Previously, the Company had received CRLs in November 2023 and April 2025 due to insufficient evidence in addressing the ...

Aldeyra Therapeutics Inc. ALDX shares are tumbling on Tuesday following the U.S. Food and Drug Administration (FDA) update.

After delaying its review, the FDA has rejected Aldeyra Therapeutics’ experimental dry eye disease treatment for the third time. | After delaying its review, the FDA has rejected Aldeyra Therapeutics’ ...

In its complete response letter, the FDA said Aldeyra had failed to demonstrate reproxalap’s efficacy in adequate and ...

The US Food and Drug Administration (FDA) has issued a Complete Response Letter to Aldeyra Therapeutics for its New Drug Application of reproxalap for the treatment of dry eye dis ...

FDA rejection was attributed to a lack of substantial evidence of efficacy, including inconsistencies that undermined confidence in reproducibility across investigations. Reproxalap targets reactive ...

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.

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced ...

Study reveals that 77% of patients with moderate-to-severe dry eye disease exhibit discordance between clinical signs and symptoms.

Watery eyes become increasingly common after 50, even if you have dealt with dry eyes. Alexander Martin, Doctor of Optometry, ...

MFDS IND approval enables a multicenter, randomized, double-blind, vehicle-controlled phase 2 study in ~150 DED patients, randomized 1:1:1 to two dosing arms versus control over 12 weeks. Prior phase ...

A new interpretation of a 3,500-year-old medical text from Egypt suggests that ancient physicians might have bathed patients’ ...