Mississauga, February 16, 2024 – Health Canada has approved EYLEA HD (aflibercept injection) for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).
EYLEA HD is approved for administration at treatment intervals of up to every four months, following three initial monthly doses, based on physician’s judgement of visual and anatomic outcomes.
“By reducing patient burden through the potential of fewer intravitreal injections, EYLEA HD represents an advancement in the treatment of wet AMD and DME” said Dr. Shurjeel Choudhri, Senior Vice President and Head of Medical and Scientific Affairs for Bayer Canada.
The Canadian approval of EYLEA HD is based on results from the PULSAR clinical trial in wet AMD and the PHOTON clinical trial in DME. The studies compared EYLEA HD administered at 12- or 16-week dosing intervals to EYLEA administered at a fixed 8-week treatment interval. Both studies met their primary endpoint of non-inferior best corrected visual acuity (BCVA) changes with EYLEA HD compared to EYLEA at week 48. At this time point, in PULSAR 77% of wet AMD patients were maintained on a 16-week dosing regimen, and in PHOTON 89% of DME patients were maintained on a 16-week dosing regimen. The safety of Eylea HD in PHOTON and PULSAR was similar to the comparator, EYLEA. In PULSAR, the most frequently observed adverse reactions in at least 2% of patients treated with Eylea HD were cataract (4.6%), intraocular pressure increased (3.1%), vitreous floaters (2.7%), vitreous detachment (2.5%), and conjunctival hemorrhage (2.1%). In PHOTON, the most frequently observed adverse reactions in at least 2% of patients treated with Eylea HD were vitreous floaters (4.9%), conjunctival hemorrhage (4.3%), vitreous detachment (2.9%), punctate keratitis (2.2%), and eye pain (2.0%).
EYLEA HD (aflibercept injection) is jointly developed by Bayer and Regeneron.
About PULSAR and PHOTON
PULSAR and PHOTON are randomized, double-masked, active-controlled pivotal trials. Both trials were conducted in multiple centers globally, including Canada, with similar designs and endpoints. The Phase III PULSAR trial in wet AMD and Phase II/III PHOTON trial in DME evaluated the efficacy and safety of EYLEA HD with 12- and 16-week dosing regimens versus EYLEA dosed every 8 weeks, following initial monthly doses, with the primary endpoint of non-inferiority in terms of BCVA at week 48. Patients in both clinical trials were randomized at baseline to the three different arms. Across both studies, 1,164 patients were treated with EYLEA HD. All patients in the EYLEA HD arms were continuously evaluated under stringent, clinically relevant, patient focused dose regimen modification (DRM) criteria starting from week 16 throughout the study. In the first year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened down to an every 8-week interval if DRM criteria for disease progression were observed. Patients in all EYLEA groups maintained a fixed 8-week dosing regimen throughout their participation in the trials. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON.
About wet AMD and DME
Neovascular (wet) age-related macular degeneration (wet AMD) is an eye disease that progresses rapidly and if left untreated can lead to vision loss in a few months. Wet AMD is one of the leading causes of irreversible blindness and vision impairment around the world. Wet AMD may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. 196 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040. Approximately 10-15% of people with AMD will develop the advanced form wet AMD.
Diabetic macular edema (DME) is a common complication in eyes of people living with diabetes. DME occurs when high levels of blood sugar lead to damaged blood vessels in the eye that leak fluid into the macula. This can lead to vision loss and, in some cases, blindness. Globally, 146 million people are currently living with diabetic retinopathy (DR), which can develop into a more serious condition which is diabetic macular edema. DME is affecting around 21 million people globally.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its 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 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.ca.
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