Aldeyra Therapeutics Announces First Patient Enrolled in the Phase 3 GUARD Trial for Prevention of Proliferative Vitreoretinopathy

Aldeyra Therapeutics announced enrollment of the first patient into the phase 3 GUARD Trial of ADX-2191 for the prevention of proliferative vitreoretinopathy (PVR). PVR is a serious, sight-threatening retinal disease with no approved treatment.

“Initiation of patient enrollment in the GUARD Trial marks an important step toward our goal of improving clinical outcomes for the thousands of patients with this rare but devastating condition,” Todd C. Brady, MD, PhD, President and CEO of Aldeyra, said in a news release. “Today, the only option for patients who develop PVR is surgery, which fails in a significant number of cases. ADX-2191 is a new therapeutic approach with the potential to prevent vision loss from recurrent retinal detachments.”

The GUARD Trial is a two-part, multicenter, randomized, controlled, adaptive phase 3 clinical trial evaluating the efficacy of intravitreal injections of ADX-2191 versus standard-of-care for the prevention of PVR. GUARD will compare recurrent retinal detachment rates over a 24-week period following surgical repair of retinal detachment due to PVR or open globe injury.

In September 2019, the FDA granted fast track designation to ADX-2191 for the prevention of PVR. ADX-2191 has also received orphan drug designation from the FDA for the prevention of PVR.

More information about the GUARD Trial is available on www.clinicaltrials.gov (NCT 04136366).