FDA accepts investigational new drug application for dry eye drop

The U.S. Food and Drug Administration (FDA) accepted an investigational new drug application for AR-15512 (Aerie Pharmaceuticals, Inc) for dry eye. AR-15512 regulates tear production and blink rate.

“The acceptance of the IND for AR-15512 marks the first clinical-stage dry eye product candidate for Aerie, another important milestone for the company. We expect to commence a Phase 2b clinical study, which will be powered as a Phase 3, later this year, with a topline readout expected in the third quarter of 2021,” said Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, in a press release.

Read the full press release here.