March 17 (Reuters) – The U.S. Food and Drug Administration declined to approve Aldeyra Therapeutics’ drug for a type of eye disease, the company said on Tuesday, sending its shares plunging over 70% in premarket trading.
The drug, reproxalap, treats dry eye disease (DED), a condition in which the eyes produce insufficient or poor-quality tears, leading to discomfort and potential vision problems.
The FDA, in its so-called complete response letter, said the drug had failed to show enough efficacy for approval. Aldeyra said the regulator raised no concerns about safety or manufacturing.
This marks the third consecutive setback for Aldeyra, which has faced repeated regulatory issues since 2023 related to the drug reproxalap.
The company said it does not currently plan to run additional clinical trials. Instead, it will ask for a Type A meeting with the FDA to discuss what is needed to win approval.
Aldeyra said the FDA advised the company to look into what failed in trials to identify patient groups or conditions where the drug may prove to be effective.
The company added that the agency did not ask for new trials or more confirmatory evidence.
Nearly 16.4 million Americans have DED, with higher prevalence in women and increasing with age, according to the National Institutes of Health.
As of December 31, Aldeyra said it had $70 million in cash, cash equivalents and marketable securities, expected to fund operations into 2028.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Sherry Jacob-Phillips and Devika Syamnath and Maju Samuel)
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