Sun Pharmaceutical Industries Ltd said the US FDA has accepted a New Drug Application (NDA) for its OTX-101 dry eye drug. The application will now be processed for approval.
Dry eye is a condition in which the eye does not produce tears properly, or when the tears are not of the correct consistency and evaporate too quickly.
In addition, inflammation of the surface of the eye may occur along with dry eye.
If left untreated, this condition can lead to pain, ulcers, or scars on the cornea, and some loss of vision.
“We are excited about the acceptance of this filing by the US FDA. In January 2017, we had announced positive topline results of confirmatory Phase-3 clinical trial for OTX-101, demonstrating both efficacy and faster onset of action in a trial environment,” said Abhay Gandhi, CEO – North America Business, Sun Pharma.
“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,” said Dilip Shanghvi, Managing Director, Sun Pharma.
The company said the 12-week trial involving 744 dry eye patients showed statistically significant improvement in the primary end point in the trial.
“Based on published data, the efficacy and safety endpoints in these trials compared favorably to other formulations of cyclosporine A with the advantage of faster onset,” the company said.
“The demonstration of efficacy of OTX-101 was earlier than other drugs approved for dry eye in the same class 1 . 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,” Gandhi said.
Dry eye can make it more difficult to perform some activities, such as using a computer or reading for an extended period of time, and it can decrease tolerance for dry environments, such as the air inside an airplane.