FDA does not approve reproxalap for dry eye disease
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Key takeaways:
- The FDA issued a complete response letter for reproxalap.
- The rejection is due to a lack of demonstrated efficacy for treating ocular symptoms of dry eye.
The FDA issued a complete response letter regarding the new drug application for reproxalap for the treatment of dry eye disease, according to a press release from Aldeyra Therapeutics.
The letter did not note any issues with safety or manufacturing but stated that the NDA did not demonstrate efficacy for the treatment of ocular symptoms associated with dry eye, according to the release.
The letter said 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,” according to the release.
Aldeyra previously submitted a special protocol assessment to the FDA for a dry eye disease chamber crossover clinical trial, which the company expects to receive feedback for in December. In addition, Aldeyra anticipates an NDA resubmission in the first half of 2024, pending FDA SPA feedback and positive topline results from the proposed trial, according to the release.
“With $143 million in cash, cash equivalents and marketable securities as of September 30, 2023, we are well positioned to conduct another symptom trial of reproxalap in patients with dry eye disease, with a potential NDA resubmission in the first half of 2024,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra Therapeutics, said in the release.
The review period for the resubmission is expected to be 6 months.
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