In This Article:
Release Date: November 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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Clearside Biomedical Inc (NASDAQ:CLSD) reported positive results from the Odyssey phase two B clinical trial for wet AMD, demonstrating potential efficacy and safety of CLS AX.
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The company is the only TKI Wet AMD program with repeat dosing data, providing a competitive advantage as they advance CLS AX into phase three.
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Clearside's SCS microinjector has been successfully used in over 10,000 injections, showcasing its safety and reliability.
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The company has solidified its formulation expertise and has commercial scale microinjector manufacturing capability with ISO certification.
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Clearside's collaboration with Arctic Vision and Santan Pharmaceuticals highlights strategic validation of their super choroidal delivery platform.
Negative Points
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Clearside Biomedical Inc (NASDAQ:CLSD) has cash and cash equivalents totaling $23.6 million, which is only sufficient to fund operations into the third quarter of 2025.
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The company is still in the planning stages for the phase three trial of CLS AX, with details such as cost and design yet to be finalized.
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There is uncertainty regarding the FDA's acceptance of flexible dosing for CLS AX, which is crucial for its adoption in the wet AMD market.
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The geographic atrophy program is still in early stages, with no clear timeline for IND submission.
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Clearside faces competition in the TKI space, and the success of their flexible dosing strategy remains to be seen.
Q & A Highlights
Q: Can you provide feedback from the AAO meeting regarding the study design that incorporated retreatment rather than supplemental rescue with aflibercept, and the 3 to 6 months flexibility you're looking for on your label? A: The feedback from the AAO meeting was very positive. Attendees appreciated the flexibility offered by our approach, which is a key differentiator. The retreatment design was well-received, and the flexibility aligns with physician needs for varying treatment schedules. (George Lake, CEO; Dr. Victor Chang, Chief Medical Officer)
Q: Are there any concerns about the FDA's view on redosing CLSAX within six months? A: We have no concerns from the FDA's perspective. Our Phase 2 study already demonstrated the safety of redosing within six months, and we have data supporting multiple redosing. (Dr. Victor Chang, Chief Medical Officer)
Q: Can you provide more details on the Phase 3 trial design for CLSAX and the geographic atrophy program? A: The Phase 3 trial will likely follow a non-inferiority design with flexible dosing, similar to aflibercept's high-dose design. For geographic atrophy, we're exploring small molecules targeting choroidal perfusion and inflammation, with plans to advance candidates toward an IND application. (Dr. Victor Chang, Chief Medical Officer)