Aldeyra Therapeutics received Fast Track Designation from the FDA for ADX-2191 to treat retinitis pigmentosa, a rare genetic eye disease.
There is currently no approved treatment for most forms of retinitis pigmentosa affecting over one million people worldwide.
Fast Track Designation highlights the potential of ADX-2191 to address the unmet medical need in ophthalmology.
Fast Track Designation Granted
The FDA granted Fast Track Designation for ADX-2191, emphasizing its potential to treat retinitis pigmentosa effectively.
Encouraging Phase 2 Results
Results from a Phase 2 clinical trial in 2023 showed improvements in retinal sensitivity after ADX-2191 treatment.
Upcoming Phase 2/3 Trial
A Phase 2/3 clinical trial for ADX-2191 in retinitis pigmentosa is set to commence in 2025.
- Fast Track Designation accelerates drug development and review for serious conditions like retinitis pigmentosa.
- ADX-2191's potential to improve retinal sensitivity offers hope for patients with this progressive eye disease.
Aldeyra's Fast Track Designation for ADX-2191 underscores the urgency in finding effective treatments for retinitis pigmentosa, bringing hope to patients worldwide.