Expanded Access Position Statement
At the current time, and in accordance with Opthea’s Expanded Access Policy, OPT-302 is not available for expanded access for the following reasons:
- OPT-302 is an investigational product and is not approved for any indication in any market worldwide. OPT-302 is currently under investigation for Age-Related Macular Degeneration and Diabetic Macular Edema to determine if combination treatment of OPT-302 with standard of care anti-VEGF-A therapy has greater benefit than standard of care alone. It is not possible to determine whether addition of OPT-302 to anti-VEGF-A therapy has an improved benefit over standard of care treatment until completion of Phase 3 clinical trials.
- Providing expanded access may interfere with clinical trial supply availability.
A copy of Opthea’s Expanded Access Policy is available here.
Additional information on Opthea’s technology and clinical trials can be found at ClinicalTrials.gov (ShORe trial, ID#: NCT04757610; COAST trial, ID#: NCT04757636).