Aldeyra Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its drug ADX-2191, intended for the treatment of retinitis pigmentosa. This designation is set to expedite the development and review process of ADX-2191, which has shown promising results in a Phase 2 clinical trial by improving retinal sensitivity. Retinitis pigmentosa, a severe genetic eye disease, currently lacks approved therapies for most forms. The Fast Track Designation, along with a previously announced Orphan Drug Designation, highlights the potential of ADX-2191 to meet a significant unmet need in ophthalmology. A Phase 2/3 clinical trial is anticipated to begin in 2025.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aldeyra Therapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250819317013) on August 19, 2025, and is solely responsible for the information contained therein.