Hyderabad — Gland Pharma announced on Wednesday that it has received approval from the United States Food and Drug Administration (USFDA) for its generic version of Latanoprostene Bunod Ophthalmic Solution (0.024%), a medication used to treat elevated eye pressure.
The approved product is the therapeutic equivalent of Bausch & Lomb’s Vyzulta and is indicated for lowering intraocular pressure (IOP) in patients suffering from open-angle glaucoma or ocular hypertension, the company said in a statement.
Gland Pharma further stated that it is the exclusive first-to-file applicant for this generic drug and, as a result, is eligible for 180 days of market exclusivity in the U.S.
According to IQVIA data, the reference product generated sales of approximately USD 171 million in the U.S. for the 12-month period ending February 2025.
Despite the regulatory milestone, shares of Gland Pharma ended 1.04% lower on Wednesday at ₹1,398.35 on the Bombay Stock Exchange.
