Roche announced that faricimab met its primary endpoint in two clinical trials, BALATON and COMINO, showing non-inferior visual acuity gains compared to aflibercept.
Roche today announced positive new data from two global phase III studies, BALATON and COMINO, evaluating faricimab (Vabysmo) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO) at 24 weeks.1,2
According to a news release from Roche, the studies showed that treatment with faricimab resulted in early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains compared to treatment with aflibercept.
Roche also noted that faricimab also showed rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness. The safety profile of faricimab was consistent with previous trials.
Results will be presented virtually on Saturday at Angiogenesis, Exudation and Degeneration 2023, organizd by the 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,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development said in a news release. “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.”
Data from the BALATON and COMINO studies will be submitted to health authorities around the world, including the FDA and European Medicines Agency, for approval for the treatment of macular edema due to RVO. If approved, this would be the third indication for faricimab, which is currently approved in more than 50 countries to treat nAMD and DME.
“Retinal vein occlusion can cause fluid to become trapped within and under the retina, leading to rapid and severe vision loss if left untreated,” said Ramin Tadayoni, MD, PhD, president-elect of EURETINA, who is presenting the data at Angiogenesis. “These promising results show that Vabysmo effectively reduces fluid in the retina and improves vision in patients with retinal vein occlusion.”
Moreover, the Roche news release added that faricimab’s efficacy and safety in nAMD and DME have been demonstrated by two-year data from four large, global studies involving more than 3,000 participants.3-6
According to the news release, In the BALATON and COMINO studies, patients were randomly assigned 1:1 to receive six monthly injections of either faricimab (6.0 mg) or aflibercept (2.0 mg) for 20 weeks, with the primary endpoint measured at week 24.
The company noted that both studies met their primary endpoint, with faricimab 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 faricimab arm and +17.5 letters in the aflibercept arm at 24 weeks. In COMINO, vision gains were +16.9 letters in the faricimab 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.7 A secondary endpoint showed that faricimab 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 μm in the Vabysmo arm and -304.4 μm in the aflibercept arm. In COMINO, CST reductions were -461.6 μm in the Vabysmo arm and -448.8 μm 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, faricimab’s safety profile was consistent with previous trials. The most common adverse reaction was conjunctival haemorrhage (3%). Safety results were consistent across study arms.
The news release noted that the studies are ongoing, and data from weeks 24 to 72 will assess the potential of faricimab to extend dosing intervals up to every four months.
1 Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to branch retinal vein occlusion (BALATON) [Internet; cited January 2023]. Available from: https://clinicaltrials.gov/ct2/show/NCT04740905.
2 Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to central retinal or hemiretinal vein occlusion (COMINO) [Internet; cited January 2023]. Available from: https://clinicaltrials.gov/ct2/show/NCT04740931.
3 Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (nAMD) (TENAYA and LUCERNE): two randomised, double-masked, phase III, non-inferiority trials. The Lancet. 2022; 399:729-740.
4 Wykoff C, et al. Efficacy, durability and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular edema (DME) (YOSEMITE and RHINE): two randomised, double-masked, phase III trials. The Lancet. 2022; 399:741-755.
5 Wells JA, et al. Faricimab in DME: two-year results from the phase III YOSEMITE and RHINE trials. Presented at: Angiogenesis, Exudation and Degeneration 2022; 11-12 February 2022; virtual.
6 Khanani A, et al. Faricimab in nAMD: year 2 efficacy, safety and durability results from the phase III TENAYA and LUCERNE trials. Presented at: 2022 American Society of Retina Specialists Annual Scientific Meeting; 13-16 July 2022; New York City, NY, USA.
7 National Eye Institute. Macular Edema [Internet; cited January 2023]. Available from: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-edema#:~:text=What%20is%20macular%20edema%3F,swelling%20and%20prevent%20vision%20loss