Xingmou Biotech Receives Third IND Approval for AAV Gene Therapy XMVA09 in Diabetic Macular Edema

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On August 19, 2024, StarryGene announced that the second Investigational New Drug (IND) application for its self-developed gene therapy Class I innovative drug "XMVA09 Injection" has been approved by the National Medical Products Administration (NMPA). In March this year, the IND application for XMVA09 Injection for the treatment of wet age-related macular degeneration (wAMD) received clinical tacit approval from the Center for Drug Evaluation (CDE). The newly approved indication is diabetic macular edema (DME).

Diabetic Macular Edema: A Common Ocular Complication in Diabetic PatientsDiabetic macular edema is a common ocular complication among diabetic patients, primarily affecting the macular region at the center of the retina. The macula, a crucial area responsible for visual acuity, causes vision loss or even blindness when edema occurs. The core goal of treating this eye condition is to maintain and improve vision, with significant clinical demand. Currently, anti-vascular endothelial growth factor (anti-VEGF) represents the safest and most effective therapeutic target in clinical practice.

XMVA09 Injection is a gene therapy drug independently developed by StarryGene. Compared with the 1-3 month injection cycle of traditional antibody therapy drugs, gene therapy drugs can produce sustained therapeutic effects and are expected to achieve...One injection for life-long effectiveness, greatly benefiting patients. XMVA09 injection uses a novel AAV capsid, which can infect retinal pigment epithelium (RPE) cells adjacent to choroidal lesions through intravitreal injection, providing a more convenient route for subsequent clinical applications. In addition, XMVA09 injection adopts a dual-target design, simultaneously targeting vascular endothelial growth factor (VEGF) and angiopoietin-2 (ANG-2), enhancing the therapeutic effect of the drug and increasing coverage for patients who are insensitive to VEGF.

Dr. Cai Yuan, Founder and CEO of StarryGeneStarryGene stated, "The approval of the IND for the DME indication is strong evidence of the development potential of XMVA09 injection. We are committed to pushing the boundaries of ophthalmic disease treatment through innovative technology. This achievement marks a solid step forward in realizing our vision. We look forward to XMVA09 injection bringing more light and hope to patients in clinical practice!"

Dr. Bolong Miao, Chief Medical Officer of StarryGeneStarryGene stated: "XMVA09 injection has demonstrated good safety and efficacy in the clinical research for wAMD indications. The approval of the DME indication further validates the broad applicability and therapeutic potential of our drug. We believe that the approval of this new DME indication will further expand our ability to serve patients, providing more treatment options for those with diabetic macular edema."

StarryGene is a high-tech enterprise that develops cutting-edge gene editing technologies and researches 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 Scientist," with two key technology platforms on the R&D side: the AAV-Antibody Gene Drug Platform (including a bispecific antibody optimization platform and a capsid screening platform) and the gene editing platform. The company is committed to developing gene therapy drugs for ophthalmic use that are independently accessible to people in China, actively advancing gene therapy into major ophthalmic indications. Using ophthalmology as a breakthrough, especially common eye diseases such as age-related macular degeneration as the main entry point, StarryGene aims to help people in China see longer and better.

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