Gland Pharma ANDA used in Glaucoma treatment gets USFDA approval

Gland Pharma on Wednesday, April 30, said it has 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 product is bioequivalent and therapeutically equivalent to the reference listing drug VYZULTA Opthalmic solution, 0.024% of Bausch and Lomb, Inc.

The product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension, the company said in an exchange filing.
Gland Pharma said it is the exclusive first-to-file and is eligible for 180 days of generic drug exclusivity.

As per the IQVIA, the product had US sales of around $171 million for the 12 months ending February 2025.

Gland Pharma shares were trading 0.20% higher at ₹1,415.7 at 2.40 pm on Wednesday, April 30. The stock has declined 21.8% this year, so far.

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