Release Date: March 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Clearside Biomedical Inc (CLSD, Financial) has successfully completed over 15,000 suprachoroidal injections, showcasing the reliability and safety of their SCS Microinjector.
- Positive results from the ODYSSEY Phase 2b wet AMD clinical trial led to a successful end of Phase 2 meeting with the FDA, aligning on a pivotal Phase 3 program for CLS-AX.
- The company has achieved regulatory milestones in Asia-Pacific regions, with approvals in Australia and Singapore and a new drug application under review in China.
- Clearside Biomedical Inc (CLSD) has multiple partnerships, including with Arctic Vision and REGENXBIO, which are advancing suprachoroidal treatments in various indications.
- The company is exploring additional pipeline opportunities beyond wet AMD, including potential treatments for geographic atrophy using suprachoroidal delivery.
Negative Points
- Clearside Biomedical Inc (CLSD) has cash and cash equivalents totaling approximately $20 million, which may only fund operations into the fourth quarter of 2025, indicating a need for additional funding.
- The company is actively pursuing options to fund the CLS-AX Phase 3 program, including potential partnerships, which suggests financial constraints.
- Enrollment for the Phase 3 trial is expected to take around 12 months, which could delay the timeline for potential market entry.
- The company faces competition in the wet AMD market, which represents over $12 billion in annual sales, from established treatments with proven efficacy.
- There is a risk of variability in clinical trial results due to patient performance on vision tests, which the company is attempting to mitigate through trial design adjustments.
Q & A Highlights
Q: How do the subpopulation and amendments to the planned Phase 3 trial improve results from Phase 2?
A: Victor Chong, Chief Medical Officer, explained that the Phase 3 trial aims to exclude patients with higher variability in disease, which should lead to better results. The Phase 2 trial included difficult-to-treat patients, and moving to a more general population is expected to yield improved outcomes. The subgroup analysis indicated that patients who required fewer treatments performed well, suggesting a higher percentage of such patients in the general population.
Q: How long will it take to enroll the treatment-naive population, and did the FDA require a certain number of patients in each treatment interval?
A: Victor Chong stated that enrollment is expected to take around 12 months. The FDA does not require separate adverse event rates for different groups; the drug will be assessed as a whole. The agency considers the entire arm as one, similar to recent approvals like EYLEA high dose and VABYSMO.
Q: What is the estimated cost of the Phase 3 trial, and can Clearside manage such a large program?
A: Charlie Deignan, CFO, mentioned that while specific costs are not disclosed, similar Phase 3 trials cost around $55 million to $60 million each. Clearside has experience running large trials and plans to use a global CRO to manage the trial.
Q: Why choose two non-inferiority studies instead of a superiority trial?
A: Victor Chong explained that two non-inferiority studies are a proven and tested approach, with the agency having approved multiple drugs based on this method. It is considered less risky than having different trial types, and most retinal drugs have been approved using non-inferiority trials.
Q: What are the financing strategies for the Phase 3 trial, and is the study initiation still planned for the second half of the year?
A: Charlie Deignan confirmed that the study is set to start in the second half of the year, pending funding. Clearside is exploring all options, including potential partnerships, to secure the necessary funds for the trial.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
