Clearside Biomedical Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

Core Insights - Clearside Biomedical, Inc. has successfully completed an End-of-Phase 2 meeting with the FDA, aligning on Phase 3 plans for CLS-AX in the treatment of wet AMD [1][3] - The company’s Asia-Pacific partner, Arctic Vision, has had its New Drug Application for ARCATUS accepted for regulatory review in China [1][3] - Multiple presentations at medical meetings have highlighted the advantages of Clearside's suprachoroidal drug delivery system [1][8] Recent Developments - The FDA meeting confirmed key elements of the Phase 3 program for CLS-AX, including trial design and endpoints, based on positive Phase 2b results [3] - Arctic Vision's NDA for ARCATUS has been accepted in China, with previous approvals in Australia and Singapore [3] - Clearside's partners are advancing their suprachoroidal drug candidates into Phase 3 trials, including REGENXBIO and Aura Biosciences [3] Financial Performance - For Q4 2024, Clearside reported license and other revenue of $0.3 million, down from$6.3 million in Q4 2023 [4][5] - R&D expenses for Q4 2024 were $4.2 million, a decrease from$6.3 million in Q4 2023, attributed to lower clinical trial costs [4][5] - The net loss for Q4 2024 was $7.3 million, compared to a net loss of$4.8 million in Q4 2023 [4][5] Company Overview - Clearside Biomedical is focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space, utilizing its patented SCS Microinjector [9] - The company is developing a pipeline of small molecule candidates, with its lead program, CLS-AX, targeting wet AMD [9] - Clearside has also developed XIPERE, which is commercially available in the U.S. through a partner [9]