Clearside Biomedical ( NASDAQ: CLSD ) added ~12% pre-market Thursday after announcing that CLS-AX, the company's axitinib suspension for suprachoroidal injection, reduced the need for additional therapies in patients with wet AMD.
The findings were based on six-month data from its OASIS Phase 1/2a clinical trial, which tested a single dose of CLS-AX administered by suprachoroidal injection via the company's SCS Microinjector.
The open-label trial for four dose levels of investigational therapy comprised 27 patients who received Regeneron's ( REGN ) Wet AMD therapy Eylea at the first visit, followed by a single dose of CLS-AX at the second visit one month later.
Final extension data indicated that 67% of participants didn't require additional treatment for at least six months, and 50% went beyond six months without further treatment. Additionally, the company said CLS-AX was well tolerated and indicated an excellent safety profile across all doses and time points.
The company intends to start a randomized, double-masked Phase 2b trial called ODYSSEY for CLS-AX in Q1 2023, with its primary endpoint readout expected in mid-2024.
In November, Clearside ( CLSD ) posted 3-month data from the OASIS study.
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Clearside gains 12% as eye disease therapy cuts need for additional treatment