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Opthea announces Sozinibercept as the nonproprietary drug name for OPT-302
OPT-302 is the company’s novel recombinant “trap” fusion protein targeting inhibition of vascular endothelial growth factors C and D, two ligand mediators of angiogenesis and vascular leakage involved in retinal vascular diseases.
Opthea Ltd. announced the American Medical Association’s United States Adopted Names (USAN) Council, in consultation with the World Health Organization’s International Nonproprietary Names (INN) Expert Committee, has approved and adopted the nonproprietary drug name “sozinibercept” for the company’s lead biologic drug candidate, OPT-302.
(Image Credit: AdobeStock/weyo)
According to the company, 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.
Moreover, the company noted that OPT-302 is 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).
The company also noted OPT-302 is proprietary to Opthea with issued patents running to at least 2034 and currently pending patents that are expected to extend coverage.
Going forward, Opthea noted in the news release it 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 authorization.
Opthea also announced in its news release it is currently conducting two global pivotal registrational Phase 3 studies, the ShORe trial (NCT04757610)of 2 mg sozinibercept + 0.5 mg ranibizumab, and the COAST (NCT04757636) 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.
