Clearside Biomedical (CLSDQ) Stifel 2025 Virtual Ophthalmology Forum summary

Platform and partnership strategy

• Focused on delivering therapeutics to the suprachoroidal space using a proprietary injection device, validated through multiple partnerships.

• Commercialization partnerships established for XIPERE in the US and Pan-Asia, with recent expansion via Santen Pharmaceuticals.

• Strong intellectual property portfolio covers device design, manufacturing, and drug delivery applications.

Clinical development and product differentiation

• CLS-AX (axitinib) for wet AMD completed phase II-B (Odyssey trial) and is considered phase III-ready with flexible dosing.

• CLS-AX offers dosing flexibility (three to six months) to accommodate patient variability, aiming for most patients to achieve six-month intervals.

• Phase II data show no ocular serious adverse events and robust efficacy, with redosing experience providing a safety advantage over competitors.

• Phase III trial designed for two years with a primary endpoint at 52 weeks, using a non-inferiority approach and optimized inclusion criteria to reduce variability.

Suprachoroidal delivery acceptance and benefits

• Over 15,000 injections performed and 100+ peer-reviewed publications support the procedure's safety and efficacy.

• Suprachoroidal injection is less invasive than intravitreal, with increasing physician acceptance and minimal learning curve.

• Major benefit includes reduced risk of endophthalmitis compared to intravitreal injections.