Gland Pharma Gets USFDA Nod for Glaucoma Drug

30 Apr 2025 , 03:28 PM

On April 30, Gland Pharma issued a press release that it has received USFDA approval for its ANDA of Latanoprostene Bunod Ophthalmic Solution, 0.024%.

The drug is a generic of VYZULTA Ophthalmic Solution, 0.024%, which is made by Bausch and Lomb, Inc. The ophthalmic solution is used to decrease intraocular pressure in open-angle glaucoma or ocular hypertension patients. They are severe eye disorders that, when not treated, can cause vision loss.

Gland Pharma has secured exclusive rights as the first-to-file sponsor of this generic product. This makes it eligible for 180 days of marketing exclusivity in the US. The 180-day exclusivity gives a benefit to Gland Pharma by being the only generic drug to be available in the U.S. market for some time, giving a competitive edge and strong potential for revenue growth.

The clearance indicates the increasing footprint of Gland Pharma in the pharma industry of the U.S. and scales up its pipeline of ophthalmic complex generic products and injectables. By doing so, Gland Pharma is constantly enhancing its pipeline of U.S.-approved generics within its business model of supplying quality, value-for-money variants for regulated markets.