Clinical trial update for rare proliferative ocular diseases presented at meeting
During a presentation at the virtual World Orphan Drug Congress USA 2020, Todd C. Brady, MD, PhD, the CEO of Aldeyra Therapeutics, discussed the GUARD trial which is evaluating the efficacy of intravitreal ADX-2191 injections for the prevention of recurrent retinal detachment due to proliferative vitreoretinopathy (PVR).
Proliferative vitreoretinopathy is a rare disease effecting approximately 4000 in the United States and is the leading cause of failure of retinal detachment surgery.
“Surgery itself is fairly successful at reattaching the retina to the back of the eye,” said Dr Brady. “The challenge is really the scarring as the result of the procedure. About 50% of PVR cases result in severe vision loss and 76% of PVR cases suffer from some form of vision loss.”
Approximately 10% of retinal attachment surgeries results in PVR, said Dr Brady, with it being a particular concern for ocular traumas.
In the 2-part, multi-center, randomized, controlled, adaptive Phase 3 clinical trial, 50 patients treated with ADX-2191 in addition to routine surgical care are being compared to 50 patients treated with routine surgical care alone.
Dr Brady said he hopes a progress update on the GUARD clinical trial will be available by the end of 2020.
ADX-2191 has received orphan drug designation and fast track designation from the U.S. Food and Drug Administration.
In addition to PVR, additional indications for ADX-2191 are being explored, including for primary intraocular lymphoma.
Primary vitreoretinal lymphoma is a rare, aggressive high-grade cancer that effects just under 3K patients in the United states. The median survival for newly diagnosed patients is 4.83 years.
Brady T, et al. ADX-2191: A new approach for rare proliferative ocular diseases. Presented at: World Orphan Drug Congress USA 2020