Clearside Biomedical, Inc. (CLSD) Suprachoroidal Space Drug Delivery (Transcript)

Core Insights - Clearside Biomedical is focused on the potential of suprachoroidal drug delivery, positioning itself as a leader in this innovative space with a proprietary SCS Microinjector that has been validated through numerous clinical injections [7][10][37] - The company has developed the first FDA-approved product for suprachoroidal administration, XIPERE, which is currently being commercialized in the U.S. and is seeking approval in Canada and Australia [12][37] - The pipeline includes CLS-AX, a tyrosine kinase inhibitor for wet AMD, which is completing Phase IIb trials, with data expected in late Q3 2024 [8][11][56] Company Overview - Clearside Biomedical has established multiple strategic collaborations to enhance its capabilities in the suprachoroidal space, including partnerships with Aura, REGENXBIO, AbbVie, and BioCryst [13][14] - The company has a comprehensive intellectual property portfolio surrounding its microinjector platform, which supports various drug categories for retinal diseases [7][10] Product Development - The SCS Microinjector has been used in over 10,000 injections without reported cases of endophthalmitis, indicating a favorable safety profile compared to traditional intravitreal injections [40] - XIPERE has shown promising real-world efficacy, with approximately 86.5% of patients not requiring rescue therapy within six months, comparable to clinical trial results [30][37] Market Potential - The market for geographic atrophy is considered larger than that for wet AMD, with ongoing research into improving treatment efficacy and duration [58] - The company aims to leverage its expertise in suprachoroidal delivery to develop therapies targeting geographic atrophy, which is increasingly recognized as a choroidal disease [62][66] Future Outlook - Clearside Biomedical plans to initiate a Phase III study for CLS-AX, which is expected to provide data that could facilitate its approval and integration into clinical practice [55][56] - The company is exploring the potential of gene therapy applications through its suprachoroidal delivery system, which may offer advantages over traditional methods [66][68]