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Reproxalap

Dry Eye Disease (Signs & Symptoms)

Phase 3NDA Submitted; Received CRL Mar 2026

Key Facts

Indication
Dry Eye Disease (Signs & Symptoms)
Phase
Phase 3
Status
NDA Submitted; Received CRL Mar 2026
Company

About Aldeyra Therapeutics

Aldeyra Therapeutics is devoted to developing next-generation medicines for immune-mediated diseases through its innovative RASP modulator platform, which targets a family of pathogenic small molecules rather than single proteins. The company's most advanced candidate, reproxalap, has demonstrated rapid activity in multiple late-stage trials for dry eye disease, though it recently received a Complete Response Letter from the FDA. Aldeyra is also developing ADX-2191, an intraocular formulation of methotrexate with Orphan Drug Designation for rare retinal conditions, and ADX-629, an oral RASP modulator for systemic diseases, positioning it to address significant unmet needs across ophthalmology and immunology.

View full company profile

About Aldeyra Therapeutics

Aldeyra Therapeutics is devoted to developing next-generation medicines for immune-mediated diseases through its innovative RASP modulator platform, which targets a family of pathogenic small molecules rather than single proteins. The company's most advanced candidate, reproxalap, has demonstrated rapid activity in multiple late-stage trials for dry eye disease, though it recently received a Complete Response Letter from the FDA. Aldeyra is also developing ADX-2191, an intraocular formulation of methotrexate with Orphan Drug Designation for rare retinal conditions, and ADX-629, an oral RASP modulator for systemic diseases, positioning it to address significant unmet needs across ophthalmology and immunology.

View full company profile