Clearside Biomedical announced that David M. Brown, MD, delivered a presentation entitled, “Axitinib: A Novel TKI Delivered by Suprachoroidal Injection for AMD” at the virtual Angiogenesis, Exudation, and Degeneration 2021 program hosted by the University of Miami Health System Bascom Palmer Eye Institute on February 12-13, 2021.
Dr. Brown’s presentation highlighted several of the key attributes of axitinib and Clearside’s suprachoroidal delivery of the agent, including the ease of administration as demonstrated in a video of a clinical trial patient undergoing the office-based suprachoroidal delivery procedure. In preclinical studies, axitinib showed intrinsic high potency, pan-VEGF inhibition through receptor blockade versus focused VEGF-A inhibition seen in currently marketed anti-VEGF treatments. Axitinib is a highly potent tyrosine kinase inhibitor (TKI) that has been observed preclinically to be greater than ten times more potent than other TKIs, and inhibits and regresses angiogenesis.
Suprachoroidal delivery of Clearside’s proprietary, injectable suspension of axitinib, known as CLS-AX, has produced up to 11 times higher drug levels in affected tissues than intravitreal administration of axitinib in preclinical models. This compartmentalized delivery to affected posterior tissues may minimize treatment related adverse events, such as vitreous floaters and corneal and anterior segment exposure. With the prolonged duration observed in pharmacokinetic studies, this targeted treatment approach also has the potential to reduce treatment burden for patients.
“We appreciate Dr. Brown’s thorough presentation which highlighted the potential of axitinib and CLS-AX to improve the treatment landscape for the millions of patients suffering from wet AMD,” Thomas A. Ciulla, MD, MBA, Chief Medical Officer and Chief Development Officer, said in a company news release. “By combining the high potency and pan-VEGF attributes of axitinib with our proprietary CLS-AX formulation and delivery via our SCS Microinjector, we believe we can achieve clinical adoption of this technique by the retina community and improve the overall patient experience with a longer lasting treatment that may reduce or eliminate the challenging side effects seen with other agents. Our phase 1/2a OASIS clinical trial in wet AMD is an ongoing US-based, multicenter, open-label, dose-escalation, safety and tolerability study. We expect to report initial safety data from the first OASIS cohort mid-year 2021.”
About CLS-AX (axitinib injectable suspension)
CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effects with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD. CLS-AX is currently being investigated in an ongoing US-based, multi-center, open-label, dose-escalation, Phase 1/2a, safety and tolerability study, entitled OASIS, in wet AMD patients, and additional information can be found on https://clinicaltrials.gov (NCT04626128).