Aldeyra Therapeutics (ALDX) Study Update summary

Study background and design

• Phase 3 trial for reproxalap in dry eye disease was randomized, double-masked, vehicle-controlled, enrolling 132 patients equally into reproxalap and vehicle arms.

• The dry eye chamber simulated low-humidity environments to provoke symptoms, with acute assessment over 100 minutes.

• Ocular discomfort, measured on a 0–100 scale from 80–100 minutes post-chamber entry, was the sole primary endpoint, accepted by the FDA.

• Trial protocol and statistical plan were developed with FDA feedback and Special Protocol Assessment.

• Vehicle run-in excluded patients who did not escalate in discomfort, ensuring robust randomization.

Key results and efficacy

• Reproxalap achieved statistical superiority over vehicle for the primary endpoint, with a p-value of 0.004.

• Change from baseline in discomfort was about 75% less in the reproxalap group compared to vehicle.

• Rapid and sustained symptom improvement, including acute reduction of ocular redness, was observed.

• Symptom improvements were consistent with previous field trial results reviewed by the FDA.

• No secondary or exploratory endpoints were assessed, focusing analysis on the primary endpoint.

Safety and tolerability

• No safety concerns identified; reproxalap was well-tolerated with only mild, transient instillation site irritation.

• No trial discontinuations due to adverse events.

• Reproxalap has been studied in over 2,500 patients with a consistent safety profile.