.024% administered once daily (QD) in the evening was not only non-inferior to timolol maleate 0.5% dosed twice daily (BID) in subjects with OAG or OHT over 3 months of treatment, but also provided significantly greater IOP reduction (P≤0.025) at all but the earliest time point evaluated.

Valeant develops and markets a wide range of pharmaceutical products in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics.