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Aldeyra begins phase 3 proliferative vitreoretinopathy prevention trial
Aldeyra has enrolled the first patient in a phase 3 clinical trial of ADX-2191 for the prevention of recurrent retinal detachment due to proliferative vitreoretinopathy, according to a press release.
The two-part, multicenter, randomized, controlled, adaptive, phase 3 GUARD trial is evaluating the efficacy of ADX-2191 (intravitreal methotrexate) vs. standard of care.
“PVR is a very serious retinal disease for which there is no effective treatment,” Dean Eliott, MD, Stelios Evangelos Gragoudas Professor of Ophthalmology at Harvard Medical School and director of the retina service at Massachusetts Eye and Ear Infirmary, told Healio.com/OSN. “We now have a drug that exhibits some potential based on encouraging laboratory data and early testing in patients. [Methotrexate] is an antiproliferative and anti-inflammatory agent. Cellular proliferation and inflammation play a role in the pathogenesis of PVR, so it is thought that repeated intravitreal methotrexate injections might decrease the development of scar tissue that characterizes PVR.”
The trial will compare recurrent retinal detachment rates over a 24-week postoperative period and evaluate the drug’s safety and efficacy.
“If this trial is successful and the drug ultimately gets approved, we would be able to decrease the incidence of recurrent retinal detachment, thereby preventing the severe vision loss that occurs with each ensuing detachment,” Eliott said.
The FDA previously granted ADX-2191 fast track designation and orphan drug designation. – by Rebecca L. Forand
Disclosures: Eliott reports he is a co-founder of Helio Vision (with Tomasz Stryjewski and Joe von Rickenbach) which was acquired by Aldeyra Therapeutics, and he is an Aldeyra stockholder.