Published: December 2023
On 27 November 2023, Ldeyra Therapeutics announced the reception of a Complete Response Letter from FDA regarding the New Drug Application (NDA) for reproxalap, an investigational drug intended for dry eye disease treatment. While no safety or manufacturing concerns were identified with reproxalap, the FDA indicated in the letter a lack of demonstrated "efficacy in treating ocular symptoms associated with dry eyes." They suggested the necessity for "at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye," as per the draft FDA guidance on dry eye disease, which may require two symptom trials and two sign trials to establish efficacy.
Aldeyra had previously conducted two trials focused on ocular redness and a trial specifically targeting dry eye disease symptoms. On November 16, 2023, Aldeyra submitted a Special Protocol Assessment (SPA) to the FDA for a dry eye disease chamber crossover clinical trial (the proposed trial), resembling the crossover chamber trial for which Aldeyra had announced results on July 12, 2022. The SPA review cycle is expected to be 45 days, and Aldeyra anticipates FDA feedback by December 2023. The proposed trial is projected to cost under $2 million, with top-line results estimated in the first half of 2024, contingent upon FDA feedback on the SPA. Subsequent to positive outcomes from the proposed trial and FDA SPA feedback, Aldeyra anticipates potentially resubmitting the NDA in the first half of 2024. The intended NDA resubmission is expected to encompass a preliminary label outlining both chronic and acute symptomatic benefits, in addition to acute reduction in ocular redness resulting from reproxalap.
According to Roots Analysis, the Dry Eye Diseases Market is anticipated to grow at a stable rate during the forecast period.
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