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FDA accepts new drug application for Sun dry eye treatment

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The FDA has accepted Sun Pharmaceutical Industries’ new drug application for OTX-101, an aqueous solution intended for treatment of dry eye disease, the company announced in a press release.

OTX-101 is a preservative-free nanomicellar formulation of cyclosporine A 0.09%, which is now under review following positive topline results of a confirmatory phase 3 study. In the 12-week trial, 744 patients with dry eye were treated with OTX-101 or vehicle, and OTX-101 demonstrated “both efficacy and faster onset of action in a trial environment,” Abhay Gandhi, CEO, North America Business, Sun Pharma, said in the release.

Pending FDA approval of OTX-101, commercialization of the product in the U.S. will be done by the company’s wholly owned subsidiary Sun Pharma, which currently markets BromSite (bromfenac ophthalmic solution) 0.075%, according to the release.