Ocular Therapeutix Secures FDA Nod for Modified Axpaxli Clinical Trial in Wet AMD

Ocular Therapeutix announced that the FDA has granted approval for a modification to the special protocol assessment (SPA) agreement for the pivotal phase 3 SOL clinical trial of Axpaxli (axitinib intravitreal implant, also known as OTX-TKI). This modification marks a significant development in the pursuit of an innovative treatment for wet age-related macular degeneration (AMD).

The SPA agreement modification is designed to expedite the enrollment process for the SOL trial by including treatment-naïve wet AMD subjects with visual acuity of approximately 20/80 or better at the initial screening visit.

Eligible participants must undergo two aflibercept injections in the screening period and subsequently gain at least 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters from the initial screening visit to Day 1, or achieve a visual acuity of approximately 20/20 or better at Day 1, among other criteria, to qualify for enrollment in the trial.

Moreover, the modification allows the pivotal trial to progress with the evaluation of AXPAXLI using a single optimized implant with a drug load of 450 µg of a more soluble form of axitinib. This configuration is expected to result in a slightly increased daily release of the drug, aiming to enhance the synchronization of axitinib drug depletion with hydrogel bioresorption, according to statements from Ocular Therapeutix.

Antony Mattessich, CEO of Ocular Therapeutix, expressed enthusiasm about the SPA agreement modification, stating in a company news release, “With the changes reflected in the SPA agreement modification agreed to by the FDA, we believe we can accelerate the enrollment process for the SOL trial." Mattessich emphasized the close collaboration between Ocular Therapeutix and the FDA to ensure that the SOL trial aligns with the agency’s updated guidance for wet AMD clinical trials.

Axpaxli, the focal point of the clinical trial, is an investigational bioresorbable hydrogel implant that incorporates axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties. The treatment is being evaluated not only for wet AMD but also for other retinal diseases.