The first optogenetic 'Chimeric Rhodopsin' gene therapy tested in humans. RV-001 starting dose was generally well tolerated in this open-label trial. RV-001 a gene-agnostic approach for RP patients. TOKYO, Feb. 13, 2025 /PRNewswire/ -- Restore Vision Inc., a clinical-stage biotechnology company advancing gene therapies for retinal disorders, today announced that the first patient in its Phase I/II clinical trial with RV-001 has been dosed at Keio University Hospital. RV-001 utilizes adeno-associated virus (AAV) vectors to deliver a unique functional gene encoding 'Chimeric Rhodopsin', a light-driven G-protein activation mechanism to re-establish light activation in retinal interneurons. The goal is to expand light sensitivity to retinal interneurons via an intravitreal injection of RV-001. This milestone marks the initiation of the world's first clinical trial of optogenetic gene therapy, which leverages a proprietary 'Chimeric Rhodopsin' for patients with retinitis pigmentosa (RP). 'Over 2 million people worldwide suffer photoreceptor loss in retinitis pigmentosa, resulting in severe vision loss and eventual blindness' said, CEO and Ophthalmologist Yusaku Katada, MD, PhD. 'Our 'chimeric rhodopsin' approach has broad potential to alter light sensitivity across multiple subtypes of RP patients.[1] We are continuing to advance the Phase I/II trial to assess safety, light-activation and light-sensitivity in these patients, post-administration of our lead gene therapy product RV-001.'