The first global AAV bispecific—Star Eye Biotechnology XMVA09 injection has successfully initiated Phase II clinical trial!

Recently, Star Eye Biotechnology Co., Ltd. successfully held the Phase II initiation meeting for XMVA09 injection, an AAV bispecific drug independently developed by the company to treat wet age-related macular degeneration (wAMD). This marks that XMVA09 injection has become the first AAV bispecific globally to enter Phase II clinical trials, and also the first ophthalmic AAV drug in China that is based on a non-natural capsid to enter Phase II. This initiative opens a new chapter for ophthalmic gene therapy both in China and abroad.

wAMD is the leading cause of irreversible vision impairment in people over 50 years old, affecting approximately 200 million people’s quality of life. Under current standard treatment protocols, patients must receive intravitreal injections of anti-VEGF drugs every 1–2 months. Treatment interruptions or insufficient dosing will lead to a decline in long-term treatment outcomes, resulting in irreversible vision damage. Gene therapy, however, is expected to achieve “one-time administration with lifelong effectiveness.”

As the only gene therapy product in the world that simultaneously features bispecific targeting sites and intravitreal administration, XMVA09 injection uses an AAV gene vector carrying the genes for VEGF-A and Ang-2 bispecific antibodies. Delivered via intravitreal injection, it directly acts on RPE cells to express therapeutic proteins, with the goal of providing long-lasting treatment for wAMD.

XMVA09 injection received approval from the NMPA to enter the clinical stage in March 2024. In early April of this year, the company successfully completed enrollment and dosing for all subjects in Phase I clinical trials. Preliminary results indicate good safety and tolerability. The efficacy data demonstrate significant market advantages. The Phase II initiation meeting for XMVA09 injection to treat wAMD, held in Tianjin, brought together top expert teams in the wAMD treatment field, the core management of Star Eye Biotechnology, and representatives from participating clinical research partners. Together, they discussed the Phase II clinical research protocol and implementation plan for XMVA09 injection.

At the beginning of the meeting, Professor Yan Hua from Tianjin Medical University General Hospital delivered remarks in the opening ceremony, fully affirming the efficient completion of the Phase I trial, emphasizing that it was the result of coordinated efforts among multiple parties, and encouraging the team to advance Phase II with the same level of execution. In his remarks, Dr. Cai Yuan, CEO of Star Eye Biotechnology, first extended sincere thanks to the Phase I clinical trial center teams, appreciating their hard work; meanwhile, he also expressed early appreciation to the teams that would soon join Phase II clinical research, looking forward to close collaboration with all parties. This meeting focused on the scientific substantiation of the Phase II clinical protocol, laying a solid foundation for advancing the project and jointly opening a new clinical stage.

Then, Director Zhou Wei from Tianjin Medical University General Hospital shared data from the Phase I and IIT clinical trials, systematically analyzing the drug’s efficacy and safety. He also shared efficacy data and imaging findings from representative cases, showing that patients’ visual acuity and anatomic indicators improved significantly. Combined with the long-term IIT data, a preliminary assessment indicates that XMVA09 injection has overall efficacy and long-term safety. Liu Mingyue, Medical Manager at Kunling Pharma, reported the results of the Phase I clinical research. By comparing data from similar products domestically and internationally, she noted that the mid- and high-dose groups of XMVA09 showed a clear trend toward efficacy improvement, and she also introduced the Phase II clinical trial protocol, with an in-depth interpretation of key endpoints including inclusion/exclusion criteria and assessment at endpoints. The meeting was hosted by Deng Ming, Project Management Director of Keying Pharma.

During the expert discussion session, experts from multiple clinical centers—including Professor Yan Hua’s team from Tianjin Medical University General Hospital, Professor Gu Yonghao’s team from The First Affiliated Hospital of USTC, Professor Zhong Jie’s team from Sichuan Provincial People’s Hospital, Professor Han Mei’s team from Tianjin Eye Hospital, Professor Shen Lijun’s team from Zhejiang Provincial People’s Hospital, Professor She Haicheng’s team from Beijing Tongren Hospital Affiliated to Capital Medical University, Professor Yuan Lili’s team from Shanxi Eye Hospital, and Professor Lei Chunling’s team from Xi’an People’s Hospital—conducted in-depth exchanges around core topics such as “refining efficacy evaluation endpoints” and “further detailing patient enrollment criteria.” Based on their extensive clinical research experience, the experts from each center proposed multiple constructive recommendations for the Phase II trial protocol.

Finally, in her closing remarks, Professor Yan Hua stated that through practical and efficient discussion, the meeting reached consensus on key issues, laying a solid foundation for the smooth conduct of Phase II clinical trials. Next, the team will, while ensuring research quality, accelerate the efficient implementation of the Phase II work.

Dr. Miao Bolong, CMO of Star Eye Biotechnology, said: “XMVA09 injection, as the first bispecific innovative therapy administered via intravitreal injection, is expected to significantly reduce injection frequency for patients with wAMD and become a future first-line maintenance therapy for wAMD. We believe that, with the rich clinical experience of expert teams and strong advancement through close cooperation among all parties, the clinical trials of XMVA09 injection will move forward steadily and soon bring hope to many patients.”

Dr. Cai Yuan, CEO of Star Eye Biotechnology, said: “The launch of this key Phase II clinical trial marks an important milestone for Star Eye in the near term, and it is a crucial step in validating our technological strengths. XMVA09 injection, with excellent clinical benefits, is moving calmly and smoothly into the next stage. This progress is inseparable from the support of all our partners, the trust of all our shareholders, as well as the dedication of our team and their concerted collaboration. Star Eye Biotechnology will continue to focus on R&D, using the most cutting-edge gene therapy technologies to develop leading innovative products and benefit the broadest possible patient population.”

About Star Eye Biotechnology

Star Eye Biotechnology is a high-tech enterprise developing ophthalmic gene therapy products based on advanced gene editing technologies. The company focuses on the R&D of gene therapy drugs for ophthalmic diseases. Its core team is a doctoral entrepreneurship team led by a “Distinguished Young Scientist” and has two major core technology platforms on the R&D side: the AAV–antibody gene drug platform (bispecific optimization platform, capsid screening platform) and the gene editing platform.

The company is committed to developing ophthalmic gene therapy drugs that are suitable for independent use by people in China. It actively promotes gene therapy into ophthalmology broad indications. Using ophthalmology as a breakthrough point—especially common ophthalmic diseases represented by age-related macular degeneration—the company aims to help people in China see for longer and see better.