Iryna Drozd
The FDA has refused to approve Aldeyra Therapeutics (NASDAQ:ALDX) drug reproxalap, citing insufficient evidence that the drug was effective in treating the ocular symptoms of dry eye disease.
Aldeyra said the agency issued a complete response letter for his medication. application, stating that the company needed to conduct “at least one additional adequate and well-controlled study to demonstrate a positive effect in the treatment of ocular symptoms of dry eye.”
The agency was expected to make a decision on whether to approve the dry eye drug by Nov. 23.
Aldeyra said it submitted a Special Protocol Assessment, or SPA, to the FDA for the proposed trial on Nov. 16 and expects comments from the agency on the matter in December. The proposed trial is expected to cost less than $2 million and topline results are anticipated during the first half of 2024, subject to FDA comments on the SPA.
Pending positive feedback from the SPA, Aldeyra hopes to resubmit its new drug application for reproxalap in the first half of 2024. The FDA is expected to issue a decision in six months.
Aldeyra said it was “well positioned” to conduct another study, with a possible resubmission of the application in the first half of 2024, adding that it had $143 million in cash and equivalents as of September 30. She added that she has extended the cash trail. guidance until the end of 2025, according to its current operating plan.
Reproxalap is also being developed for the treatment of allergic conjunctivitis. The company plans to hold a Type C meeting with the FDA in the first half of 2024 to discuss a potential NDA submission for the product for that indication. Results from a Phase 3 study of the drug for allergic conjunctivitis were announced in June.
(Updates headline).
