Latest News | Gland Pharma Gets USFDA Nod for Generic Ophthalmic Solution

New Delhi, Apr 30 (PTI) Gland Pharma on Wednesday said it has received approval from the US health regulator for a generic medication to treat conditions related to high pressure in the eye.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Latanoprostene Bunod Ophthalmic Solution, (0.024 per cent), the drug firm said in a statement.

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The company's product is bioequivalent and therapeutically equivalent to Bausch and Lomb, Inc's Vyzulta ophthalmic solution, it added.

The product is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

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The company is the exclusive first-to-file and is eligible for 180 days of generic drug exclusivity, Gland Pharma said.

According to IQVIA, the product had sales of around USD 171 million in the US for the 12 months ending February 2025.

Shares of Gland Pharma on Wednesday ended 1.04 per cent down at Rs 1,398.35 apiece on the BSE.

(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)