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 (nAMD). 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 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 nAMD 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.

“Our interactions with the FDA have been very positive and productive and we are aligned on our proposed phase 3 program," commented Chief Medical Officer Victor Chong, MD, MBA.  "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.” RP