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Aldeyra Therapeutics 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." 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...Top-line results from TRANQUILITY-2 are expected in the second quarter of 2022. Pending discussion with the FDA and enrollment of the ongoing 12-month safety trial of reproxalap in dry eye disease, NDA submission for dry eye disease is expected to occur mid-2022.

Aldeyra reported that a post-hoc analysis using computer automated grading of digital photography from the completed Phase 3 TRANQUILITY dry eye chamber trial demonstrated statistical significance in favor of reproxalap over vehicle for the primary endpoint of reduction of ocular redness. As previously announced, the Phase 3 TRANQUILITY trial failed to meet the primary endpoint of ocular redness as assessed by independent central reviewers. When applied to Aldeyra's Phase 2 dry eye chamber trial, which was completed in late 2021, the computer automated grading assessment confirmed the previously announced achievement of the primary endpoint of ocular redness, which, similar to the Phase 3 TRANQUILITY trial, was originally assessed by independent central reviewers. Aldeyra intends to discuss the results of the post-hoc analyses, as well as the algorithm used for the computer automated assessment of ocular redness,1 with the FDA prior to NDA submission. The computer automated grading of redness in the completed Phase 3 TRANQUILITY and Phase 2 clinical trials of reproxalap is based on digital images captured by portable cameras fitted with eye cups to standardize distance, lighting, focus, hue, and contrast. The assessment consisted of automated selection of temporal conjunctiva from images of subjects focusing on nasal targets in the eye cup. Redness intensity was averaged across all pixels in the selected region, and combined with vessel geometry to generate a theoretical maximum score of 255. The average baseline score from the post-hoc analyses of the Phase 3 TRANQUILITY and Phase 2 clinical trials was approximately 18. Per draft FDA guidance, to be considered for regulatory approval in the United States, a product candidate for the treatment of dry eye disease must, with certain exceptions, demonstrate efficacy in an objective sign in at least two clinical trials and efficacy in a subjective symptom in at least two clinical trials. Statistical significance versus vehicle is generally considered sufficient for demonstration of efficacy. For satisfaction of symptom efficacy requirements, Aldeyra intends to submit two previously completed adequate and well-controlled 12-week symptom trials that pre-specified patient-reported ocular dryness score as a primary endpoint, the Phase 3 RENEW-Part 1 and Formulation Phase 2 clinical trials. Pending discussion with the FDA, for satisfaction of the sign efficacy requirements, Aldeyra intends to submit the ocular redness results from the Phase 3 TRANQUILITY and Phase 2 dry eye chamber trials. If the primary endpoint of Schirmer test is achieved in the Phase 3 TRANQUILITY-2 trial, and pending discussion with the FDA, Aldeyra intends to submit Schirmer test results from both TRANQUILITY trials as evidence for achievement of an additional objective sign of dry eye disease. Top-line results from TRANQUILITY-2 are expected in the second quarter of 2022. Pending discussion with the FDA and enrollment of the ongoing 12-month safety trial in dry eye disease patients, NDA submission for dry eye disease is expected to occur mid-2022.

Omega Therapeutics (OMGA) announced the appointment of Joshua Reed as CFO, effective May 23, 2022. Roger Sawhney, M.D., Omega's CFO, will serve as Chief Business Officer. Reed most recently served as Chief Financial Officer of Aldeyra Therapeutics (ALDX).

Aldeyra Therapeutics "announced that CFO and Treasurer Joshua Reed tendered his resignation to pursue other career opportunities. Mr. Reed will continue to serve as CFO and Treasurer until May 10, 2022 to assist with the transition of his responsibilities and to participate in Aldeyra's upcoming earnings conference call to discuss its financial results for the quarter ended March 31, 2022. Effective as of the Resignation Date, Aldeyra plans to appoint its current Vice President and Controller, Bruce Greenberg, CPA to serve as its Vice President of Finance, Interim CFO, and Treasurer."