Aldeyra Therapeutics Plans Submission for Dry Eye Disease Treatment by End of 2022

Aldeyra Therapeutics plans to submit a new drug application (NDA) for the novel dry eye disease treatment reproxalap by the end of 2022. Reproxalap has shown significant clinical results for multiple indications. Aldeyra conducted 5 clinical trials to evaluate reproxalap in more than 2000 patients, none of whom had severe adverse events. In the NDA efficacy package, it is noted that the treatment can be administered short term, or that patients can undergo up to 12 weeks of effective, safe treatment.

“We believe that we have aligned with the FDA on the content of the regulatory package that will support what we expect to be a uniquely comprehensive NDA submission for the treatment of dry eye disease, encompassing data demonstrating improvement that may occur within minutes of drug administration in symptoms and 3 different objective signs,” Todd C. Brady, MD, PhD, Aldeyra’s president and chief executive officer, said in a statement.

Reproxalap is a novel reactive aldehyde species (RASP) modulator. RASP is found at elevated levels in ocular and systemic inflammatory disease. RASP can cause eye redness, change lipid tear composition, decrease the production of tears, and increase ocular inflammation.

Dry eye disease affects more than 39 million US adults each year. Symptoms are characterized by discomfort, dryness, inflammation, irritation, lower quality of life, and pain. Severe cases have led to permanent vision impairment.