LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, today 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,” said Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “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, multi-center, 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 U.S. Food and Drug Administration (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.
About Proliferative Vitreoretinopathy
Proliferative vitreoretinopathy (PVR) is a rare inflammatory fibroproliferative disorder that leads to severe retinal scarring and blindness, and is the leading cause of failure of retinal reattachment surgery. Approximately 40% to 50% of PVR cases result in severe uncorrectable vision loss (visual acuity of 20/320 or worse), and 76% of PVR patients suffer from at least moderate uncorrectable vision loss. PVR complicates up to 10% of surgeries for retinal detachment and 50% or more of surgeries for open globe injury. There is currently no approved therapy for the treatment of PVR.
About Aldeyra Therapeutics
Aldeyra Therapeutics is a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases. Aldeyra's lead investigational drug product candidates are potential first-in-class treatments in development for dry eye disease, allergic conjunctivitis, proliferative vitreoretinopathy, and Sjögren-Larsson Syndrome. The company is also developing other product candidates for retinal and systemic inflammatory diseases.
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