Top-line results are expected during second quarter for the therapeutic to treat patients with dry eye disease.
Aldeyra today announced completion of enrollment in the Phase 3 TRANQUILITY-2 Trial of 0.25% reproxalap ophthalmic solution (reproxalap) in patients with dry eye disease.
According to the company, the multi-center, double-masked, parallel-group TRANQUILITY-2 Trial (NCT05062330) enrolled 361 patients randomly assigned to receive either reproxalap or vehicle over two days. On the first day, patients received four doses, and Schirmer testing (a measure of tear volume) was performed before and after the fourth dose. On the second day, doses were administered just prior to and at the mid-point of a 90-minute dry eye chamber with minimal humidity, high airflow, and forced visual tasking.
The primary endpoints of the TRANQUILITY-2 Trial are Schirmer test on the first day of dosing and ocular redness on the second day of dosing during the dry eye chamber. Top-line results from the trial are expected to be announced this quarter.
The company noted that based on the results of the previously completed Phase 2 and TRANQUILITY clinical trials, TRANQUILITY-2 is at least 90% powered to detect a statistically significant difference in Schirmer test or ocular redness endpoints. If successful in meeting one of the primary endpoints, TRANQUILITY-2 could complete New Drug Application (NDA) submission requirements for demonstration of improvement in an objective sign of dry eye disease.
According to draft U.S. Food and Drug Administration (FDA) guidance, to be considered for regulatory approval in the United States, a product candidate for the treatment of dry eye disease must demonstrate efficacy in an objective sign in at least two clinical trials and efficacy in a subjective symptom in at least two clinical trials. To satisfy the symptom efficacy requirements, Aldeyra intends to submit two previously completed 12-week adequate and well-controlled symptom trials that pre-specified patient-reported ocular dryness score as a primary endpoint, the Phase 3 RENEW-Part 1 Trial and the Formulation Phase 2 clinical trial.
Aldeyra’s previously announced Phase 2 clinical trial achieved the primary endpoint of ocular redness, an approvable sign of dry eye disease. Pending discussion with the FDA and the results of TRANQUILITY-2, Aldeyra may submit 2 pivotal trials for either ocular redness (Phase 2 and TRANQUILITY-2) or Schirmer test (TRANQUILITY and TRANQUILITY-2), or two trials for both signs (Phase 2, TRANQUILITY, and TRANQUILITY-2) if ocular redness and Schirmer test are achieved in TRANQUILITY-2. Either Phase 2 or Phase 3 clinical trials can be submitted as pivotal, provided that the trials are adequate and well-controlled.
Pending enrollment of the ongoing 12-month safety trial of reproxalap in dry eye disease patients and the outcome of TRANQUILITY-2, Aldeyra’s dry eye disease NDA submission is expected to occur mid-2022.