Aldeyra Therapeutics announced submission of a new drug application (NDA) to the FDA for 0.25% topical ocular reproxalap to treat dry eye disease (DED).

What is reproxalap?

Reproxalap is a reactive aldehyde species (RASP) inhibitor. RASP can cause decreased tear production, eye redness, change lipid tear composition, and increase ocular inflammation.

How did it perform in clinical trials?

Recent study data includes a phase 2b trial where reproxalap achieved its primary endpoint, demonstrating significant improvements in symptoms such as dryness, grittiness, stinging, and burning, and sign measures such as Schirmer’s test, tear break-up time, osmolarity, fluorescein staining. (via)

A phase 3 trial also met its primary endpoint and was significantly superior for its two pre-specified endpoints: Schirmer’s test (p=0.0001) and  ≥10 mm Schirmer test responder proportions (p<0.0001) after a single day of dosing. (via)

How quickly can reproxalap work?

According to studies, reproxalap can show signs of activity ranging from within minutes of administration to up to 12 weeks.

Any adverse reactions across all five studies?

Topical ocular reproxalap has been studied in more than 2,000 patients with no observed clinically significant safety concerns. The most commonly reported adverse event was mild and brief site installation irritation.

What’s next?

Stay tuned! The FDA now has 60 days to consider the application for review. If accepted, a Prescription Drug User Fee Act (PDUFA) may come late next summer.