Gland Pharma, a pharmaceutical company specializing in generic injectables, has secured approval from the United States Food and Drug Administration (FDA) for Latanoprost Ophthalmic Solution, 0.005% (2.5 mL Fill). This approval marks a significant step for Gland Pharma in expanding its presence in the US ophthalmic market.
The approved Latanoprost Ophthalmic Solution is bioequivalent and therapeutically equivalent to Xalatan (latanoprost ophthalmic solution 0.005%), held by UPJOHN US 2 LLC. Latanoprost is a prostaglandin analog used to manage intraocular pressure.
Clinical Indication and Market Opportunity
The ophthalmic solution is indicated for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Glaucoma is a progressive optic neuropathy that can lead to irreversible vision loss, often associated with elevated IOP. Ocular hypertension is defined as elevated IOP without optic nerve damage or visual field loss. Lowering IOP is a key strategy in managing these conditions.
Gland Pharma plans to launch Latanoprost Ophthalmic Solution through its marketing partners in fiscal year 2025. According to IQVIA data, the US market for this product had sales of approximately $111.6 million for the twelve months ending December 2023.
Gland Pharma's Expanding Portfolio
Established in 1978 and based in Hyderabad, India, Gland Pharma has evolved into a major player in sterile injectables. The company operates on a business-to-business model, with a global presence in 60 countries. This FDA approval is expected to further strengthen Gland Pharma's position in the US pharmaceutical market.
