" class="no-js "lang="en-US"> Aldeyra Announces Enrollment of Retinitis Pigmentosa Clinical Trial
Saturday, April 01, 2023

Aldeyra Therapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial of ADX‑2191 in Retinitis Pigmentosa

Aldeyra Therapeutics today announced the completion of enrollment in the Phase 2 clinical trial of ADX‑2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of retinitis pigmentosa, a group of rare genetic eye diseases characterized by retinal cell death and loss of vision, for which there is no U.S. Food and Drug Administration (FDA)-approved treatment.

The open-label, single-center Phase 2 clinical trial enrolled a total of eight retinitis pigmentosa patients with rhodopsin gene mutations, including the P23H gene mutation. Patients receive either monthly or twice-monthly intravitreal doses of ADX‑2191 for three months. The primary endpoint of the trial is safety. Secondary endpoints include change from baseline in visual acuity; retinal function, as assessed by foveal microperimetry, electroretinography, and dark adaptation; and retinal morphology, as assessed by optical coherence tomography.

“Given the lack of FDA-approved therapies for retinitis pigmentosa, a sight-threatening group of diseases that affect more than one million patients worldwide, novel therapeutic approaches are in demand,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “Aldeyra is committed to working with patients and physicians to attempt to ameliorate the unrelenting burden of retinitis pigmentosa, and we look forward to reporting top-line results of the Phase 2 clinical trial in the first half of this year.”

  1. Insmed Completes Enrollment of Adult Patients in Phase 3 ASPEN Study of Brensocatib in Bronchiectasis Read more
  2. NEC Establishes Subsidiaries in Europe for Strengthening Global AI Drug Development Business Read more
  3. Flare Therapeutics Further Strengthens Leadership Team with Key Executive Appointments and Promotions Read more
  4. Sensorion Appoints Khalil Barrage as Interim Chairman of the Board Read more
  5. Ablaze Pharmaceuticals Plans Development of Innovative GPC3 Targeted Radiopharmaceutical Therapy for Liver Cancer in Greater China Read more