Aldeyra Therapeutics, Inc. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease.
The NDA submission is supported by safety and efficacy data from five adequate and well-controlled clinical trials encompassing data for ocular dryness symptom score, ocular redness, Schirmer test, and Schirmer test ≥10 mm responder analysis. The regulatory package includes activity ranging from within minutes of drug administration to up to 12 weeks of treatment, crossover and parallel-group clinical trial designs, and assessment in dry eye chamber challenge and natural environment settings. Topical ocular reproxalap has been studied in more than 2,000 patients with no observed clinically significant safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials.
“The NDA submission for reproxalap is, to our knowledge, the most comprehensive regulatory package ever for a dry eye disease drug candidate,” stated Todd C. Brady, M.D., Ph.D., Aldeyra’s President and Chief Executive Officer. “With data suggesting activity within minutes of administration, reproxalap could provide an important treatment option for the millions of dry eye patients who generally regard currently available therapies as inadequate.”
If approved, reproxalap would be the first marketed RASP (reactive aldehyde species) modulator, representing a novel, systems-based pharmacology involving a family of small molecule targets that affect a broad array of protein mediators. Reproxalap is the lead product candidate in Aldeyra’s RASP modulator platform, which includes systemic disease pipeline candidates ADX-629 and related analogs. ADX-629, which successfully completed proof-of-concept trials in psoriasis, asthma, and COVID-19, is currently in Phase 2 clinical trials for chronic cough, alcoholic hepatitis, minimal change disease, and Sjögren-Larsson Syndrome. Top-line results in alcoholic hepatitis are expected by the end of 2022.
In addition to dry eye disease, reproxalap is in late-stage development for allergic conjunctivitis, a condition that is commonly associated with dry eye disease. Results of the Phase 3 INVIGORATE-2 Trial are expected in 2023.