Aldeyra Therapeutics has announced the completion of subject enrollment in its Phase III clinical trial of topical ocular 0.25% reproxalap for the treatment of dry eye disease. The trial, which enrolled a total of 132 subjects, aims to evaluate the primary endpoint of ocular discomfort. The results are intended to support a potential resubmission of a New Drug Application (NDA) to the FDA in the second half of 2024.
The Phase III trial is designed as a dry eye chamber study. This approach is intended to provide controlled environmental conditions to assess the efficacy of reproxalap in alleviating dry eye symptoms. Aldeyra's decision to conduct this trial follows a Complete Response Letter (CRL) issued by the FDA in November of the previous year, which requested additional clinical trial data to demonstrate the drug’s efficacy.
Prior Clinical Evidence
Reproxalap has demonstrated promising results in previous studies. An analysis of combined data from four completed dry eye chamber clinical trials showed that the treatment led to a statistically significant reduction in ocular discomfort compared to a vehicle. These findings provide a foundation for the current Phase III trial and the planned NDA resubmission.
Proposed Label and Potential Impact
Aldeyra plans to propose a draft label in the NDA resubmission for reproxalap that highlights both chronic and acute symptom improvement, as well as a reduction in ocular redness. If approved, this label could be the first for a dry eye disease treatment to include clinical data from an acute setting in a dry eye chamber and to feature ocular redness reduction for a chronically administered medication. This label expansion could significantly broaden the drug's appeal and utility in clinical practice.
Ongoing Studies and Future Plans
In addition to the completed enrollment in this Phase III trial, Aldeyra is conducting a separate Phase III trial in a different dry eye chamber and a standard six-week field clinical trial. These concurrent studies are part of a comprehensive strategy to address the variability in disease presentation and potential disparities in clinical site environments. According to Aldeyra Therapeutics president and CEO Todd Brady, the company anticipates receiving results from the clinical trial in the third quarter of 2024 and remains on track to resubmit the dry eye disease NDA for reproxalap in the second half of 2024, contingent on positive results.
The FDA has indicated that the review period for the potential NDA resubmission should last six months. If approved, reproxalap could offer a new treatment option for the millions of patients suffering from dry eye disease.
