In a late April 2023 news release, biotechnology company UNITY Biotechnology, Inc. (“UNITY”) shared that the company had observed positive long-term follow-up data from the Phase 2 BEHOLD trial. Within the trial, researchers were evaluating UBX1325 as a potential treatment option for diabetic macular edema, or DME.
UBX1325 is an investigational Bcl-xL inhibitor. As UNITY explains, UBX1325 is:
intended to target senescent cells and selectively eliminate these cells in and around diseased vasculature in the eye, while leaving healthy blood vessels intact.
Outside of DME, UNITY is also developing UBX1325 as a potential solution for diabetic retinopathy and age-related macular degeneration (AMD).
65 participants with DME who used anti-VEGF therapies enrolled in the study. During the trial, participants received 10mcg UBX1325 for an initial 24-week period. 50 of the 65 participants joined the study’s extension and were treated for a total of 48 weeks. Participants had not responded well to anti-VEGF therapy; despite frequent injections, they still experienced a loss of visual acuity and issues with residual retinal fluid.
UBX1325 seemed to confer significant benefits for participants. First, just a singular treatment dose helped to maintain the stability of the retinal structure compared to participants who received a placebo. Next, UBX1325 was found to be safe and well-tolerated; it didn’t cause any issues associated with eye inflammation or vasculitis. Then, 53% of participants on UBX1325 required no additional anti-VEGF therapy during the treatment period, which is 31-percentage points higher than the placebo group. Finally, UBX1325 showed significant improvement in Best Corrected Visual Acuity, rising +6.2 ETDRS letters from where participants began.
UNITY soon hopes to begin more research comparing UBX1325 to the current standards-of-care.
What is Diabetic Macular Edema (DME)?
Diabetic macular edema is a condition in which the macula (the center part of the retina) becomes swollen and inflamed. This can cause vision issues and, without intervention, lead to complete blindness. DME happens as a consequence of another diabetes-related complication called diabetic retinopathy. Currently, an estimated 1 in every 14 people with diabetes will eventually develop DME. Symptoms of diabetic macular edema may include:
- “Floaters” in your field of vision
- Blurred or double vision
- Dark or empty areas in your vision
- Difficulty seeing colors
- Straight lines that appear wavy or curved when you look at them
- Fluctuating vision
- Worsening vision loss
Anti-VEGF therapy, steroids, and injectables such as VABYSMO, Iluvien, or Eyelea may be used for treatment.
