Clearside’s CLS-AX shows promise in treatment of wet age-related macular degeneration

1. Patients with wet age-related macular degeneration receiving CLS-AX achieved stable visual acuity, and retinal thickness for up to six months.

2. 90% of patients on CLS-AX required no additional treatment at the 4-month mark.

The Latest

The ODYSSEY study is a recent Phase 2b clinical trial which investigated the use of Clearside’s axitinib injectable suspension (CLS-AX) in the treatment of wet age-related macular degeneration. The study followed a 2:1 randomization to assess the use of CLS-AX in 40 patients compared to 20 patients receiving standard treatment. The study achieved its primary outcome of improvement in visual acuity, as patients receiving CLS-AX had stable visual acuity for six months. Secondary outcomes, including changes in ocular anatomy and the need for supplemental treatment, were also met. 90% of patients did not require additional treatment at four months, and patients maintained stable retinal thickness at six months.

Physician’s Perspective

Age-related macular degeneration (AMD) is a common condition and a leading cause of vision loss. It occurs when a part of the retina, called the macula, is damaged. This causes a loss of central vision at near and far distances. There are two types of AMD: dry AMD is caused by protein clumping, and thinning of the macula with age, while wet AMD is caused by abnormal blood vessel growth and leakage that damages the retina.

Current treatments for wet AMD involve laser therapy against abnormal blood vessels or medications that reduce the number of blood vessels and the amount of leakage. These medications are called anti-VEGF drugs because they inhibit vascular endothelial growth factor (VEGF), which normally stimulates blood vessel formation. CLS-AX is a novel treatment that blocks three VEGF receptors to provide long-lasting benefits. Compared to existing treatments that require frequent, lifelong injections, CLS-AX may be longer-acting and reduce treatment burden associated with AMD.

Molecular Targets

CLS-AX is an injectable tyrosine kinase inhibitor of VEGF receptors. It binds to a region of the VEGF receptors called the tyrosine kinase domain to block cell signaling. As previously mentioned, VEGF promotes new blood vessel formation, and thus blocking VEGF receptors prevents vessel growth and reduces damage to the macula. Additionally, CLS-AX is administered in a specific way that delivers the drug to the diseased area at the back of the eye. This delivery method, called suprachoroidal injection, ensure higher levels of the drug reach the retina and macula.

Company History

This treatment was developed by Clearside Biomedical. Clearside specializes in developing suprachoroidal injection therapies to treat many different ocular diseases. Their patented SCS Microinjector is the only FDA approved product to administer drugs to the suprachoroidal space. Clearside is also known for Xipere, a suprachoroidal steroid injection approved to treat macular edema. They are also exploring the use of gene therapies to treat wet AMD, with their product ABBV-RGX-314 currently in Phase 2a clinical trials.

Further reading: https://www.sciencedirect.com/science/article/pii/S2666914524001222

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