AAO 2023: ShORe and COAST clinical trial updates from Opthea Limited

Megan Baldwin, MD, founder of Opthea Limited, spoke with Ophthalmology Times about the company's ShORe and COAST clinical trials at this year's American Academy of Ophthalmology meeting.

Video Transcript

Editor's note - This transcript has been edited for clarity.

Megan Baldwin, MD:

Hi, everyone. I'm Megan Baldwin, I am Chief Innovation Officer and founder of Opthea Limited. It's great to be here in San Francisco for the AAO meeting and to have attended the Eyecelerator innovation summit yesterday as well. We're really pleased to be here to tell everyone about our Phase III clinical trial program for the treatment of neovascular AMD.

At Opthea, we're developing sozinibercept, or OPT-302, as a novel and differentiated treatment for neovascular AMD, where we're really seeking to improve clinical outcomes for patients. We're all about superiority benefit, and better visual acuity outcomes, with the treatment of sozinibercept on top of any standard of care treatment that targets VEGF-A.

So we're in Phase III clinical development right now. We have 2 clinical trials ongoing, we have a ShORe, Phase III study called ShORe in combination with ranibizumab. We also have a Phase III clinical trial called COAST, which is in combination with aflibercept. Both of those studies are very well advanced. And we are in the last stages of patient recruitment. So we're about 80% enrolled, we expect to be completing enrollment in those clinical trials in the first and second quarter of calendar year 2024. So just a few months to go. We really thank all of our sites, our investigators and the patients that are involved to date with our studies. This is such an important trial for us. We expect to read out data in the first half of calendar year 2025.

So after many years of development, with this molecule that targets VEGF-C and -D, we think that we're getting really close to what will be a very important clinical trial readout for patients, because we really are the most advanced product in development that has the potential to offer patients something, something better, and on top of what is currently available for them so that they can have better vision. So thanks very much everyone, and we hope to keep updating you along the way.