Gland Pharma announced on Wednesday, 30 April, that it had received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for latanoprostene bunod ophthalmic solution, 0.024%.

The approved product is both bioequivalent and therapeutically equivalent to VYZULTA Ophthalmic Solution, 0.024%, developed by Bausch and Lomb, Inc.

This medication is prescribed to lower intraocular pressure (IOP) in patients diagnosed with open-angle glaucoma or ocular hypertension. Open-angle glaucoma is the most prevalent form of glaucoma, a condition that can damage the optic nerve due to increased eye pressure.

Gland Pharma holds the exclusive First-to-File (FTF) status for this drug, granting it 180 days of generic market exclusivity in the US.

As per IQVIA data, the product recorded US sales of roughly $171 million in the 12 months ending February.

Previously, Medical Dialogues reported that Gland Pharma had also received USFDA approval for Latanoprost Ophthalmic Solution, 0.005%, used for managing high eye pressure in patients with similar conditions.

Founded in 1978 in Hyderabad, Gland Pharma has evolved from a contract manufacturer of small-volume parenterals to a globally recognized, injectable-focused pharmaceutical firm. The company serves over 60 countries, including the US, Europe, Canada, Australia, and India.

Operating mainly on a business-to-business (B2B) model, Gland Pharma specializes in the development, manufacturing, and marketing of sterile injectable products. Its extensive portfolio includes vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology drugs, and ophthalmic solutions.

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