Therapeutic in development to take on diabetic macular edema
Key Takeaways
- Current treatments for diabetic macular edema (DME) require frequent injections and are not fully effective for many patients.
- Allgenesis is developing an alternative to standard treatments that showed promise in treating DME in a first-in-human clinical trial.
With 37 million people in the United States impacted by diabetes, and cases of diabetic macular edema (DME) on the rise, pipelines are primed for the development of new treatment options to combat the disease. DME results from buildup of fluid in the macula from leaky blood vessel walls. (The macula is a small but important area in the center of the retina that allows you to clearly see details of objects in front of you; damage to the macula causes symptoms like blurry vision and dark spots.) Left untreated, the disease can progress to total vision loss, highlighting the need for a prompt diagnosis and early intervention. DME is currently treated with anti-VEGF medications, but these require frequent eye injections and are not sufficiently effective for a large number of patients.
David Boyer, MD, Adjunct Clinical Professor of Ophthalmology at the University of Southern California, Keck School of Medicine, participated in the first-in-human study of AG-73305 (Allgenesis), a novel protein drug for the treatment of DME, with the initial focus on safety and efficacy. Boyer explained that “this drug was designed to achieve two things: A different mode of action in addition to anti-VEGF to try to improve the overall diabetic macular edema, and to extend treatment intervals so that patients don’t have to come in as frequently.”
In the clinical trial, Boyer noted the goal was to evaluate the safety, tolerability, duration of effect, and the drug profile of ascending doses of AG-73305 administered by eye injection in patients diagnosed with DME. The researchers also set out to evaluate both anatomical and visual outcomes.
During the trial, patients saw an immediate improvement, and the effects of the drug lasted longer than standard anti-VEGF medication. The next step is to continue along the clinical trial path, with the goal of one day providing a new treatment option for patients diagnosed with DME. Allgenesis officials told Ophthalmology Times they will continue seeking funding to continue the clinical trials. Once funding is secured to support its work, the company will produce, develop, and refine the product as it enters Phase 2b, which could start in 2025 or early 2026.
Edited by Miriam Kaplan, PhD
Source:
David Hutton, Ophthalmology Times, July 25, 2024; see source article