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On December 6, 2023, the IND application for XMVA09 Injection, an innovative gene therapy drug independently developed by StarryGene, was accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration. The product is indicated for wet age-related macular degeneration (wAMD).
Screenshot of the official website of the Drug Review Center
XMVA09 Injection is the first gene therapy drug developed by StarryGene, which was already available in the First Affiliated Hospital of University of Science and Technology of China in 2023.(Anhui Provincial Hospital)Conduct investigator-initiated clinical research (IIT), in which no drug-related adverse events or serious adverse events occurred in patients.The Longest Observation PeriodThe first patient has been dosed.Nearly one year of clinical follow-up observation, the patient had a significant increase in BCVA, complete absorption of subretinal fluid, and no further rescue treatment with antibody drugs during this period;Optimal Clinical BenefitThe two patientsThe increase in BCVA reached an astonishing 12 letters., with extremely significant clinical benefits.
ETDRS Chart for BCVA Testing
The safety of XMVA09 stems from its low immunogenicity bispecific antibody design and the new capsid enabling intravitreal injection. Particularly, intravitreal injection in the eye involves a series of issues including safety, operability, patient compliance, and commercialization thresholds. Considering the significant operational difficulty of subretinal injection and the associated high incidence of safety events (for instance, Luxturna reported adverse events at around 60%), StarryGene has focused on capsid development, creating a capsid for intravitreal injection that infects retinal pigment epithelial cells. This ensures drug delivery to neovascular lesions while maintaining the safety of the procedure.StarryGene is a high-tech enterprise that develops cutting-edge gene editing technologies and gene therapy products for ophthalmic diseases. Focused on the development of ophthalmic gene therapy drugs, the company is committed to making gene therapies accessible and available in China, actively advancing gene therapy into major ophthalmic indications. With ophthalmology as its breakthrough area, especially common eye conditions such as age-related macular degeneration, StarryGene aims to help people in China see longer and better.
Article SourceSource:StarryGene
