Clearside Biomedical (CLSDQ) Stifel 2024 Healthcare Conference summary

Key clinical insights and trial design

• Completed phase II-B Odyssey trial in wet AMD, enrolling patients with active disease and demonstrating competitive efficacy, especially in a harder-to-treat population.

• Demonstrated safe and effective repeat dosing, distinguishing from competitors who have not attempted multiple dosing in phase II.

• Flexible dosing strategy aims for a label allowing dosing every three to six months, aligning with real-world clinical needs.

• Retreatment criteria in Odyssey were more stringent and closer to clinical practice, with plans to further refine criteria based on fluid type for phase III.

• Dropout rates were low, under 10% at six months and 12-15% at nine months, with slightly higher rates in the comparator arm.

Competitive positioning and market strategy

• Efficacy data at six months is comparable or superior to competitors, with added flexibility for earlier redosing if needed.

• Flexible dosing (three to six months) is seen as a commercial advantage, allowing physicians to tailor treatment intervals.

• Competitors are locked into fixed six-month dosing with rescue options, potentially increasing costs and limiting flexibility.

• Moving to a treatment-naive population in phase III is expected to broaden commercial potential and demonstrate efficacy in a wider patient base.

• Exploring a range of financing options, including partnerships, for late-stage development and commercialization.

Suprachoroidal delivery and safety profile

• Suprachoroidal delivery is gaining adoption, with multiple products and partners advancing in development.

• Procedure is only marginally longer than intravitreal injection and is compensated by a higher CPT code.

• Over 10,000 injections performed with no cases of endophthalmitis, a key safety advantage over intravitreal delivery.

• Competitors using intravitreal delivery have reported cases of endophthalmitis.

• Suprachoroidal delivery leverages immune surveillance in the choroidal space, reducing infection risk.