Relevant to Our
Pipeline and Science

Opthea, Ltd. (Opthea) is a biopharmaceutical company developing medicines for people living with serious retinal diseases. Our goal is to provide access to our investigational medicines at the appropriate time and in a safe manner.

Clinical trials to evaluate the safety and effectiveness of our potential new medicines are an essential and required step before we can seek review and potential approval by the Food and Drug Administration (FDA) or other regulatory agencies.

In certain circumstances, people living with a serious or immediately life-threatening disease or condition may gain access to an investigational medicine outside of clinical trials when no comparable or satisfactory alternative therapy options are available. This potential pathway is known as “Expanded Access” and sometimes also called “Pre-approval Access”, “Named Patient Access” or “Compassionate Use.”

At this time, Opthea does not provide access to our investigational products outside of enrollment in clinical trials. Our goal is to provide access to our investigational medicines at the appropriate time and in a safe manner. We believe enrollment in our ongoing clinical trials is the most effective way of achieving this goal.

Therefore, we are unable to provide investigational medicines via expanded access programs and we do not currently accept or grant any requests for expanded access to any of our investigational medicines outside of our clinical trial programs.

We reserve the right to revise this policy at any time in accordance with the US 21st Century Cures Act and applicable global regulations.

If you have questions about our clinical trials, please speak with your health care provider. If you have additional questions about this policy or about Opthea, please contact the team at [email protected]. You may also learn more about Opthea’s ongoing clinical programs by visiting clinicaltrials.gov (COAST, NCT04757636, and ShORe, NCT04757610).

Opthea will make every effort to respond to questions within five (5) business days of receipt.