Aldeyra Therapeutics development plans for an NDA for reproxalap in dry eye disease.

Aldeyra Therapeutics, Inc. announced development plans to support a New Drug Application (NDA) for the novel investigational reactive aldehyde species (RASP) inhibitor reproxalap in dry eye disease . Based on FDA meeting minutes, Aldeyra intends to initiate two clinical trials to assess the activity of reproxalap in reducing tear levels of RASP, pro-inflammatory mediators recently accepted by the FDA as an objective sign of dry eye disease.

Top-line results from the first of the RASP trials are expected by the end of 2020, pending potential disruptions due to the COVID-19 pandemic. In addition, a safety trial in dry eye disease patients is expected to be initiated in the fourth quarter of 2020. NDA submission is expected in late 2021.