Vabysmo is the first injectable bispecific antibody to treat wet age-related macular degeneration and diabetic macular edema. Some recent data suggests that the injections can be administered less often than first indicated with no loss of efficacy.
New two-year data show that Vabysmo (faricimab-svoa) maintains its effectiveness four months after injection in patients with wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). When approved by the FDA in January 2022, Vabysmo was given one to four months apart in the first year following four initial monthly doses.
The data, which were presented at the American Society of Retina Specialists Annual Scientific Meeting on July 14, 2022, indicate that more than 60% of Vabysmo patients could be treated every four months at two years.
Vabysmo, a first-in-class therapeutic, is a bispecific antibody that targets and targets two disease pathways that drive wet AMD and DME. It blocks two disease pathways: angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), both of which are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. It is the only injectable eye medicine with the option for treatments from one to four months apart in the first year following four initial monthly loading doses.
The first presentation at the July meeting discussed two phase 3 studies, TENAYA and LUCERNE, in patients with wet AMD. At two years, vision improvements were comparable across both treatment arms. In TENAYA, the average vision gain from baseline at two years was 3.7 eye chart letters in the Vabysmo arm and 3.3 letters in the aflibercept arm. In LUCERNE, the average vision gains from baseline at two years were 5.0 letters in the Vabysmo arm and 5.2 letters in the aflibercept arm.
Additionally, 59% of patients treated with Vabysmo in TENAYA and 67% in LUCERNE achieved four-month dosing at two years. This is an increase over one-year results, which showed 46% of Vabysmo patients in TENAYA and 45% in LUCERNE achieved four-month dosing. An additional 15% of Vabysmo patients in TENAYA and 14% in LUCERNE achieved three-month dosing at two years. Combined, more than 78% of Vabysmo patients were able to go three months or longer between treatments at the end of the second year.
No cases of retinal vasculitis or occlusive retinal vasculitis were reported.
“Overall, the two-year data from the phase 3 TENAYA and LUCERNE studies showed that Vabysmo has the ability to provide a safe treatment option for wet AMD patients that extends the time between treatments,” lead investigators Arshad M. Khanani, M.D., with the Sierra Eye Associates in Reno, Nevada, said. “Nearly 80% of people receiving Vabysmo could be treated every three months or longer at the end of the second year.
Khanani said extending the time between treatments is so important for our patients who may otherwise receive injections as often as every month. “As you can imagine, going to your doctor’s office that often can be burdensome not only for our patients, but their caregivers as well which often accompany their loved ones to these appointments given the age of this population,” he said. “That’s why as a retinal specialist, I am excited to have a new option in my clinic that is durable and effective in treating wet AMD that allows my patients to decrease their treatment burden while controlling their wet AMD.”
Longer term studies in patients with wet AMD continue. Specifically, AVONELLE-X, an extension study of TENAYA and LUCERNE, will evaluate four-data for the long-term safety and tolerability of Vabysmo in these patients.
The second presentation at the American Society of Retina Specialists meeting discussed two phase 3 studies, YOSEMITE and RHINE, in patients with age-relate macular degeneration. In these studies, patients who received Vabysmo had comparable one-year best-corrected visual acuity (BCVA) that were maintained through year year two. Vabysmo was well tolerated through study end, and no cases of retinal vasculitis or occlusive retinal vasculitis were reported.
The ongoing RHONE-X long-term extension study will generate four-year data in patients with macular degeneration.
Additionally, the COMINO and BALATON trials are also under way, evaluating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion. Genentech has also initiated the phase 4 Elevatum study of Vabysmo in underrepresented patient populations with diabetic macular edema.