Gland Pharma Receives USFDA Approval for Latanoprostene Bunod Ophthalmic Solution

Gland Pharma Limited has received approval from the 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. It 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. The product had US sales of approximately USD 171 million for the twelve months ending February 2025.