An Investigational New Drug (IND) application is a crucial part of the drug development process. INDs are requests submitted to the U.S. Food and Drug Administration (FDA) that authorize the administration of an investigational drug or biologic to humans. Through this critical regulatory step, drug developers can shift from preclinical to clinical studies, beginning the process of garnering both safety and efficacy data. In early May 2024, Healio reported that the FDA accepted an IND for EB-105, a trispecific antibody in development for diabetic macular edema (DME).
What is Diabetic Macular Edema?
Macular edema is a condition where blood vessels leak blood or fluid into a part of the retina called the macula, leading to swelling and blurry vision. Diabetic retinopathy, a complication of diabetes, causes this to occur, leading to diabetic macular edema. Up to 10% of people with diabetes may develop this condition. This is especially pressing as biotechnology company Genentech shares that 34.2 million people in the United States alone have diabetes. Diabetes is now one of the leading causes of vision loss and new blindness in the country.
In diabetic macular edema, consistently high blood sugar damages small blood vessels in the eye. This condition can occur at any stage of diabetic retinopathy, reports Prevent Blindness, though it often manifests in later stages of disease progression. DME can manifest as:
- Blurred or double vision
- Dark spots (scotomas) in your field of vision
- Straight lines appearing bent or curved
- Difficulty seeing colors
- “Floaters” in your vision
- Difficulty seeing when there is a glare or bright lights
Current treatment options include anti-VEGF medications such as Eylea, Avastin, and Lucentis; laser photocoagulation; and a vitrectomy.
The Basics: EB-105
Eluminex Biosciences describes EB-105 as a trispecific antibody that:
contains functional units for inhibition of multiple clinically validated factors that contribute to vascular leakage, angiogenesis, and retinal inflammation.
The company shares that the therapy targets areas like interleukin-6 (IL-6) receptors (which have been linked to inflammation) and vascular endothelial growth factor A (VEGF-A), which plays a role in vascular permeability. Eluminex Biosciences believes that EB-105 could overcome the swelling and fluid retention (edema) that characterizes DME even while using treatments like Eylea (aflibercept).
