Aldeyra Therapeutics just submitted an NDA to the FDA for reproxalap, an investigational new drug candidate for the signs and symptoms of dry eye disease.
Tell me more about reproxalap.
Reproxalap is a reactive aldehyde species (RASP) inhibitor. RASP are reactive molecules that bind to cellular biomolecules, disrupting their function and activating proinflammatory mediators. RASP are found to be elevated in ocular and systemic inflammatory disease and present a novel antiinflammatory target.
How quickly can this new drug work?
According to studies, reproxalap can show signs of activity ranging from within minutes of administration to up to 12 weeks.
Are there any side effects?
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.
When will we hear more?
Assuming the FDA accepts the NDA submission, we will likely hear more late next year. (via)