PUBLICATIONS
AND PRESENTATIONS

Relevant to Our
Pipeline and Science

Our Publications

Ophthalmology Science I March 2025

Sozinibercept (anti-VEGF-C/D) combined with ranibizumab for polypoidal choroidal vasculopathy: Phase 2b predefined subgroup analysis

Chui Ming Gemmy Cheung, FRCOphth, Timothy L. Jackson, PhD, MB ChB, FRCOphth, Charles C. Wykoff, MD, PhD, Arshad M. Khanani, MD, MA, FASRS, Ian M. Leitch, PhD, Megan E. Baldwin, PhD, Jason Slakter, MD

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Ophthalmic Surgery Lasers and Imaging Retina (OSLIR) I February 2025

Sozinibercept Combination Therapy for Neovascular Age-related Macular Degeneration: Phase 2b Study Subgroup Analysis by Lesion Type

Charles C. Wykoff, MD, PhD , Timothy L. Jackson, PhD, MB ChB , Clare F. Price, BPharm , Megan E. Baldwin, PhD , Ian M. Leitch, PhD , and Jason Slakter, MD

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Translational Vision Science and Technology I December 2024

Phase 1b Dose Escalation Study of Sozinibercept Inhibition of Vascular Endothelial Growth Factors C and D With Aflibercept for Diabetic Macular Edema

David S. Boyer, MD, Nathan Steinle, M.D. Joel A. Pearlman, MD, PhD, Cameron M. Stone, MD, Courtney Crawford, MD, Sunil Gupta, MD, Pravin U. Dugel, MD, Megan Baldwin • PhD, MAICD, Ian M. Leitch, MD

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Ophthalmology and Therapy I June 2024

Vascular Endothelial Growth Factor C and D Signaling Pathways as Potential Targets for the Treatment of Neovascular Age-Related Macular Degeneration: A Narrative Review

Ian M. Leitch, Michael Gerometta, David Eichenbaum, Robert P. Finger, Nathan C. Steinle & Megan E. Baldwin

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Expanded Access Policy

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.

“Superior vision empowers individuals and their families to pursue their passions and focus on life’s brilliance. At Opthea, we are dedicated to pioneering innovation by pushing the boundaries of what’s possible to improve sight.”