Gland Pharma has secured tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application filed for Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC).
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Lumify Ophthalmic Solution, 0.025%, of Bausch & Lomb Inc. It is indicated to relieve redness of the eye.
According to IQVIA, the product had US sales of around $39 million for the twelve months ending September 2025.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
