US FDA Declines to Approve Aldeyra’s Eye Disease Drug

(Reuters) -The U.S. Food and Drug Administration has once again declined to approve Aldeyra Therapeutics treatment for dry eye disease, the company said on Thursday, sending its shares down 73% premarket.

In its complete response letter, the FDA said the application for the drug, reproxalap, failed to demonstrate efficacy and requested the company to conduct at least one additional trial to show a positive effect of the treatment.

This marks the second consecutive setback for reproxalap, as the drug once again faces the need for an additional trial from the FDA, following a similar request in 2023 when it failed to secure marketing approval.

The health regulator’s decision was based on a late-stage trial with 132 patients where the drug was tested to reduce symptoms of ocular discomfort, an unpleasant sensation in the eyes.

The company said it has two ongoing trials for the drug, and plans to resubmit its marketing application mid-year, pending positive results and discussions with the FDA.

Aldeyra partners with AbbVie on reproxalap with AbbVie having the option to acquire a co-exclusive license to develop, manufacture and commercialize the drug in the U.S.

Dry eye disease (DED) is a condition where the eyes don’t produce enough tears or poor-quality tears, leading to discomfort and potentially vision problems.

Nearly 16.4 million Americans have DED, with higher prevalence in women and increasing with age, according to the National Institutes of Health.

Other FDA-approved treatments for DED include Alcon’s Eysuvis and Bausch + Lomb’s Xiidra.

(Reporting by Christy Santhosh and Padmanabhan Ananthan in Bengaluru; Editing by Vijay Kishore)