Advertisment

Ocular Therapeutix Initiates Phase 3 SOL-1 Clinical Trial of Axpaxli for Wet Age-Related Macular Degeneration

author-image
Mason Walker
New Update
NULL

Ocular Therapeutix Initiates Phase 3 SOL-1 Clinical Trial of Axpaxli for Wet Age-Related Macular Degeneration

Advertisment

Ocular Therapeutix, a biopharmaceutical firm dedicated to the development of innovative therapies for eye diseases and conditions, has embarked on the Phase 3 SOL-1 clinical trial of Axpaxli, an investigational axitinib intravitreal implant for the treatment of wet age-related macular degeneration (wet AMD). The trial has enrolled and screened its first three participants, who have received an aflibercept injection as the initial step in the investigation of Axpaxli's efficacy and safety.

Advertisment

Understanding Axpaxli and Its Potential

Axpaxli is a bioresorbable, hydrogel implant that incorporates axitinib, a multi-target tyrosine kinase inhibitor with anti-angiogenic properties. The axitinib component is being researched for its potential in treating wet AMD and other retinal diseases. This innovative solution stands out because of its promising durability, biological activity, and favorable safety profile, according to Antony Mattessich, CEO of Ocular Therapeutix.

The main goal of the trial and the development of Axpaxli is to reduce the burden of frequent injections and office visits for patients with wet AMD. This approach aims to lead to better long-term outcomes for patients while also easing the workload for healthcare providers.

Advertisment

Challenges with Current Wet AMD Therapies

The treatment of wet AMD, a leading cause of severe irreversible vision loss, currently poses several challenges. It affects about 14 million individuals globally, with 1.6 million cases in the United States alone. Existing therapies often require repeated intraocular injections, which can lead to treatment-related adverse events, problems with patient compliance, and sometimes a lack of vision improvement.

Special Protocol Assessment Modification

Advertisment

The U.S. Food and Drug Administration (FDA) has agreed to a special protocol assessment modification of the SOL-1 trial. This modification allows the inclusion of treatment-naïve patients with wet AMD and baseline visual acuity of at least 20/80. This initiative is expected to accelerate the enrollment process, marking a significant milestone for Ocular Therapeutix.

First Commercial Drug Product

It's noteworthy that Ocular Therapeutix's first commercial drug product, DEXTENZA, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery, as well as ocular itching associated with allergic conjunctivitis. The company also has other assets in earlier stages of development for the treatment of primary open angle glaucoma, ocular hypertension, chronic dry eye disease, and short-term treatment of dry eye disease symptoms.

Experts Optimistic About the Trial

Principal investigator Allen Hu, MD, expressed optimism about the trial and emphasized the need for sustained therapy options with a minimized need for frequent injections and office visits for wet AMD patients. Other experts, including Dilsher Dhoot, also underscored the significance of reducing treatment burdens for patients. CEO Antony Mattessich believes that Axpaxli could set a new standard in wet AMD therapy by significantly extending the time between treatments and reducing the injection burden for both patients and doctors.

Advertisment
Chat with Dr. Medriva !