Clearside Biomedical, Inc. Q3 FY2024 earnings call

George Lasezkay mentioned the positive results from the ODYSSEY Phase 2b clinical trial in wet AMD, noting CLS-AX's potential efficacy, safety, and versatility, with repeat dosing data giving a competitive edge. Victor Chong discussed the ODYSSEY trial's safety, efficacy, and duration benefits, and plans for Phase 3, as well as opportunities in geographic atrophy. Clearside's suprachoroidal platform is highlighted, with the SCS Microinjector having over 10,000 injections, XIPERE's approval, and partnerships with various companies advancing suprachoroidal delivery programs.

George mentioned an end-of-Phase 2 meeting with the FDA is planned for early 2025 to finalize Phase 3 plans. Victor stated the target to start the Phase 3 trial in the second half of 2025. They also discussed advancing preclinical suprachoroidal programs.

Q: Annabel Samimy asked about feedback on the AAO presentation, retreatment vs. supplemental rescue, and non-inferiority margins for Phase 3.

A: George and Victor responded on positive AAO feedback, differentiation in flexibility, and that non-inferiority margin details will be worked out in the end-of-Phase 2 meeting.

Q: Andreas Argyrides inquired about Phase 3 trial design, geographic atrophy program expansion, and Phase 3 trial start timing.

A: Victor responded on Phase 3 design similarity to others, geographic atrophy focus on choroidal perfusion and inflammatory cells, and target to start Phase 3 in second half of 2025.

Q: Debanjana Chatterjee asked about additional ODYSSEY data analysis and when it would be shared.

A: Victor stated more data will be shared in upcoming medical conferences like APVRS, Floretina, and others.

Q: Unidentified Analyst asked about FDA apprehension on redosing and cost of Phase 3, and elaboration on geographic atrophy mechanism.

A: Victor responded on no FDA concern due to Phase 2 data, cost details to come with Phase 3 design, and elaborated on geographic atrophy being a choroidal disease related to choroidal endothelial cells and perfusion.