Clearside Biomedical announced the receipt of the formal meeting minutes from its recent End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) relating to CLS-AX (axitinib injectable suspension) for the treatment of neovascular age-related macular degeneration (wet AMD). CLS-AX combines the flexible dosing of a biologic with the longer duration of a tyrosine kinase inhibitor (TKI) and is administered via suprachoroidal injection utilizing Clearside’s patented SCS Microinjector, the company said in a press release. 

The meeting and formal minutes confirmed key elements for 2 proposed phase 3, non-inferiority, pivotal trials, including agreement on the protocol design, patient population, primary and secondary endpoints, and use of sham injections.

The CLS-AX proposed phase 3 program highlights includes:

• Two concurrent, pivotal non-inferiority trials with a primary study endpoint of average change in best-corrected visual acuity (BCVA) from baseline at Week 52, which ensures participants receive multiple doses of CLS-AX;
• Each trial will have 2 arms with ~225 participants per arm comparing CLS-AX (1 mg) to aflibercept (2 mg);
• Enrollment of treatment naïve participants, which represents a broader set of the general wet AMD population and enables quicker recruitment;
• Optimization of study population to reduce variability by using tight screening criteria and eliminating participants with highly variable visual acuity prior to randomization;
• Use of detailed re-dosing criteria for CLS-AX to minimize need for rescue treatment; and
• One-year safety follow up period to meet the registration requirement to submit 2 years of safety data.

“We are pleased to report the positive outcome of our End-of-Phase 2 meeting with the FDA,” said George Lasezkay, PharmD, JD, president and chief executive officer, in the press release. “With a positive safety profile, extended duration, and proven re-dosing capability, CLS-AX has the potential to provide a compelling alternative in the $12+ billion wet AMD market. We look forward to highlighting our proposed phase 3 program during our upcoming earnings call later this month.”

Victor Chong, MD, MBA, chief medical officer and EVP, Head of Research and Development, also commented, “Our interactions with the FDA have been very positive and productive and we are aligned on our proposed phase 3 program. Recognizing that wet AMD patients require individualized treatment schedules, our proposed Phase 3 trials are designed to support a flexible maintenance dosing label of CLS-AX for every 3 to 6 months as needed based on patient disease assessments by the physician.”