Opthea to Receive US$35M Commitment and Additional US$50M Funding - Seite 2

About sozinibercept

Sozinibercept (OPT-302) is a soluble form of vascular endothelial growth factor receptor (VEGFR)-3 expressed as an immunoglobulin G1 (IgG1) Fc-fusion protein. It binds and neutralizes the activity of vascular endothelial growth factor (VEGF)-C and VEGF-D on their endogenous receptors, VEGFR-2 and VEGFR-3. Targeted inhibition of VEGF-C and VEGF-D can prevent blood vessel growth and vascular leakage, which contribute to the pathophysiology of retinal diseases including neovascular “wet” AMD.

About ShORe and COAST Phase 3 Clinical Studies

Opthea currently is enrolling patients for its two ongoing concurrent Global pivotal Phase 3 clinical trials for the treatment of wet AMD. The multi-center, double-masked, sham-controlled Phase 3 ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study;) clinical trials will each enroll approximately 990 treatment-naïve patients and assess the efficacy and safety of intravitreal 2.0 mg sozinibercept in combination with 0.5 mg ranibizumab (Lucentis) (ShORe trial) or 2.0 mg aflibercept (Eylea) (COAST trial), compared to ranibizumab or aflibercept monotherapy, respectively. In addition, extended durability of the sozinibercept treatment effect on clinical outcomes with less frequent every eight-weekly dosing will be compared with sozinibercept administered on an every four-weekly dosing regimen, in combination with each VEGF-A inhibitor. If successful, the investigation of sozinibercept in combination with two approved standard of care VEGF-A inhibitors in the Phase 3 program could enable sozinibercept to be administered with either Eylea or Lucentis which had combined sales for retinal diseases of >USD$12 billion in 2022. The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity from baseline to week 52 for sozinibercept combination therapy compared to anti-VEGF-A monotherapy. Patients will continue to be treated for a further year to evaluate extended safety and tolerability over a two-year period. To learn more, visit www.opthea.com and ClinicalTrials.gov (ShORe trial, ID#: NCT04757610; COAST trial, ID#: NCT04757636).