- Reproxalap, an investigational therapy for dry eye disease, received a Complete Response Letter from the FDA.
- Concerns were raised about efficacy and methodologic issues, prompting Aldeyra to plan additional trials.
- The potential NDA resubmission is targeted for mid-year 2025.
- Reproxalap, a RASP modulator, has been studied in over 2,500 patients with no significant safety issues reported.
- The most common adverse event has been mild, transient instillation site irritation.
Source: Aldeyra Press Release
