- Restore Vision and Forge Biologics have entered a development and manufacturing partnership to support RV-001, an investigational AAV gene therapy for retinitis pigmentosa.
- Forge Biologics will provide process development, cGMP manufacturing, analytical development, stability testing, and regulatory consultation, with material supporting a Phase 1/2 clinical trial in Japan.
Restore Vision has partnered with Forge Biologics to support the development and manufacturing of RV-001, its investigational GPCR-based optogenetic adeno-associated virus (AAV) gene therapy for patients with retinitis pigmentosa. Under the agreement, Forge will provide AAV process development, current Good Manufacturing Practices (cGMP) manufacturing, analytical development, stability testing, and regulatory consultation. The work will be carried out at Forge’s 200,000-square-foot facility in Columbus, Ohio, with the drug product transported to Japan for clinical trial supply.
The material manufactured by Forge is being used to evaluate RV-001 in a Phase 1/2 clinical trial in Japan. According to the companies, the collaboration expands Forge’s experience supporting clinical-stage gene therapy programs in the Asia-Pacific region. The partnership also highlights the role of CDMO expertise and contract manufacturing services in advancing gene therapy programs through clinical development.
“Forge is proud to support gene therapy developers around the world with integrated development, manufacturing, and regulatory expertise. Our partnership with Restore Vision reflects our commitment to helping developers navigate the complexities of gene therapy manufacturing, with the shared goal of enabling treatment options for patients.”
John Maslowski, Chief Executive Officer of Forge Biologics
Restore Vision said the collaboration supports the advancement of RV-001 through Phase 1/2 clinical evaluation in Japan. Yusaku Katada, M.D., Ph.D., Chief Executive Officer of Restore Vision, said the company values Forge Biologics’ expertise in AAV development, manufacturing, and regulatory support as it continues the clinical development of the investigational therapy.
