Skyline Therapeutics has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug SKG0106, an intraocular injection solution for the treatment of neovascular age-related macular degeneration (nAMD).
Innovative Gene Therapy Mechanism
SKG0106 is a recombinant adeno-associated virus (rAAV) gene therapy drug, utilizing a novel AAV capsid that encodes a unique gene sequence for an anti-VEGF protein. Following a single intravitreal injection, the drug efficiently transduces retinal cells in the eye, leading to the continuous expression of functional proteins that combat neovascularization. This mechanism inhibits neovascularization, blocks vascular leakage, reduces retinal edema, and slows the progression of nAMD.
Global Clinical Approvals
The approval by NMPA follows similar clearances received by Skyline Therapeutics in the United States, marking a significant milestone in the global development of SKG0106. These approvals position the drug to potentially transform the treatment landscape for nAMD, offering a novel therapeutic option for patients suffering from this debilitating condition.-Fineline Info & Tech
