Matthew Cunningham, MD: 1-Year ELEVATUM Data Target Disparities in DME

Promising results from the Phase 4 ELEVATUM trial revealed the effectiveness and safety of faricimab (Vabysmo) for patients with treatment-naive diabetic macular edema (DME) belonging to historically underrepresented groups in clinical research.

A first trial of its kind, ELEVATUM showed patients of African American, Black, Latino, and Hispanic race and ethnicity treated with faricimab experienced clinically significant improvements in visual acuity and retinal drying, without experiencing new safety concerns.

In an interview with HCPLive, investigator Matthew A. Cunningham, MD, the research director at Florida Retina Institute, described the goal of ELEVATUM, as these populations tend to experience a disproportionate amount of DME, but remain underrepresented in clinical trials.

“It’s always been a question mark as to why underrepresented minorities or populations as a whole have such low recruitment rates in our clinical trials,” Cunningham said. “Interestingly enough, [ELEVATUM] actually got to our number, 124 patients, one month before the expected time of enrollment.”

A key endpoint in ELEVATUM was the improvement in visual acuity. Hispanic patients who entered the trial with worse visual acuity, and a thicker macula, than African American patients experienced more significant visual gains and drying. In particular, the vision gains were 14 letters for the Hispanic population, compared with 11 letters for African American patients.

“As a whole, when we look at the total patients over the 52 weeks, that's a 12.3 letter gain over the entire study population,” Cunningham added. This is very important and very consistent with what we saw with YOSEMITE and RHINE.”

Another notable finding in ELEVATUM was a reduction in macular thickness—by 206 µm on average—indicating improved retinal health for this population. Approximately 32% of patients experienced a ≥2-step improvement in the Diabetic Retinopathy Severity Score (DRSS), another significant milestone in managing the progression of DME.

ELEVATUM also tackled a major challenge in retinal care, the burden of frequent injections. For the first 20 weeks, patients received faricimab every 4 weeks (Q4W), followed by an extension to every eight weeks (Q8W) until Week 52, remaining similar to the pivotal trials.

“Treatment burden is a major reason why patients with DME are lost to follow-up or don't come back,” Cunningham said. “If we have an agent that is giving them that durability, and we're seeing that clinical advantage in terms of visual gains and clinically significant macular drying, that's extremely attractive to retina specialists and patients alike.”

References

_{Treatment Response and Safety of Faricimab in Underrepresented Patients with DME: Year 1 Results from ELEVATUM in the US. Presented at the American Academy of Ophthalmology (AAO) 2024 Meeting. Chicago, Illinois. October 18-21, 2024.}