The FDA has set back Aldeyra Therapeutics’ ambitions to win approval for its dry eye disease, rejecting its second application for approval and calling for data from at least one more study. But with a trial set to read out this quarter, the biotech is aiming to bounce back and resubmit its application in mid-2025.
According to Aldeyra, the FDA found that the submission “failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes.” The shortcoming led the FDA to ask for “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye,” the biotech said.
Aldeyra first filed for FDA approval of reproxalap, a small molecule that binds reactive aldehyde species, in 2022. The company included data from two trials for ocular redness, a sign of dry eye disease, and from two dry eye disease symptom field trials. However, the FDA issued a complete response letter (CRL) and said at least one additional symptom trial was required.
In response, Aldeyra kicked off three trials assessing dry eye disease symptoms: a dry eye chamber trial, a trial in a different dry eye chamber and a six-week field trial. The biotech filed for approval after the first dry eye chamber trial hit its primary endpoint.
However, while Aldeyra’s second submission was bolstered by the chamber trial, the FDA found concerns “with the data from the trial submitted to the NDA that may have affected interpretation of the results,” the biotech said. The CRL raised “methodological issues, including a difference in baseline scores across treatment arms,” according to Aldeyra.
Having initiated multiple studies in response to the first CRL, Aldeyra has outlined a fast path back to the FDA’s door. The biotech expects to meet with the agency within 30 days to discuss the CRL and to share top-line results from the ongoing dry eye disease field trial this quarter. Depending on the discussions and the data, Aldeyra could resubmit for approval in mid-2025 and anticipates a six-month FDA review.