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.