Vabysmo Shows Significant Vision Improvement for Diabetic Macular Edema in Underrepresented Patients

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One year of treatment with Vabysmo (faricimab-svoa) for diabetic macular edema (DME) produced significantly improved vision among underrepresented racial and ethnic groups with no new safety concerns reported, according to data from the Phase IV ELEVATUM trial (NCT05224102).^1,2 These data, presented at the American Academy of Ophthalmology 2024 Annual Meeting, were similar to data reported in Phase III trials evaluating Vabysmo for DME, which supports the drug’s efficacy across diverse patient populations, according to investigators.

“Vabysmo has been shown to be an effective first-line treatment for diabetic macular edema, and for the first time, we now have data demonstrating its ability to improve vision in Black, African American, Hispanic, and Latino patients who are disproportionately impacted by this condition,” trial investigator Jeremiah Brown, MD, of Retina Consultants of Texas, said in a press release. “As a clinician who serves patients from these communities, I felt it was important to take part in this groundbreaking study and hope the findings will inform and improve the care we provide to our patients in the clinic daily.”¹

Vabysmo was the first bispecific antibody approved by the FDA to treat ocular conditions. The drug inhibits a pair of disease pathways involved in multiple vision-threatening retinal conditions by neutralizing angipoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).³ In January 2022, Vabysmo became the first and only FDA-approved bispecific eye medicine for diabetic macular edema and wet age-related macular degeneration.3 In July 2024, the FDA approved Vabysmo 6.0 mg as a single-dose prefilled syringe to treat patients with DME, wet age-related macular degeneration (AMD), and macular edema following retinal vein occlusion.⁴

The multicenter, open-label, single-arm ELEVATUM trial analyzed Vabysmo in the treatment of DME in 124 patients who are historically underrepresented in clinical trials. This included 45% who self-identified as Hispanic or Latino and 48% who self-identified as Black or African American. Patients enrolled in the trial were not previously treated with an anti‑vascular endothelial growth factor prior to study initiation. Patients were administered Vabysmo every four weeks up to week 20, followed by treatment every eight weeks up to week 52.

The trial was conducted at sites serving a high proportion of historically underrepresented populations in urban, rural, and community-based locations, according to the investigators. Eligibility criteria included having a hemoglobin A1c (HbA1c) level up to 12%. Historically, the threshold for DME trials generally requires an HbA1c level of 10%, which is commonly lower than levels seen in Black, African American, Hispanic and Latino populations compared with Caucasians, according to the investigators. They noted that a lower HbA1c threshold may exclude many patients from various ethnic and racial groups.

The trial’s primary endpoint is change from baseline in best corrected visual acuity after 56 weeks, with secondary endpoints that include safety and change in central subfield thickness from baseline over time.

After one year of treatment with Vabysmo administered every eight weeks, trial participants could read an average of an additional 12.3 letters, which equals approximately two-and-a-half lines on an eye chart. These findings were similar across major racial and ethnic groups in the trial, according to the investigators.

Hispanic and Latino individuals in the trial, who had the most severe disease at initiation, showed an average vision gain of 14.1 letters from baseline at one year, which equals approximately three lines on an eye chart. African American and Black patients in the trial experienced an average improvement of 11.3 letters from baseline at one year. In terms of safety, Vabysmo was well tolerated and no new safety signals were reported.

“Though certain ethnic and racial groups are disproportionately affected by DME, they lag far behind in clinical trial representation,” Gregory A. Rippon, MD, MS, vice president, US Medical Affairs, Genentech, said in the release. “We conducted the ELEVATUM study to specifically address this issue and understand how underrepresented patient populations respond to treatment with Vabysmo to help deliver better, more equitable care, and change how clinical trials are designed in the future.”¹

References

1. Genentech’s Vabysmo Improved Vision in Underrepresented Populations With Diabetic Macular Edema (DME) in a First-Of-Its-Kind Study. News release. Genentech. October 18, 2024. Accessed October 22, 2024. https://www.gene.com/media/press-releases/15041/2024-10-18/genentechs-vabysmo-improved-vision-in-un

2. A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema (ELEVATUM). ClinicalTrials.gov. Updated September 19, 2024. Accessed October 22, 2024. https://www.clinicaltrials.gov/study/NCT05224102

3. FDA approves Roche’s Vabysmo, the first bispecific antibody for the eye, to treat two leading causes of vision loss. News release. Roche. January 31, 2022. Accessed October 22, 2024. https://www.gene.com/media/news-features/fda-approves-genentech-s-bispecific-antibody-for-two-leading-causes-of-vision-loss

4. FDA Approves Genentech’s Vabysmo Prefilled Syringe (PFS) for Three Leading Causes of Vision Loss. Genentech. July 4, 2024. Accessed October 22, 2024. https://www.gene.com/media/press-releases/15030/2024-07-04/fda-approves-genentechs-vabysmo-prefille