Clearside Biomedical's Phase IIb ODYSSEY study of CLS-AX (axitinib injectable suspension) has achieved its primary and secondary endpoints in patients with neovascular age-related macular degeneration (wet AMD). The study suggests that CLS-AX, in combination with Clearside's SCS Microinjector, could offer a less burdensome treatment option compared to the current standard of care. The trial's success paves the way for Phase III development.
Innovative Delivery Method
CLS-AX is administered into the suprachoroidal space of the eye using Clearside's SCS Microinjector. This targeted delivery method aims to minimize invasiveness and maximize drug concentration at the affected tissues. The suprachoroidal space is the area between the sclera and choroid, allowing for compartmentalized delivery of therapies to the macula, retina, or choroid.
ODYSSEY Trial Results
The ODYSSEY study (NCT05891548) compared CLS-AX to Regeneron's Eylea (aflibercept) in 60 wet AMD patients previously treated with Eylea. Patients were randomized 2:1, with 40 receiving CLS-AX and 20 continuing on Eylea for 36 weeks. The results indicated that patients treated with CLS-AX maintained stable visual acuity and central subfield thickness for six months. Notably, CLS-AX reduced injection frequency by 84%, with 67% of patients requiring no additional injections before mandatory re-dosing at six months. At the four-month mark, 90% of patients needed no further treatment.
Safety and Tolerability
CLS-AX demonstrated a favorable safety profile throughout the 36-week study, including after mandatory re-dosing at Week 24. There were no serious ocular or treatment-related adverse events reported.
Expert Commentary
Clearside’s CEO George Lasezkay stated that the data supports advancing the CLS-AX wet AMD program into Phase III development. "We believe this data supports our goal to potentially provide a safe, convenient wet AMD treatment option with the advantage of a flexible maintenance dosing regimen between 3 to 6 months," added Lasezkay.
Victor Chong, MD. MBA, chief medical officer of Clearside, noted that CLS-AX demonstrated extended duration and stable vision and anatomic measures throughout the trial in a difficult-to-treat patient population with reading center confirmed active disease early in their treatment journey.
Market Implications
Wet AMD is a leading cause of vision loss in individuals over 55. Current treatments, like Eylea, often require frequent injections, posing a burden for patients. Clearside aims to provide a new and important treatment option with meaningful efficacy, safety, and delivery benefits for patients and retina specialists.
Future Directions
Clearside is preparing for a Phase 3 program and plans to share further data at upcoming medical meetings. The company believes the ability to deliver multiple doses as needed between 12 and 36 weeks is a key differentiator from other treatments in development.
