Restore Vision has entered into a development and manufacturing partnership with Forge Biologics to support the advancement of RV-001, its investigational adeno-associated virus (AAV) gene therapy for patients with retinitis pigmentosa.

RV-001 is Restore Vision’s lead investigational gene therapy candidate. It uses an AAV vector carrying a proprietary gene that encodes Chimeric Rhodopsin, a protein-based light sensor. The therapy is designed to restore vision in patients who have lost photoreceptor cells due to retinitis pigmentosa.

RV-001 remains an investigational therapy and has not been approved by any regulatory authority. Its safety and effectiveness are still under clinical evaluation.

Under the agreement, Forge Biologics will provide AAV process development, current Good Manufacturing Practices (cGMP) manufacturing, analytical development, stability testing and regulatory support. These activities will be carried out at Forge’s manufacturing facility in Columbus, Ohio, while the finished drug product will be shipped to Japan for use in clinical trials.

The partnership supports the ongoing development of RV-001, which is currently being evaluated in a Phase 1/2 clinical trial in Japan. 

The treatment is delivered through a minimally invasive intravitreal injection, allowing the therapeutic gene to reach the remaining retinal interneurons and potentially restore visual function. The ongoing study in Japan is the first clinical trial to evaluate an optogenetic gene therapy based on Chimeric Rhodopsin.

The collaboration also strengthens Forge Biologics’ experience in supporting clinical-stage gene therapy programmes across the Asia-Pacific region.

 

Source: businesswire.com

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