The world’s first AAV-delivered bispecific antibody gene therapy drug initiates Phase II clinical trial

Recently, StarEye Biotech Co., Ltd. successfully held the Phase II clinical trial initiation meeting for XMVA09 Injection, its independently developed therapy for wet age-related macular degeneration (wAMD). This marks XMVA09 Injection as the world’s first AAV-delivered bispecific antibody gene therapy to enter Phase II clinical trials, as well as China’s first ophthalmic AAV drug based on a non-natural capsid to enter Phase II clinical development, opening a new chapter in ophthalmic gene therapy both in China and globally. As a strategic partner of StarEye Biotech, PackGene extends its warm congratulations on this significant progress. We look forward to continuing our collaboration with StarEye Biotech to accelerate the commercialization of XMVA09 Injection and benefit more patients.

wAMD is a leading cause of irreversible vision impairment in people over the age of 50, affecting the quality of life of approximately 200 million people worldwide. Under current standard treatment regimens, patients need to receive intraocular injections of anti-VEGF drugs once every 1–2 months. Treatment interruption or undertreatment can lead to reduced long-term treatment efficacy and irreversible vision loss, while gene therapy is expected to achieve the goal of “one-time administration with lifelong efficacy.” As the world’s only gene therapy drug featuring both bispecific antibody targets and intravitreal administration, XMVA09 Injection uses an AAV gene vector carrying the genes encoding a VEGF-A/Ang-2 bispecific antibody. Through intravitreal injection, it directly targets RPE cells to express therapeutic proteins, aiming to achieve long-term treatment of wAMD.

XMVA09 Injection was approved by the NMPA to enter clinical development in March 2024. In early April this year, it successfully completed enrollment and treatment of all subjects in its Phase I clinical trial. Preliminary results demonstrated good safety and tolerability, while efficacy data showed significant market advantages. The Phase II initiation meeting for XMVA09 Injection in the treatment of wAMD, held in Tianjin, brought together leading experts in the field of wAMD treatment in China, StarEye Biotech’s core management team, and representatives from clinical research partners to jointly discuss the Phase II clinical study protocol and execution plan for XMVA09 Injection.

Dr. Bolong Miao, CMO of StarEye Biotech, said: “As the first intravitreally injected bispecific antibody innovative therapy, XMVA09 Injection is expected to significantly reduce the injection frequency for wAMD patients and become a first-line maintenance therapy for wAMD in the future. We firmly believe that, driven by the expert team’s extensive clinical experience and the close collaboration of all parties, the clinical trial of XMVA09 Injection will progress steadily and bring benefits to many patients as soon as possible.”

Dr. Yuan Cai, CEO of StarEye Biotech, said: “The initiation of this pivotal Phase II clinical trial represents a recent key milestone for StarEye Biotech and an essential step in validating the company’s technological advantages. XMVA09 Injection has advanced smoothly to the next stage with excellent clinical benefits, which would not have been possible without the support of all our partners, the trust of all shareholders, and the dedication and close collaboration of our team. StarEye Biotech will continue to focus on R&D, leverage cutting-edge gene therapy technologies to develop leading innovative products, and benefit the broadest patient population.”

About StarEye Biotech

StarEye Biotech is a high-tech enterprise focused on the development of gene therapy products for ophthalmic diseases, based on cutting-edge gene editing technologies. The company focuses on ophthalmic gene therapy drug development. Its core team is a doctoral entrepreneurial team led by a recipient of the National Science Fund for Distinguished Young Scholars. On the R&D side, StarEye has two core technology platforms: an AAV-antibody gene drug platform comprising a bispecific antibody optimization platform and a capsid screening platform, and a gene editing platform. The company is committed to developing independently accessible ophthalmic gene therapy drugs for Chinese patients and actively advancing gene therapy into major ophthalmic indications. With ophthalmology as its breakthrough area, especially common eye diseases represented by age-related macular degeneration, StarEye aims to help Chinese people preserve their vision longer and see better.

PackGene is honored to participate in StarEye Biotech’s XMVA09 Injection project by providing a full suite of CMC services from plasmid to AAV, supporting the advancement of XMVA09 Injection into Phase II clinical trials for wet age-related macular degeneration (wAMD). We express our respect and congratulations for StarEye Biotech’s innovation and achievements in the field of gene therapy, and look forward to continued in-depth collaboration between both parties to jointly promote innovation and development in the biopharmaceutical industry and contribute to human health.