Xingmou Biotech Completes First Patient Dosing in Phase I Clinical Trial of XMVA09, a Novel Gene Therapy for Wet Age-Related Macular Degeneration (wAMD)

On June 21, StarryGene announced that its gene therapy drug XMVA09 injection had successfully completed the first patient dosing in the Phase I clinical trial.

Wet age-related macular degeneration (wAMD) is the leading cause of irreversible vision loss in people over 50, affecting approximately 200 million people worldwide.。

XMVA09 Injection is the world's only gene therapy drug that combines dual antibody targets and intravitreal injection. The productUsing AAV gene vector carrying VEGF-A and Ang-2 bispecific antibody genes, directly targeting retinal pigment epithelium (RPE) cells through intravitreal injection, expressing therapeutic proteins, thereby achieving the goal of long-term treatment for wAMD.

In the IIT study previously conducted at the First Affiliated Hospital of the University of Science and Technology of China, all six wAMD subjects enrolled showed excellent treatment outcomes without receiving anti-VEGF prospective loading therapy. Among them, the first patient, who had the longest observation period, underwent 15 months of clinical follow-up after medication, with a significant increase in BCVA (Best Corrected Visual Acuity).The interim results of the IIT indicate that the XMVA09 injection is safe, well-tolerated, and has preliminarily met the expected research goals in terms of efficacy.。 

StarryGene Chief Medical Officer Miao Bolong expressed: "We sincerely thank our clinical PI team and partners for their efforts! StarryGene will provide the utmost support to ensure the high-quality and timely completion of the trial. Meanwhile, patient welfare and drug safety remain the top priorities for the entire PI team and StarryGene, and we will spare no effort. Once again, we thank all the medical experts and team members for their professionalism and perseverance."

StarryGene is a high-tech enterprise that develops cutting-edge gene editing technologies and gene therapy products for ophthalmic diseases, focusing on the development of ophthalmic gene therapy drugs. The core team of StarryGene is a doctoral entrepreneurial team led by a "Distinguished Young Scholar."At the R&D end, the team has two core technology platforms: the AAV-antibody gene drug platform (dual-antibody optimization platform, capsid screening platform) and the gene editing platform.The company is committed to the research and development of ophthalmic gene therapy drugs that are independently accessible to the Chinese people. It actively promotes the application of gene therapy in major ophthalmic indications, with ophthalmology as the breakthrough point—especially common ophthalmic diseases such as age-related macular degeneration—as the main focus, enabling the Chinese people to see longer and better.