Clearside Biomedical (CLSDQ) Oppenheimer 35th Annual Healthcare Life Sciences Conference 2025 summary

Strategic focus and technology leadership

• Leading in suprachoroidal drug delivery with over 15,000 safe injections using proprietary SCS Microinjector.

• Achieved first FDA approval for suprachoroidal delivery (XIPERE for uveitic macular edema).

• Growing interest from retinal specialists and pharma in suprachoroidal approaches.

• Internal pipeline centers on small molecules for retinal diseases, including wet AMD and geographic atrophy.

• External partnerships with Bausch + Lomb, AbbVie, and REGENXBIO leverage SCS Microinjector for broader applications.

CLS-AX program and clinical development

• CLS-AX, a suprachoroidal axitinib, is phase 3 ready for wet AMD after positive phase 2b Odyssey results.

• Phase 2b showed strong durability, vision stabilization, and positive safety with redosing.

• Phase 3 will feature two concurrent non-inferiority trials with flexible dosing every 3–6 months.

• FDA alignment achieved; primary endpoint at 52 weeks, aiming for a flexible dosing label.

• Flexible dosing differentiates CLS-AX from other TKIs, reducing need for rescue treatments.

Competitive landscape and differentiation

• Flexible dosing (3–6 months) is a key differentiator over other TKIs and biologics like EYLEA HD and VABYSMO.

• No endophthalmitis reported in 15,000+ injections, offering a safety advantage.

• Suprachoroidal delivery avoids floating particles in the eye and does not require refrigeration.

• Market experience shows flexibility drives physician preference and market success.