Genentech's Vabysmo (faricimab-svoa) has shown positive topline results in the phase 3 ELEVATUM study, demonstrating significant vision improvement in underrepresented racial and ethnic groups with diabetic macular edema (DME). The data, presented at the American Academy of Ophthalmology 2024 Annual Meeting, highlight the drug's potential to address disparities in DME treatment outcomes.
The ELEVATUM trial (NCT05224102) specifically investigated Vabysmo's efficacy in treatment-naïve DME patients from racial and ethnic groups often underrepresented in clinical trials. These groups included Black/African American, Hispanic/Latino American, Native American, Alaska Native, Native Hawaiian, and Pacific Islander individuals, as well as a cohort of Asian Indian patients enrolled in India.
Key Findings from ELEVATUM
After one year of treatment, patients in the study could read an average of 12.3 additional letters on eye charts, equivalent to 2.5 lines. Notably, the improvements were consistent across different racial and ethnic groups. Hispanic and Latino individuals gained an average of 14.1 letters, while African American and Black individuals gained an average of 11.3 letters.
"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," said Jeremiah Brown, MD, of Retina Consultants of Texas.
Trial Design and Patient Population
The ELEVATUM study enrolled individuals aged 18 years and older with either type 1 or type 2 diabetes and a hemoglobin A1C of 10% or less (with a 20% allowance up to 12%). Participants were treatment-naïve for intravitreal treatments in the study eye, had DME, and a best corrected visual acuity (BCVA) letter score of 73 to 20 letters at baseline.
In the main study, patients received intravitreal injections of faricimab-svoa 6 mg every 4 weeks up to week 20, followed by 6 mg injections every 8 weeks up to week 52. A long-term extension phase involved 6 mg injections according to a personalized treatment interval dosing algorithm, ranging from every 4 weeks to every 24 weeks.
Safety and Tolerability
The study reported that Vabysmo was well-tolerated, with no new safety events identified. The safety profile was consistent with those observed in the phase 3 YOSEMITE (NCT03622580) and RHINE (NCT03622593) studies.
The primary outcome for the long-term extension phase includes monitoring the incidence and severity of ocular and non-ocular adverse events (AEs) from day 1 until the end of the extension (up to 100 weeks).
Implications for DME Treatment
Diabetic macular edema is a common complication of diabetes and a leading cause of vision loss. The ELEVATUM trial provides crucial evidence supporting Vabysmo's effectiveness in diverse patient populations, addressing a significant unmet need in DME treatment. These findings could lead to improved care and outcomes for patients from underrepresented communities who are disproportionately affected by DME.
