Ocular Therapeutix, Inc. recently announced an accelerated timeline for its Phase 3 SOL-1 clinical trial evaluating AXPAXLI™ (axitinib intravitreal implant) as a potential treatment for wet age-related macular degeneration (wet AMD). The company now expects to complete participant enrollment and randomization by the end of 2024, moving ahead of the initial projections. With this update, topline results from SOL-1 are anticipated by the fourth quarter of 2025, marking a significant milestone for AXPAXLI as an investigational therapy.
The SOL-1 study, conducted under a Special Protocol Agreement (SPA) with the U.S. FDA, is designed to test AXPAXLI’s effectiveness against aflibercept injections in a superiority trial. Approximately 300 participants will receive two loading doses of aflibercept, after which they’ll be randomized to receive either a single AXPAXLI implant or another aflibercept injection. The primary endpoint is the proportion of patients maintaining visual acuity, defined as a loss of fewer than 15 letters on the ETDRS scale, by Week 36. This faster-than-expected enrollment reflects significant interest from both patients and investigators, as AXPAXLI offers the potential for a reduced treatment burden through sustained dosing.
Ocular Therapeutix’s broader Phase 3 program also includes the SOL-R trial, a complementary non-inferiority study assessing repeat dosing of AXPAXLI. This trial aims to provide additional data on the safety and efficacy of AXPAXLI over a one-year period, comparing it to standard aflibercept treatment and supporting the company’s regulatory filing with the FDA. Together, SOL-1 and SOL-R are expected to build a strong case for AXPAXLI as a viable, longer-lasting treatment option for wet AMD.
Pravin U. Dugel, MD, Executive Chairman, President, and CEO of Ocular Therapeutix, expressed enthusiasm for the accelerated timeline, attributing the trial’s rapid pace to the clinical team’s dedication and strong collaboration with trial sites. Dr. Dugel emphasized AXPAXLI’s potential to shift the treatment paradigm in wet AMD, offering sustained visual improvement with fewer injections.
Retinal specialist Dr. David A. Eichenbaum noted the importance of developing durable treatments for wet AMD. He highlighted that AXPAXLI’s design addresses this need and aligns with FDA requirements, offering a promising alternative to the frequent dosing required by current therapies.
AXPAXLI, also called OTX-TKI, is an investigational, bioresorbable hydrogel implant that delivers axitinib, a tyrosine kinase inhibitor with anti-angiogenic effects. Leveraging the company’s proprietary ELUTYX™ technology, AXPAXLI is designed to provide a sustained release within the eye, addressing the limitations of repeated injections in current wet AMD treatments. This technology also underpins Ocular’s FDA-approved DEXTENZA® implant for post-surgical inflammation and its investigational PAXTRAVA™ implant for glaucoma, reflecting the company’s commitment to innovative ocular therapies.
With its expanded pipeline, Ocular Therapeutix is poised to bring transformative solutions to ophthalmic care, with AXPAXLI as a potential breakthrough for wet AMD treatment.
Further reading:
MADHOOSUDAN PATIL, Chintan Patel, Erica Kahn, Joe Iacona, Daniel Domingues, Alyssa Whalen, Charles Blizzard, Olivia Sherman, Mark Ransbottom, Dinesh Haswani, Rabia Gurses Ozden, Peter Jarrett; Optimized pharmacokinetic profile of intravitreal axitinib intravitreal implant (Axpaxli™): a comparison of first- and second-generation implants. Invest. Ophthalmol. Vis. Sci. 2024;65(7):1937.
Rowe, Lucas W., and Thomas A. Ciulla. 2024. “Long-Acting Delivery and Therapies for Neovascular Age-Related Macular Degeneration.” Expert Opinion on Biological Therapy 24 (8): 799–814. doi:10.1080/14712598.2024.2374869.