Unity's eye disease med passes extended phase 2 test, with Eylea battle on the horizon

A little more than a year ago, Unity Biotechnology’s future was uncertain after half the workforce was laid off amid a corporate shift toward ophthalmology.

But the recalibration appears to be paying off, with Unity’s treatment for diabetic macular edema (DME) nailing the primary endpoints at the 48-week mark of a phase 2 trial, according to an announcement Monday. Unity previously reported that the treatment—UBX1325—improved patients’ vision at the 24-week mark post-administration. 

The company reports that one injection of UBX1325 had a statistically significant improvement in vision throughout the duration of the trial compared to placebo as measured by the early treatment of diabetic retinopathy study letter score. Patients treated with UBX1325 had a 5.6 letter improvement compared to placebo. The drug was also found to reduce deterioration in retinal structure compared to placebo. 

More than half of treated patients went through the whole trial without requiring anti-VEGF rescue treatment, compared to 22% of participants on placebo. The company reports that UBX1325 was safe and tolerable. 

The data have infused Unity with so much confidence that it’s gearing up for a head-to-head matchup against Regeneron’s Eylea, with a phase 2 comparison trial slated for the second half of the year. Regeneron’s multibillion-dollar blockbuster was approved to treat diabetic retinopathy in patients with DME back in 2015. 

Unity laid off half of its staff in February 2022 as part of a broader pivot toward ophthalmology and UBX1325, which followed cuts to 30% of the staff in 2020. Now, the company seems to have a lead asset worth rallying around. 

Unity has already taken the fight to Eylea, with a phase 2 head-to-head trial ongoing in patients with age-related macular degeneration. An update to the clinical trial record last week indicates that recruitment has wrapped up in the trial, with an anticipated completion date in August. Unity reports that 51 patients were enrolled in the trial.