A setback hit Aldeyra Therapeutics IncALDX as the FDA issued a complete response letter, rejecting the company’s New Drug Application (NDA) for reproxalap, an experimental drug for treating dry eye disease.
The rejection cited the NDA’s failure to demonstrate efficacy in treating ocular symptoms associated with dry eyes, requiring at least one additional study to prove its effectiveness. Although no safety or manufacturing issues were found, the letter left the pharmaceutical company disappointed.
In response, Aldeyra has proposed a dry eye disease chamber crossover clinical trial, anticipating a 45-day review cycle following the submission for Special Protocol Assessment (SPA) to the FDA. The company expects feedback in December 2023 and anticipates the trial to cost under $2 million, with top-line results projected for the first half of 2024, subject to FDA approval.
While reproxalap is also in development for allergic conjunctivitis, Aldeyra is extending its cash runway guidance into late 2025. This includes costs related to the proposed trial, potential NDA resubmission, and commercialization plans if reproxalap is approved later in 2024.
The news has taken a toll on the company’s stock, with ALDX shares down 2.29% at $2.5599 at the latest check on Tuesday.
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