UPDATE – Kalaris Therapeutics Now Enrolling Phase 1b/2 Multiple Ascending Dose Study of TH103 in Neovascular Age-Related Macular Degeneration

Core Insights - Kalaris Therapeutics has initiated a Phase 1b/2 multiple ascending dose study for TH103 targeting neovascular age-related macular degeneration (nAMD) patients, with initial data expected in the second half of 2026 [1][6] - The Phase 1b/2 study aims to evaluate multiple dose levels of TH103 in up to 80 nAMD patients, following four initial monthly intravitreal injections [1][2] - The ongoing Phase 1a single ascending dose study is on track for data reporting in Q4 2025, which will include safety, preliminary efficacy, and pharmacokinetics [2][6] Company Overview - Kalaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for prevalent retinal diseases, particularly those with significant unmet medical needs [8] - The company was founded by Dr. Napoleone Ferrara, known for his pioneering research in anti-VEGF therapy, which has transformed treatment for cancer and retinal diseases [3][8] - TH103 represents a novel dual-action investigational therapy designed to provide increased and longer-lasting anti-VEGF activity for conditions like nAMD, diabetic macular edema (DME), and retinal vein occlusion (RVO) [6][8] Industry Context - Neovascular age-related macular degeneration (nAMD) is a leading cause of vision loss in individuals over 50, affecting millions globally, and highlights the need for continued innovation in therapeutic options [5][6] - Current anti-VEGF therapies have improved treatment outcomes, but many patients still experience progressive vision loss, indicating a gap in effective treatment solutions [5]