Policy & Regulation
Aldeyra Therapeutics Submits New Drug Application to the US Food and Drug Administration for Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease
6 December 2022 - - US-based Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) has submitted a New Drug Application to the US Food and Drug Administration for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease, the company said.

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.

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 range 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.

Reproxalap, an investigational new drug candidate, is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease.

Reproxalap's mechanism of action has been supported by the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications.

Dry eye disease is a common inflammatory disease estimated to affect 39m or more adults in the United States.

The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment.

Among many physicians and patients, existing therapy for dry eye disease is generally regarded as inadequate and often requires weeks or months to demonstrate activity.

In patients with dry eye disease, RASP may contribute to ocular inflammation, diminished tear production, ocular redness, and changes in tear lipid composition.

By diminishing RASP levels, Aldeyra's lead RASP modulator reproxalap represents a novel and differentiated approach for the treatment of the symptoms and signs of dry eye disease.

Aldeyra Therapeutics is a clinical-stage biotechnology company developing innovative therapies designed to treat immune-mediated diseases.