Texas Retina’s Lori E. Coors, MD, recently enrolled and treated the first patient in the Phase III DAYBREAK trial evaluating an intravitreal tarcocimab tedromer and tabirafusp tedromer compared with intravitreal aflibercept in participants with neovascular (wet) age-related macular degeneration (AMD).
Tarcocimab is an investigational anti-VEGF inhibitor built on a proprietary antibody biopolymer conjugate (ABC) platform. It was designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents. Tabirafusp is an investigational molecule with two different targets associated with retinal diseases, VEGF and IL-6, with the hope of having better outcomes for patients. Tabirafusp is also built on the ABC platform.
Wet AMD Treatment Challenges
A leading cause of vision loss in people over the age of 50, AMD happens when the macula, the central part of the retina responsible for detailed vision tasks, is damaged. With wet AMD, an advanced form of the condition, abnormal blood vessels grow into the macular retina, leaking blood or fluid. This can lead to potentially severe vision loss. Wet AMD is a lifelong disease that requires continuous treatment to help patients maintain visual function.
While there are numerous treatments available for wet AMD, challenges still exist. Anti-VEGF injections are the standard of care and must be dosed on average every two months.
“The wet AMD treatments we currently have available require frequent dosing, which can be a burden for many patients,” explains Dr. Coors. “At Texas Retina, we continue to research the safety and efficacy of potential new options designed to extend the time between treatments while continuing to prevent disease progression and associated vision loss.”
About the DAYBREAK Study
Launched in August 2024, the DAYBREAK study includes investigational arms for the tarcocimab tedromer and the tabirafusp tedromer to evaluate their efficacy, safety and durability versus aflibercept. It builds off the Phase III DAYLIGHT trial, a randomized, double-masked, active comparator-controlled study that evaluated the efficacy and safety of a high intensity dosing regimen of tarcocimab tedromer in 557 treatment-naïve subjects with wet AMD. The DAYLIGHT study met the primary endpoint of non-inferior visual acuity gains for tarcocimab dosed monthly compared to aflibercept dosed every 8 weeks following 3 monthly loading doses. In addition, tarcocimab was safe and well tolerated in the DAYLIGHT study and had a low rate of intraocular inflammation.
Dr. Coors serves as a Principal Investigator for the DAYBREAK trial in Texas Retina’s Plano office. In addition, Wayne A. Solley, MD, serves as a Principal Investigator in Arlington, and Patrick D. Williams, MD, in Fort Worth.
“We are excited to be the first in the country to treat a patient in the DAYBREAK trial and look forward to enrolling more,” shares Dr. Coors. “Research has always been a core value of our practice as we strive to save sight and continually improve the care available to our patients.”
Studying Intravitreal Tarcocimab Tedromer for Diabetic Retinopathy
Dr. Coors also serves as a Principal Investigator for the Phase III GLOW2 study, which is evaluating intravitreal tarcocimab tedromer for diabetic retinopathy (NPDR).
For more information about participation in the DAYBREAK study at Texas Retina, click HERE to contact study coordinators Tara Keesling (Plano), Michelle Curry (Arlington) and Lori Mullen (Fort Worth).
Physicians can click HERE to directly refer a patient for this trial.
To learn more about all the clinical trials currently available at Texas Retina, click HERE.