Sun Pharma Announces US FDA Acceptance of NDA for OTX-101

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OTX-101 is being evaluated for treatment of dry eye disease

 

Mumbai : Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO,Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) announces that the US FDA has accepted a New Drug Application (NDA), filed by its wholly owned subsidiary, for OTX-101 (cyclosporine A, ophthalmic solution) 0.09%, a novel nanomicellar formulation of cyclosporine A 0.09% in a clear, preservative-free aqueous solution. OTX-101 is now under review for approval by the US FDA, marking an important developmental milestone for Sun Pharma’s dry eye candidate.

Dilip Shanghvi, Managing Director, Sun Pharma, said: “Dry Eye disease is a complex, chronic condition that affects patient quality of life, often significantly. OTX-101, a novel formulation of cyclosporine, will allow us to participate in the rapidly growing underserved and dynamic Dry Eye market. When approved, it will be a milestone for millions of Dry Eye patients across the globe that are yet to find relief for their condition.”

Post the US FDA approval, OTX-101 will be commercialized in the US by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary, based in Princeton, New Jersey. Sun Ophthalmics, founded in 2015, currently markets BromSite® (bromfenac ophthalmic solution) 0.075% to eye care practitioners across US

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