Ocular Therapeutix Inc screens first 3 patients in Phase 3 SOL-1 trial

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Ocular Therapeutix Inc. screened the first 3 subjects in the Phase 3 SOL-1 clinical trial of AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD). These 3 participants have also received their first aflibercept injection.¹

This trial commencement comes after the company announced FDA agreement on its Special Protocol Assessment (SPA) Agreement Modification on January 25, 2024.

In the news release¹, Antony Mattessich, CEO of Ocular Therapeutix, shared the importance of this trial and how it could impact the future of wet AMD treatment, saying, “The screening of these subjects in the pivotal Phase 3 SOL-1 trial of AXPAXLI marks an exciting milestone for Ocular Therapeutix. AXPAXLI has demonstrated promising durability, biological activity, and a favorable safety profile in earlier studies. We believe that AXPAXLI could set a new standard in wet AMD therapy by significantly extending time between treatments. If successful, this first-of-its-kind implant could reduce injection burden for patients and doctors alike while leading to better long-term outcomes.”

Allen Hu, MD, is a principal investigator in the SOL study and vitreoretinal surgeon at Cumberland Valley Retina Consultants. In the press release¹, he noted that reducing treatment burden for patients is key to effective treatment. He said, “Wet AMD patients need options that provide sustained therapy while minimizing their need for frequent injections and office visits. I am thrilled to be participating in research that could shift the existing treatment paradigm for patients with wet AMD.” The company highlighted that Hu is an active principal investigator of innovative technologies for the treatment of macular degeneration, diabetic retinopathy and retinal vascular disorders, having participated in over 40 clinical trials over the past 10 years.

Dilsher Dhoot, MD, is another respected principal investigator in the SOL-1 study and vitreoretinal surgeon at California Retina Consultants. Dhoot has contributed to over 35 clinical trials in the past decade as an active principal investigator, pioneering new approaches in advancing the field of retinal therapies. In a statement the company published1, Dhoot is quoted saying, “Clinical trials like the SOL-1 study for AXPAXLI represent a critical step forward in our pursuit of more patient-centric treatments for wet AMD. As a clinician dedicated to advancing retinal care, I am excited to contribute to the development of potentially transformative solutions for our patients.”

About AXPAXLI

AXPAXLI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and other retinal diseases.¹

Reference:

1. Ocular Therapeutix™ Announces First Subjects Screened in Phase 3 Pivotal Clinical Trial of AXPAXLI™ in Wet AMD. Ocular Therapeutix, Inc. Published February 13, 2024. Accessed February 13, 2024. https://www.biospace.com/article/releases/ocular-therapeutix-announces-first-subjects-screened-in-phase-3-pivotal-clinical-trial-of-axpaxli-in-wet-amdphase-3-sol-1-study-will-evaluate-the-efficacy-and-safety-of-axpaxli-in-wet-amd/