- 02 May 2025
- ICICIdirect Research
GLAND PHARMA HAS RECEIVED AN APPROVAL FOR LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION FROM THE USFDA
News: Gland Pharma has received an approval for Latanoprostene Bunod Ophthalmic Solution from the USFDA. This product is therapeutically equivalent to Vyzulta Opthalmic Solution, of Bausch and Lomb, inc. The product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Since Gland is the exclusive First-to-File hence is eligible for 180 days generic exclusivity. According to IQVIA, the product had US sales of approximately US$ 171 million for the twelve months ending February 2025.
View: Gland Pharma is an exclusive first to file for Latanoprostene Bunod Ophthalmic Solution and therefore in eligible for 180 days generic exclusivity. We believe, with the market size of US$ 171 million; 180 days exclusivity and no other generic player present (as of now) would help Gland to improve its margins.
Impact: Positive