Clearside Biomedical Announces Successful End-of-Phase 2 Meeting with the FDA and Alignment on Phase 3 Plans for Suprachoroidal CLS-AX in Wet AMD

Core Insights - Clearside Biomedical has received positive feedback from the FDA regarding its CLS-AX program for treating wet AMD, indicating a promising path forward for the Phase 3 trials [2][4] - CLS-AX aims to differentiate itself in the $12+ billion wet AMD market through flexible dosing and extended duration compared to existing therapies [2][4] Company Overview - Clearside Biomedical is focused on revolutionizing therapy delivery to the back of the eye using its proprietary suprachoroidal space (SCS) injection platform [7] - The company is developing CLS-AX, an injectable suspension of axitinib, which is a tyrosine kinase inhibitor that targets VEGF receptors to potentially improve treatment outcomes for retinal diseases [4][7] CLS-AX Phase 3 Program - The proposed Phase 3 program includes two pivotal non-inferiority trials with a primary endpoint of average change in best corrected visual acuity (BCVA) at Week 52 [5] - Each trial will involve approximately 225 participants per arm, comparing CLS-AX (1 mg) to aflibercept (2 mg), focusing on treatment-naïve participants to expedite recruitment [5] - The trials are designed to support a flexible maintenance dosing label for CLS-AX, allowing for administration every 3 to 6 months based on physician assessments [2][5] Clinical Development and Safety - CLS-AX has demonstrated a positive safety profile and re-dosing capability in previous clinical trials, indicating its potential as a compelling alternative in the wet AMD market [2][4] - The company plans to conduct a one-year safety follow-up period to meet registration requirements, ensuring comprehensive safety data is available [5] SCS Injection Platform - Clearside's SCS injection platform allows for targeted delivery of therapies to the back of the eye, potentially improving efficacy and reducing toxic effects on non-diseased cells [6][7] - The SCS Microinjector is designed for precise administration of various drug candidates, enhancing the treatment of sight-threatening diseases [6][7]