Aldeyra Therapeutics Reports Results from Phase 3 TRANQUIITY Trial in Dry Eye Disease

Dec 21, 2021 By MarketDepth

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Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) reported topline results from its Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution, an investigational product candidate to treat dry eye disease.  “Following the achievement of statistical significance in ocular redness in our recent Phase 2 clinical trial, the achievement of statistical significance of Schirmer test in TRANQUILITY may provide an additional option to satisfy the remaining objective sign requirement for dry eye disease NDA submission,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “Subject to agreement with the FDA, we believe that the TRANQUILITY results allow for the possibility that, pending the outcome of TRANQUILITY-2, the NDA submission for reproxalap could represent the first time a dry eye disease drug will have qualified for the demonstration of activity for two objective signs.”

“Notwithstanding the inherent variability of dry eye disease clinical trials, our investigational product candidate 0.25% reproxalap has now demonstrated activity in four late-stage clinical trials with the intended commercial dosing regimen. We continue to advance reproxalap toward NDA submission as we focus on the completion of TRANQUILITY-2 and enrollment in the 12-month safety trial.”

Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra