Selection Follows Post-Hoc Analysis Demonstrating Statistical Significance of Reproxalap Over Vehicle in Ocular Redness in Completed TRANQUILITY Trial
LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the designation of Schirmer test, a measure of tear production, as the sole primary endpoint in the Phase 3 TRANQUILITY-2 clinical trial of reproxalap in patients with dry eye disease.
The selection of Schirmer test as the primary endpoint for TRANQUILITY-2 followed Aldeyra’s announcement last week of favorable results of post-hoc analyses from the completed Phase 3 TRANQUILITY and Phase 2 clinical trials of reproxalap in patients with dry eye disease. Using computer automated grading of digital photography, the analyses indicated that reproxalap demonstrated a statistically significant reduction in ocular redness.
“The opportunity to submit a New Drug Application for dry eye disease based on the achievement of two objective signs is significant,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Based on our discussions with ophthalmologists, optometrists, and other key opinion leaders about the unmet medical needs in dry eye disease, ocular redness is a substantial concern for many patients, while Schirmer test has long been considered by many eyecare providers as the benchmark sign endpoint for regulatory approval.”
Christopher E. Starr, M.D., F.A.C.S., Attending Ophthalmologist at New York-Presbyterian Hospital and Associate Professor of Ophthalmology at Weill Cornell Medicine, said, “From a sign approvability standpoint, there is tremendous benefit in having a dry eye disease drug candidate that is capable of reducing ocular redness and enhancing tear production. In that regard, reproxalap has the potential to be highly differentiated from and a welcome addition to current standard-of-care therapies.”
Pending the results from TRANQUILITY-2 and discussion with the U.S. Food and Drug Administration (FDA), Aldeyra intends to submit the Schirmer test results of both TRANQUILITY trials in support of its New Drug Application (NDA) submission. In the TRANQUILITY and TRANQUILITY-2 trials, Schirmer test was assessed after four doses of reproxalap or vehicle over a single day. A secondary endpoint in TRANQUILITY, Schirmer test scores were statistically higher in reproxalap-treated patients (p=0.0001), and the post-hoc proportion of Schirmer test responders of 10mm or greater was statistically higher (p