Gland Pharma Gets USFDA Nod For Glaucoma Drug, Secures 180-Day Exclusivity

Gland Pharma Ltd said it has received approval from the US Food and Drug Administration for its abbreviated new drug application for latanoprostene bunod ophthalmic solution, a generic version of Bausch and Lomb Inc.'s Vyzulta.

The drug is used to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

According to an exchange filing, Gland Pharma was the first to file and is eligible for 180 days of generic exclusivity in the US. The product had sales of around $171 million in the 12 months ended February, the company said.