Skyline Therapeutics
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Skyline Therapeutics’s SKG0106 Approved by NMPA for Clinical Trials
October 2023 , Skyline Therapeutics announced that the clinical trial application (IND) of SKG0106 is approved by the China National Medical Products Administration (NMPA) for the treatment of neovascular age-related macular degeneration (nAMD). SKG0106 was approved by the U.S. Food and Drug Administration (FDA) earlier this year to conduct a global Phase I/IIa clinical trial for the treatment of neovascular age-related macular degeneration (nAMD). The global clinical trial has been launched. SKG0106 is a distinctively designed recombinant adeno-associated virus (rAAV)-mediated gene therapy for ocular disease. It encompasses a proprietary novel…
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Skyline Therapeutics Receives FDA Clearance of IND for SKG0106 for Age-related macular degeneration (AMD)
July 2023, Skyline Therapeutics announced that the U.S. FDA has cleared its IND application for Phase I/IIa clinical trial of SKG0106, a one-time intravitreally delivered AAV gene therapy for the treatment of neovascular age-related macular degeneration (nAMD). Global Phase I clinical trial will be initiated soon. Age-related macular degeneration (AMD) is a progressive disease that can severely impair central vision and is a leading cause of irreversible blindness in the elderly. Neovascular age-related macular degeneration (nAMD), characterized by the formation of choroidal neovascularization (CNV), bleeding, and exudation, accounts for up…
