EYLEA® HD receives market authorization in Canada for the treatment of macular edema secondary to retinal vein occlusion
The most recent indication offers a treatment option for people experiencing macular edema caused by retinal vein occlusion (RVO), a condition that can lead to sudden vision changes or vision loss.
- Pharmaceuticals
● This new indication is supported by the QUASAR study, where EYLEA® HD provided non-inferior vision gains versus aflibercept 2 mg at week 36. Patients who completed treatment with EYLEA HD required fewer injections than aflibercept 2mg at week 64.1
● After three initial monthly doses, EYLEA® HD is dosed at 8-week intervals and further individualized up to a maximum of 16 weeks in 4-week increments, based on the healthcare professional's judgement of visual and anatomic outcomes.1
MISSISSAUGA, ON, October 28, 2026 - Bayer Inc. announced today that Health Canada has granted a Notice of Compliance for EYLEA® HD (aflibercept injection, 8 mg/0.07 mL) for the treatment of macular edema secondary to retinal vein occlusion (RVO).1
With this authorization, EYLEA® HD is now available for three indications: macular edema secondary to retinal vein occlusion, neovascular (wet) age-related macular degeneration, and diabetic macular edema.1
“For patients living with retinal vein occlusion, preserving vision while reducing the burden of frequent appointments and disruption to daily routines can make a meaningful difference in daily life. This expanded authorization reflects our continued commitment to advancing innovations that respond to both patients’ clinical needs and the realities of treatment,” says Viktoria Friedrich, President and CEO of Bayer Inc. and General Manager, Pharmaceutical Division.
Vision loss caused by RVO can make everyday activities, including reading and driving, more difficult.2 Anti-vascular endothelial growth factor (anti-VEGF) injections are a first-line treatment for RVO-associated macular edema.2
“The approval of EYLEA® HD for retinal vein occlusion represents a potential paradigm shift in how we manage this sight-threatening disease. What sets the QUASAR Phase III clinical program apart is its focus on early treatment interval extension, challenging the traditional approach of prolonged monthly injections. The ability to extend treatment intervals earlier while maintaining meaningful visual and anatomical outcomes has the potential to redefine treatment expectations and reduce the burden of care for patients living with RVO”, said Dr. Varun Chaudhary, Professor & Academic Head of Ophthalmology, McMaster University, Chief of Ophthalmology, St Joseph’s Healthcare Hamilton and Hamilton Health Sciences.
EYLEA® HD is jointly developed by Bayer and Regeneron Pharmaceuticals, Inc. Bayer has licensed the exclusive marketing rights outside the United States.
About the QUASAR Study
QUASAR was a Phase III, randomized, double-blind, active-controlled study in which 892 patients were treated and included in the efficacy analysis.1 EYLEA® HD, administered every eight weeks after three or five initial monthly injections, was non-inferior to aflibercept 2 mg administered every four weeks for the primary endpoint of change in best-corrected visual acuity at week 36.1
Among patients who completed week 64, the mean number of injections was 8.4 in the EYLEA® HD group receiving three initial monthly doses and 11.7 in the aflibercept 2 mg group.1 Mean vision gains from baseline at week 64 were 17.3 and 17.4 letters, respectively. Dosing intervals could be adjusted under the trial protocol.1 At week 64, 56.1% (151/269) of patients who completed treatment in the EYLEA® HD group receiving three initial monthly doses had completed a 16-week treatment interval.1
Serious adverse reactions related to the injection procedure have occurred in 0.3% of patients in the RVO study, in patients with up to 64 weeks of exposure to EYLEA® HD.1
About RVO
RVO can involve the main retinal vein (central RVO), a smaller branch (branch RVO), or venous drainage from approximately half of the retina (hemiretinal RVO).2 Macular edema and reduced blood supply to the retina can impair vision; abnormal new blood vessels can also lead to complications.2 Increasing age, hypertension and glaucoma are recognized risk factors.2 Canadian recommendations emphasize assessment and management of associated systemic risk factors alongside eye care.2
RVO can cause sudden vision loss and is estimated to affect approximately 28 million adults worldwide.2 Canadian epidemiologic data remain limited, as noted in a 2026 Canadian review.2 A 2012 study of Southwestern Ontario family-practice records from 2008–2009 identified 73 new RVO diagnoses among 47,166 people older than 40 years.3 In that study population, the estimated annual incidence of visual impairment caused by macular edema secondary to branch RVO was 0.056% (56 per 100,000), compared with 0.021% (21 per 100,000) for central RVO.3 These historical regional estimates should not be interpreted as a current national prevalence estimate or as the number of Canadians living with RVO.3
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.
Forward-looking statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance and the estimates provided here. These factors include those discussed in Bayer’s public reports, which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Contact for media inquiries:
Communications Department
Bayer Inc.
mediacanada@bayer.com
Find more information at www.bayer.ca
References
1. Bayer Inc. EYLEA® HD Canadian Product Monograph, 2026-10-26. https://bag-p-001.sitecorecontenthub.cloud/api/public/content/eylea-hd-pm-en-3a6db2cc6b0548318ae6051befcc658a?v=962a236d
2. Sivachandran N, et al. Optimal Treatment of Retinal Vein Occlusion: An Updated Canadian Review and Recommendations. Clin Ophthalmol. 2026;20:577821. https://pmc.ncbi.nlm.nih.gov/articles/PMC12988745/
3. Petrella RJ, et al. Incidence and Characteristics of Patients with Visual Impairment due to Macular Edema Secondary to Retinal Vein Occlusion in a Representative Canadian Cohort. J Ophthalmol. 2012;2012:723169. https://pmc.ncbi.nlm.nih.gov/articles/PMC3477564/