SOL-1 Phase 3: Trial Design, Efficacy, and Rescue Treatment Outcomes in Neovascular AMD

In this opening segment, Dr. Arshad Khanani highlights the SOL-1 phase 3 trial evaluating Axpaxli (OTX-TKI) in treatment-naïve neovascular AMD. Patients entered at peak visual acuity after two aflibercept loading doses and required strong early vision response before randomization—an important distinction from prior trials. Conducted under FDA Special Protocol Assessment, both arms followed identical dosing without sham injections, aligning with current regulatory guidance. SOL-1 is the first superiority trial versus aflibercept 2 mg on equal dosing. At week 36, 74.1% of Axpaxli patients maintained vision versus 55.8% with aflibercept, with durability through week 52 (65.9% vs. 44.2%). Dr. Khanani highlights anatomic outcomes as clinically meaningful, showing stronger CSFT control with Axpaxli. Rescue-free rates were higher and time to first rescue significantly delayed. Fluid control data further support sustained disease suppression, underscoring Axpaxli’s durability and reduced treatment burden over 9–12 months.

This video series has been produced independently by Ophthalmology Times and supported by Ocular Therapeutix. The following presentation discusses OTX-TKI - an investigational product candidate that has not been approved by the FDA or any other regulatory body