Data Show Vabysmo Effective, Safe in Treatment of Wet Age-Related Macular Degeneration

New 2-year data from the TENAYA and LUCERNE studies reinforce the long-term efficacy, safety, and durability of faricimab-svoa (Vabysmo) in wet or neovascular age-related macular degeneration (AMD), according to an announcement from Genentech, a member of the Roche Group.

Patients treated with faricimab-svoa received fewer and less frequent injections while experiencing comparable vision improvements compared to aflibercept, another treatment for AMD. The 2-year data were presented at the American Society of Retina Specialists Annual Scientific Meeting on July 14, 2022.

“These longer-term results reinforce confidence in Vabysmo and support its continued use in people with wet AMD,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a statement.

The TENAYA and LUCERNE studies are identical phase 3 studies evaluating the efficacy and safety of faricimab-svoa compared to aflibercept in 1329 people living with wet AMD. Participants were given faricimab-svoa at internals of 2, 3, or 4 months or aflibercept administered every 2 months.

Vision improvements were comparable between the two treatments at 2 years in both studies.

However, at 2 years, more than 60% of people receiving faricimab-svoa could be treated every 4 months compared to aflibercept given every 2 months, while achieving comparable vision gains, which represents an increase of more than 15 percentage points since the primary analysis at 1 year.

Researchers found that nearly 80% of people receiving faricimab-svoa could be treated every 3 months or longer.

Patients treated with faricimab-svoa received a median number of 10 injections over the 2 years. Given that patients treated with aflibercept receive a median of 15 injections over 2 years, this could potentially decrease the number of injections patients receive in treatment.

Researchers observed comparable reductions in central subfield thickness (CST) with faricimab-svoa given at intervals of up to 4 months compared with aflibercept given every 2 months.

No new safety signals were observed in this analysis. Faricimab-svoa continued to be well-tolerated with a favorable benefit-risk profile, according to the release.

Generally, these results suggest that faricimab-svoa may allow patients to improve their vision with fewer treatments.

“With the potential to require fewer injections over time, Vabysmo continues to represent an important step forward for people with vision-threatening retinal conditions, and these data exemplify our commitment to redefining standards of care and reducing treatment burden,” Garraway concluded.

According to the release, Vabysmo is the first bispecific antibody for the eye and the only injectable eye medicine approved by the FDA with the option for treatments from 1 to 4 months apart in the first year following 4 initial monthly loading doses, based on evaluation of the patient’s anatomy and vision outcomes.

A primary analysis conducted at 1 year in the TENAYA and LUCERNE studies formed the basis of recent wet AMD approvals for Vabysmo in the United States, Japan, the UK, and other countries. Vabysmo is also approved for diabetic macular edema in these countries.

Reference

New two-year data confirm Genentech’s Vabysmo improves vision with fewer treatments for people with wet-age-related macular degeneration [press release]. South San Francisco, CA: Genentech Inc; July 14, 2022. https://www.gene.com/media/press-releases/14960/2022-07-14/new-two-year-data-confirm-genentechs-vab. Accessed July 15, 2022.