Gland Pharma Secures USFDA Nod for Eye Pressure Medication

Gland Pharma has received USFDA approval for its generic Latanoprostene Bunod Ophthalmic Solution, intended to treat high eye pressure related conditions. The drug is bioequivalent to Vyzulta and aims to reduce intraocular pressure in glaucoma or hypertension patients, granting 180 days of market exclusivity.

Gland Pharma announced on Wednesday that it has received approval from the US Food and Drug Administration (USFDA) for a generic medication designed to address elevated eye pressure.

The newly approved solution, Latanoprostene Bunod Ophthalmic Solution (0.024 per cent), matches both the bioequivalence and therapeutic equivalence of Bausch and Lomb's Vyzulta, according to the company's statement.

This product is targeted at reducing intraocular pressure in patients diagnosed with open-angle glaucoma or ocular hypertension, and Gland Pharma holds exclusive first-to-file status, granting it 180 days of generic drug exclusivity. Market data from IQVIA indicates US sales for the product reached approximately USD 171 million for the year ending February 2025.

Gland Pharma shares closed with a 1.04% decline at Rs 1,398.35 each on the BSE on Wednesday.

(With inputs from agencies.)