Phase III data show Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion (RVO)

The studies showed that treatment with Vabysmo resulted in early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains compared to treatment with aflibercept. Vabysmo also showed rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness. The safety profile of Vabysmo was consistent with previous trials. Results will be presented virtually on February 11 at Angiogenesis, Exudation, and Degeneration 2023, organized by Bascom Palmer Eye Institute in Florida.

“These encouraging results reinforce the potential of Vabysmo as a new treatment option for people experiencing vision loss associated with retinal vein occlusion,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “As these positive data continue to accrue, we believe Vabysmo may redefine the standard of care for multiple types of retinal conditions that can cause blindness.”

Wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME), and RVO together affect around three million people in the United States and are among the leading causes of vision loss. Data from the BALATON and COMINO studies will be submitted to health authorities around the world, including the FDA and EMA for approval for the treatment of macular edema due to RVO. If approved, this would be the third indication for Vabysmo, which is currently approved in more than 50 countries to treat wet AMD and DME.

Vabysmo’s efficacy and safety in wet AMD and DME have been demonstrated by two-year data from four large, global studies involving more than 3,000 participants. Vabysmo is the only injectable eye medicine approved for wet AMD and DME by the FDA with the option for treatments from one to four months apart in the first year following four initial monthly loading doses, based on evaluation of the patient’s anatomy and vision outcomes. It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Globally, more than 450,000 Vabysmo doses have been distributed for treatment of these conditions to date.

Study Results : In the BALATON and COMINO studies, patients were randomized 1:1 to receive six monthly injections of either Vabysmo (6.0 mg) or aflibercept (2.0 mg) for 20 weeks, with the primary endpoint measured at week 24. Both studies met their primary endpoint, with Vabysmo showing non-inferior visual acuity gains compared to aflibercept. The average vision gains from baseline were comparable between the two treatments in both studies. In BALATON, vision gains were +16.9 eye chart letters in the Vabysmo arm and +17.5 letters in the aflibercept arm at 24 weeks. In COMINO, vision gains were +16.9 letters in the Vabysmo arm and +17.3 letters in the aflibercept arm at 24 weeks. Additionally, the percentage of patients gaining 15 or more letters was comparable across treatment arms in both studies.

Fluid in the retina in the back of the eye, which may result from blood vessel leakage, can cause swelling and blurry vision. A secondary endpoint showed that Vabysmo achieved rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness (CST) . In both studies, reductions in CST were comparable across treatment arms. In BALATON, CST reductions were -311.4 um in the Vabysmo arm and -304.4 ?m in the aflibercept arm. In COMINO, CST reductions were -461.6 ?m in the Vabysmo arm and -448.8 um in the aflibercept arm. Additionally, both studies showed that more Vabysmo patients had an absence of blood vessel leakage in the retina compared to aflibercept patients as seen in a pre-specified exploratory endpoint. In BALATON, one-third of patients (34%) treated with Vabysmo had an absence of leakage compared to one-fifth (21%) of aflibercept patients. In COMINO, the rates were 44% for Vabysmo patients versus 30% for aflibercept patients.In both studies, Vabysmo’s safety profile was consistent with previous trials. The most common adverse reaction was conjunctival hemorrhage (3%). Safety results were consistent across study arms.

The studies are ongoing, and data from weeks 24 to 72 will assess the potential of Vabysmo to extend dosing intervals up to every four months