By: IPP Bureau
Last updated : May 01, 2025 1:29 pm
This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Gland Pharma Limited, a generic injectable & ophthalmicfocused pharmaceutical company, 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. 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 approximately US$ 171 million for the twelve months ending February 2025.