FDA Rejects Aldeyra Therapeutics' Dry Eye Disease Candidate, Asks For Additional Study

The FDA issued a complete response letter to Aldeyra Therapeutics Inc's ALDX New Drug Application (NDA) of reproxalap, an investigational drug candidate for dry eye disease. 

Although no safety or manufacturing issues with reproxalap were identified, the FDA stated in the letter that the NDA did not demonstrate "efficacy in treating ocular symptoms associated with dry eyes" and that "at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye" should be conducted.

In November, Aldeyra submitted a Special Protocol Assessment (SPA) to the FDA for a dry eye disease chamber crossover clinical trial (the proposed trial) similar to the crossover chamber trial from which Aldeyra announced results in July last year.

The SPA review cycle is anticipated to be 45 days, and Aldeyra expects FDA feedback from the SPA in December of 2023. The proposed trial is expected to cost less than $2 million, and top-line results are anticipated in the first half of 2024, subject to FDA feedback.

Reproxalap is also under development for allergic conjunctivitis. Aldeyra plans to conduct a Type C meeting with the FDA in the first half of 2024 to discuss the potential NDA submission.

Aldeyra is extending previous cash runway guidance into late 2025, including clinical trial costs associated with the proposed trial and potential NDA resubmission, as well as the initial commercialization and launch plans for reproxalap, if approved in late 2024.

Price Action: ALDX shares are down 2.29% at $2.5599 on the last check Tuesday.

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