Aldeyra Therapeutics Shares Fall as Drug Rejected by Regulator on Efficacy Concerns

By Adriano Marchese

Shares of Aldeyra Therapeutics fell sharply in premarket trading Tuesday said the U.S. health regulator rejected its dry-eye drug, saying that the company failed to show the treatment works.

Shares were down 74% to $1.09.

The biotechnology company on Tuesday said it received a complete response letter from the U.S. Food and Drug Administration for its new drug application of reproxalap, which is an investigational drug candidate, to treat dry eye disease.

The FDA said Aldeyra failed to provide substantial, well-controlled evidence that reproxalap works, citing inconsistent trial results and a lack of demonstrated efficacy in treating dry eye disease. The agency also said the data doesn't support the drug's effectiveness, though it raised no safety or manufacturing concerns.

Aldeyra noted that the FDA didn't recommend conducting additional trials or request submission of additional confirmatory evidence.

In the meantime, Aldeyra won't pursue any new clinical trials, but said it plans to meet with the FDA to understand the actions needed for an approval.

Write to Adriano Marchese at adriano.marchese@wsj.com

(END) Dow Jones Newswires

March 17, 2026 09:34 ET (13:34 GMT)