Aldeyra's Dry Eye Drug Shows Mixed Results in Phase 3 Trials, Plans FDA Resubmission

Aldeyra Therapeutics has announced top-line results from two phase 3 trials of its dry eye disease drug candidate, reproxalap, setting the stage for a potential FDA resubmission later this year. The company, which has faced two previous rejections from the regulatory agency, is banking on these latest results to support its case for approval.

Positive Outcome in Dry Eye Chamber Trial

The first phase 3 study, a dry eye chamber trial, met its primary endpoint with reproxalap demonstrating statistically superior performance compared to the control in reducing ocular discomfort. This positive outcome addresses one of the FDA's key concerns from previous submissions and could potentially strengthen Aldeyra's position in its upcoming regulatory filing.

Todd Brady, M.D., Ph.D., CEO of Aldeyra, highlighted the advantages of including dry eye chamber data in the drug's label, stating, "I think our label would be compelling with either an additional field trial or a dry eye symptom trial from a dry eye chamber on the label."

Mixed Results from Field Trial

In contrast to the chamber trial's success, a concurrent field trial of reproxalap failed to reach statistical significance on its primary endpoint. Aldeyra reported that while the results were "numerically supportive of reproxalap and consistent with prior field trials," they fell short of demonstrating a statistically significant improvement over the control.

Despite this setback, the company maintains that the field trial data can still contribute to its FDA resubmission package. Aldeyra emphasized that there were "no notable differences in baseline scores across treatment arms" in the second dry eye chamber trial, potentially addressing previous FDA concerns about baseline differences in earlier studies.

Regulatory Strategy and Timeline

Aldeyra plans to resubmit its New Drug Application (NDA) for reproxalap to the FDA in mid-2025. The company anticipates a six-month review period, which could position reproxalap for potential approval by late 2025 or early 2026, pending a favorable FDA decision.

The upcoming submission will include data from both the successful dry eye chamber trial and the recently completed field trial. This strategy aligns with draft FDA guidance, which states that both chamber trials and traditional environmental exposure studies can be acceptable in dry eye disease filings.

As Aldeyra prepares for its third attempt at FDA approval, the pharmaceutical industry will be closely watching to see if the company's persistence and refined clinical data package will finally secure reproxalap's place in the dry eye disease treatment landscape.