Positive phase 2 study results reported for DME treatment
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Participants with diabetic macular edema treated with a senolytic Bcl-xL inhibitor in the phase 2 BEHOLD study experienced visual acuity improvement after 18 weeks, according to a press release from Unity Biotechnology.
The study enrolled 65 participants who were actively treated with anti-VEGF therapy and had a visual acuity deficit and residual retinal fluid.
After a single injection of UBX1325, participants experienced a mean improvement in best corrected visual acuity of 6.1 letters from baseline at 18 weeks compared with 1.1 letters in participants treated with sham (P = .0368). In addition, treated participants had a mean change in central subfield thickness of +3.2 µm from baseline at 18 weeks while those who received sham had a mean change of +53.5 µm; the difference was not statistically significant.
“The 12- and 18-week results indicate that a single injection of UBX1325 resulted in significantly greater letter gains and stabilization of retinal structure than the sham treatment, but also likely altered the disease trajectory of these patients who had been on anti-VEGF treatment,” Jamie Dananberg, MD, chief medical officer of Unity, said in the release. “We are greatly encouraged by these findings and look forward to our upcoming 24-week BEHOLD (DME) and 16-week ENVISION (wet AMD) study readouts in the months ahead.”
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