Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Latanoprostene Bunod Ophthalmic Solution, 0.024%.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VYZULTA Ophthalmic solution, 0.024%, of Bausch and Lomb, Inc. This Product is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Gland Pharma is the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity. According to IQVIA, the product had US sales of around $171 million for the twelve months ending February 2025.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
