BEDFORD, Mass. - Ocular Therapeutix, Inc. (NASDAQ:OCUL) has reached a significant milestone in the development of its innovative wet age-related macular degeneration (wet AMD (NASDAQ:AMD)) therapy, AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI). The company announced Monday that the first three participants in the Phase 3 SOL-1 clinical trial have been screened and administered their initial dose of aflibercept, a standard of care anti-VEGF therapy.
This trial follows the FDA’s agreement on a Special Protocol Assessment (SPA) Agreement Modification on January 25th. The SOL-1 study is pivotal for AXPAXLI, which has shown potential in earlier studies for its durability, biological activity, and safety profile. The bioresorbable, hydrogel-based implant is designed to release medication over an extended period, potentially reducing the frequency of treatments for patients.
CEO Antony Mattessich expressed optimism about AXPAXLI’s ability to improve the current treatment standard for wet AMD by significantly extending the time between treatments, thus reducing the burden on patients and healthcare providers. The current treatment for wet AMD involves regular intraocular injections, which AXPAXLI aims to replace with its long-acting implant.
The SOL-1 study is part of ongoing efforts to find more patient-centric treatments for wet AMD, a leading cause of severe, irreversible vision loss worldwide. Dr. Allen Hu and Dr. Dilsher Dhoot, both principal investigators in the SOL-1 study, highlighted the importance of advancing retinal care and the potential impact of AXPAXLI on the treatment paradigm for wet AMD.
Ocular Therapeutix is known for its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™, and its FDA-approved corticosteroid, DEXTENZA®, for treating ocular inflammation and pain following ophthalmic surgery. The company’s product pipeline includes treatments for diabetic retinopathy, glaucoma, and dry eye disease, all in various stages of clinical development.
While the press release includes forward-looking statements, it is important to note that the outcomes of clinical trials are uncertain, and the FDA’s approval for marketing is not guaranteed. The information in this article is based on a press release statement from Ocular Therapeutix, Inc.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.