Health Canada approves faricimab injection for the treatment of wet AMD, DME

Roche Canada announced today that Health Canada authorized faricimab injection (Vabysmo) for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME),⁶ two of the leading causes of vision loss among Canadians.¹

Faricimab is the first treatment for wet AMD and DME in Canada that acts by targeting both VEGF-A and Ang-2, two key drivers of vascular instability that have been associated with vision-threatening retinal conditions.^2,3,4,5 This unique dual MoA is made possible by Roche's antibody engineering expertise.

"Faricimab, a new drug to treat wet AMD and DME, shows from the pivotal clinical trials an increase in treatment durability that may lessen the burden for patients and doctors while best maintaining our patient's vision," said David T. Wong, MD, ophthalmologist-in-chief and associate professor at Unity Health at St. Michael's Hospital.

In wet AMD and DME, faricimab may improve vision outcomes with fewer injections into the eye⁷ – potentially helping to reduce the treatment burden for patients, caregivers, and their families.⁸

"The approval of VABYSMO is welcomed by Canadians living with wet AMD and DME," said Doug Earle, president and CEO, Fighting Blindness Canada. "It's critical to have treatment options and strategies that can reduce the burden of frequent injections for those living with a blinding eye disease. Frequent appointments can be challenging for both patients and caregivers, particularly for those in rural areas or with limited mobility – and access to treatment is critical to addressing vision loss."

According to Roche, positive results from four Phase III studies support the potential of faricimab to offer an effective new treatment option for people living with DME and wet AMD, while maintaining a similar safety profile to the current standard of care.⁹

In the studies conducted, about half of eligible individuals on faricimab were able to go 4 months between treatments within the first year, and up to three-quarters could go 3 months or longer in the TENAYA and LUCERNE nAMD studies and the YOSEMITE and RHINE DME studies.

Currently, the standard of care for these conditions requires eye injections as often as once every month.

For retina specialists, the approval is welcome news and offers a new treatment option for patients.

The FDA in January gave its approval to faricimab for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

About the Health Canada Approval

In wet AMD, the Phase III TENAYA and LUCERNE studies show VABYSMO – when given at intervals of up to four months based on assessments of pre-specified visual and anatomic criteria at Weeks 20 and 24 as well as treating physician clinical assessment – consistently offers visual acuity gains non-inferior to the current standard of care, aflibercept. The primary endpoint of these studies is the average change in best-corrected visual acuity (BCVA) score from baseline. The average vision gains from baseline at one year in the VABYSMO arms were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the aflibercept arms.¹⁰

In DME, the Phase III YOSEMITE and RHINE studies showed that VABYSMO met its primary endpoint with dosing intervals of up to every four months consistently shown to offer visual acuity gains that were non-inferior to aflibercept given every two months. According to these findings, the average vision gains from baseline at one year in YOSEMITE were +11.6 and +10.7 eye chart letters in the VABYSMO treat-and-extend and two-month arms, respectively (with +10.9 letters in the aflibercept arm); in RHINE, the average gains from baseline at one year were +10.8 and +11.8 letters in the VABYSMO treat-and-extend and two-month arms, respectively (with +10.3 letters in the aflibercept arm).¹¹

References

1 CNIB Foundation. The Cost of Vision Loss Report – Blindness in Canada. Available at: https://cnib.ca/en/sight-loss-info/blindness/blindness-canada?region=on. Accessed on May 3, 2022.

2 VABYSMO Product Monograph, May 27, 2022.

3 BEOVU Product Monograph, February 17, 2022.

4 EYLEA Product Monograph, February 10, 2022.

5 LUCENTIS Product Monograph, December 21, 2021.

6 VABYSMO Product Monograph, May 27, 2022.

7 VABYSMO Product Monograph, May 27, 2022.

8 Review of Ophthalmology. "Easing the Anti-VEGF Treatment Burden". Available at: https://www.reviewofophthalmology.com/article/easing-the-antivegf-treatment-burden. Accessed on May 4, 2022.

9 VABYSMO Product Monograph, May 27, 2022.

10 VABYSMO Product Monograph, May 27, 2022.

11 VABYSMO Product Monograph, May 27, 2022.