Retinal disease treatment developer Opthea Limited (ASX:OPT) has received official international approval for the adoption of the non-proprietary drug name “sozinibercept” for the company’s lead biologic drug candidate, OPT-302.
Sozinibercept (OPT-302) is the company’s novel recombinant “trap” fusion protein targeting inhibition of vascular endothelial growth factors C and D (VEGF-C and VEGF-C), two ligand mediators of angiogenesis and vascular leakage involved in retinal vascular diseases. Sozinibercept administered by intravitreal injection in combination with standard of care anti-VEGF-A therapy is currently being evaluated in two Phase 3 clinical trials for the treatment of neovascular (wet) age-related macular degeneration, for which it holds fast track designation from the U.S. Food and Drug Administration (FDA).
Sozinibercept is proprietary to Opthea with issued patents running to at least 2034 and currently pending patents that are expected to extend coverage.
The USAN Council (tri-sponsored by the American Medical Association, the United States Pharmacopeia, and the American Pharmacists Association), together with the INN Program of the World Health Organisation and in consultation with various national nomenclature groups, aims for global standardisation and unification of drug nomenclature classifications based on pharmacological and/or chemical relationships, to ensure clear and accurate communication of drug information.
Going forward, Opthea will use the name sozinibercept in upcoming publications and public statements, at conferences and other forums, and in corporate-related materials as the company continues to advance the clinical development toward commercialization of the product in wet AMD and other indications. The company is also pursuing a formal global proprietary brand name for sozinibercept. Obtaining regulatory approval of these adopted drug names is a necessary step for marketing authorisation.
Opthea is currently conducting two global pivotal registrational Phase 3 studies, the ShORe trial of 2 mg sozinibercept + 0.5 mg ranibizumab, and the COAST trial of 2 mg sozinibercept + 2 mg aflibercept. The primary endpoint for both studies is superiority in visual acuity gains at 12 months for the combination therapy compared with standard-of-care monotherapy.
