Dec 27: Mumbai-based drug maker Sun Pharmaceutical Industries Ltd on Wednesday announced 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, it said.
According to Dilip Shanghvi, Managing Director, Sun Pharma, “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.
Abhay Gandhi, CEO – North America Business, Sun Pharma, said, “we hope to bring OTX-101 to patients in the United States as soon as possible, and look forward to working closely with the US FDA over the coming months.”
Sun Pharma shares surged more than 5% to touch a new one month-high of Rs 569.60 on BSE today morning trade, after the news came in. At 10.50 am, the Re 1 face value shares were trading at Rs 569.40, up 5.36% from the previous closing of Rs 540.45.