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Sun Pharmaceutical Industries Ltd. said the U.S. Food and Drug Administration accepted its new drug application for Seciera, a treatment for the dry eye disease.
The treatment, a clear aqueous solution, is now under review for approval by the regulator.
Once approved, Sun Pharma plans to commercialize Seciera in the U.S. through its subsidiary Sun Ophthalmics Inc.
Seciera, also known as OTX-101, previously met its main and secondary goals in a phase 3 trial in patients with the disease.