Opthea’s lead biologic drug candidate OPT-302, which is under investigation for the treatment of wet AMD, received nonproprietary drug name sozinibercept, which is a critical step in the FDA approval process.
Opthea announced that its lead biologic drug candidate OPT-302—which is being evaluated in 2 Phase 3 clinical trials for the treatment of neovascular or wet age-related macular degeneration (wet AMD)—has received its nonproprietary drug name: Sozinibercept (pronounced soe'' zi nib' er sept). Alongside the World Health Organization’s International Nonproprietary Names (INN) Expert Committee, the American Medical Association’s United States Adopted Names (USAN) Council approved and adopted the name to describe Opthea’s novel recombinant “trap” fusion protein targeting inhibition of vascular endothelial growth factors C and D (VEGF-C and VEGF-D). The drug is administered via intravitreal injection.
Going forward, sozinibercept will be the official moniker of OPT-302, which holds fast track designation from the US Food and Drug Administration (FDA). Its 2 Phase 3 studies, ShORe (investigating 2 mg sozinibercept + 0.5 mg ranibizumab) and COAST (investigating 2 mg sozinibercept + 2 mg ranibizumab) are ongoing. Both share a primary end point: Superiority in visual acuity gains at 12 months for combination therapy when compared with standard-of-care monotherapy.
Global standardization and unification of drug nomenclature classifications based on pharmacological and/or chemical relationships communicate clear and accurate information. This is regulated by the USAN council, which is sponsored by the American Medical Association, the United States Pharmacopeia, and the American Pharmacists Association. Standardization of drug nomenclature classifications is done in conjunction with the INN Program and in consultation with various national nomenclature groups.
Effective immediately, sozinibercept will be used in upcoming publications, public statements, conference presentations, corporate materials, and any other proprietary communications from Opthea. As they continue on the journey toward commercialization of sozinibercept for the treatment of wet AMD and other indications, Opthea is also pursuing a formal global proprietary brand name for sozinibercept in pursuit of marketing authorization. Regulatory approval of adopted drug names is a critical step in this process.
Opthea retains the proprietary hold on sozinibercept via patents that extend until 2034 and pending patents that may lengthen the timeline. For more information on the ShORe and COAST clinical trials, please visit Opthea's website or clinicaltrials.gov.