Restore Vision Begins Phase I/II Trial of RV-001 for Retinitis Pigmentosa

Restore Vision Inc., a pioneering biotechnology company focused on retinal disorders, is making significant strides in the field of gene therapy. The company recently announced the administration of RV-001, a groundbreaking optogenetic gene therapy, to the first participant in a Phase I/II clinical trial conducted at Keio University Hospital in Tokyo. This trial represents a world-first in testing a "Chimeric Rhodopsin" gene therapy on humans.

RV-001 employs adeno-associated virus (AAV) vectors to transport a specially engineered gene that encodes "Chimeric Rhodopsin." This gene utilizes a light-driven G-protein activation mechanism designed to restore light sensitivity in retinal interneurons. The therapy's objective is to improve light sensitivity in patients with retinitis pigmentosa (RP), a condition that affects over two million people worldwide, leading to progressive vision deterioration and eventual blindness. The administration of RV-001 involves an intravitreal injection aimed at enhancing the light sensitivity of retinal interneurons, providing hope to those suffering from this debilitating condition.

Dr. Yusaku Katada, the CEO of Restore Vision Inc. and an experienced ophthalmologist, emphasized the therapy's potential to transform light sensitivity for a wide range of RP patients. The ongoing Phase I/II trial aims to evaluate the safety, light-activation, and light-sensitivity effects of RV-001 on patients who have received the therapy.

The clinical trial focuses on individuals with advanced RP, regardless of their genetic background, who experience severe vision impairment or no vision at all. In addition to assessing safety, the trial will explore potential improvements in light sensitivity and visual function, marking a significant step forward in the treatment of inherited retinal disorders.

Restore Vision Inc. originated as a spin-out from Keio University and represents a fusion of academic research and entrepreneurial innovation. The company's technology was developed in collaboration with Keio University School of Medicine and Nagoya Institute of Technology. RV-001 is designed to overcome the limitations of conventional treatments by merging high light sensitivity with a distinctive G-protein activation mechanism. This innovative approach holds promise not only for RP but potentially for other retinal diseases, opening the door for broader applications in the field of vision restoration.

The development of RV-001 has been supported by the Japan Agency for Medical Research and Development (AMED) and various academic grants, with significant contributions from Keio University and Nagoya Institute of Technology. This collaborative effort underscores the importance of integrating academic knowledge with entrepreneurial vision to drive the advancement of transformative therapies for inherited retinal disorders.

Restore Vision is dedicated to revolutionizing treatments for retinal diseases by leveraging cutting-edge gene therapy techniques. The company remains committed to addressing unmet medical needs and enhancing patient outcomes on a global scale. With the RV-001 trial now underway, Restore Vision is at the forefront of developing innovative solutions that have the potential to significantly improve the quality of life for individuals affected by retinal conditions.