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

Clearside Biomedical, Inc. Conference Call Summary Company Overview - Company: Clearside Biomedical, Inc. (NASDAQ:CLSD) - Focus: Suprachoroidal drug delivery system for retinal diseases - Key Product: XIPERE, the first FDA-approved product for suprachoroidal administration Key Industry Insights - Suprachoroidal Delivery: - Recognized as a versatile and innovative method for drug administration in retinal diseases, offering advantages over traditional intravitreal and subretinal injections [6][12] - The SCS Microinjector has been validated through thousands of clinical injections and is supported by a comprehensive intellectual property portfolio [6][7] Core Points Discussed 1. Pipeline and Product Development: - CLS-AX, a tyrosine kinase inhibitor for wet AMD, is completing Phase IIb trials, with data expected in late Q3 2024 [7][30] - XIPERE is being commercialized in the U.S. by Bausch & Lomb and is seeking approval in Canada and Australia [9] - Collaborations with companies like Aura, REGENXBIO, AbbVie, and BioCryst to expand the application of the SCS Microinjector [10] 2. Real-World Efficacy: - The PEACHTREE study showed that 86.5% of patients did not require rescue therapy within six months after receiving XIPERE [16] - Real-world data from the IRIS Registry supports the efficacy of XIPERE, with a similar low rate of rescue therapy needed [25] 3. Safety Profile: - Suprachoroidal injections are believed to have a lower risk of endophthalmitis compared to intravitreal injections, with no reported cases after over 10,000 injections [27] - The procedure is quick, taking about 10 seconds longer than intravitreal injections, and is associated with fewer complications [28] 4. Market Positioning: - CLS-AX is positioned to compete with leading products like VABYSMO and EYLEA, with potential for less frequent dosing (2-3 times a year) compared to competitors [31] - The company aims to leverage its experience with the SCS Microinjector to expedite the approval process for CLS-AX [30] 5. Future Directions: - Plans to expand into geographic atrophy treatment, which is more common than wet AMD, with a focus on targeting the choroidal disease aspect [37][39] - Exploration of gene therapy applications using the suprachoroidal delivery method, which may offer advantages in terms of safety and efficacy [41][42] Additional Considerations - Patient Selection and Procedure: - Emphasis on careful patient selection, particularly for those with high myopia or glaucoma history [17] - The procedure requires specific techniques to minimize discomfort and ensure successful delivery [21] - Regulatory and Reimbursement Landscape: - The CPT code for SCS injections aids in physician reimbursement, reflecting a favorable economic model for the procedure [28] - Clinical Insights: - Discussions highlighted the importance of real-world treatment criteria versus clinical trial criteria, advocating for flexibility in treatment approaches [50][56] Conclusion Clearside Biomedical is positioned as a leader in the suprachoroidal drug delivery space, with a robust pipeline and strategic collaborations. The company is focused on expanding its product offerings while ensuring safety and efficacy in real-world applications, potentially transforming treatment paradigms for retinal diseases.