Benzinga | Jan 4, 2022 08:11AM EST

Aldeyra Therapeutics Reports Completion Of Enrollment In Phase 1 Of Phase 3 GUARD Trial Of ADX-2191 In Proliferative Vitreoretinopathy

Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a biotechnology company discovering and developing innovative therapies for the treatment of immune-mediated diseases, today announced completion of enrollment in Part 1 of the Phase 3 GUARD Trial of ADX-2191 (intravitreal methotrexate 0.8%) in patients with proliferative vitreoretinopathy (PVR), a rare, sight-threatening ocular disease with no approved therapy.

The GUARD Trial is a two-part, multi-center, randomized, parallel-group, adaptive Phase 3 clinical trial evaluating the efficacy of intravitreal injections of ADX-2191 versus standard of care (routine monitoring) for the prevention of PVR following retinal detachment repair. The primary endpoint is recurrent retinal detachment rates over a 24-week post-operative period. Part 1 of the GUARD Trial, which enrolled 110 patients, is being conducted in the United States. Top-line results from Part 1 are expected in the second half of 2022.

"ADX-2191 has the potential to become the first drug in the U.S. indicated for the prevention of PVR, a sight-threatening condition for which there is no approved treatment," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "Clinical results suggest that methotrexate, the active ingredient of ADX-2191, may diminish the rates of retinal detachment and improve visual outcomes in thousands of patients who undergo surgery for PVR."

ADX-2191, a vitreous-compatible formulation of methotrexate, has been granted fast track and orphan drug designation by the U.S. Food and Drug Administration for the prevention of PVR. Fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions, potentially accelerating patient access to new therapies. Orphan drug designation qualifies sponsors for incentives including tax credits for qualified clinical trials; exemption from user fees; and market exclusivity after approval, if received.