Aldeyra Therapeutics completes enrollment in part 1 of the phase III GUARD trial of ADX 2191 in proliferative vitreoretinopathy.

The GUARD Trial is a two-part, multi-center, randomized, parallel-group, adaptive Phase III 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 FDA 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.