Alpharetta, Georgia-based Clearside develops the SCS Microinjector suprachoroidal injection device. It enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases.
ODYSSEY, a Phase 2b clinical trial, evaluated CLS-AX (axitinib injectable suspension) delivered suprachoroidally for the treatment of neovascular age-related macular degeneration (wet AMD). It compared the treatment to patients receiving aflibercept. Participants who received the Clearside therapy showed stable best corrected visual acuity (BCVA) and ocular anatomy (central subfield thickness) up to six months.
Additionally, the Clearside treatment demonstrated a well-tolerated safety profile to Week 36. That was inclusive of mandatory re-dosing of CLS-AX at Week 24, according to a news release.
The study included 60 total participants randomized to CLS-AX or aflibercept with a 2:1 randomization schedule. The 40 patients receiving CLS-AX had their therapy administered through the SCS Microinjector. Clearside said the remaining 20 received aflibercept through intravitreal injection.
“We are very excited to report positive topline data from our successful ODYSSEY Phase 2b trial,” said George Lasezkay, president and CEO, Clearside Biomedical. “These encouraging results strongly support advancing our CLS-AX wet AMD program into Phase 3 development and provide further evidence of the potential benefits of delivering medicines to the back of the eye using our proprietary SCS Microinjector.
“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.”
