Mississauga– Bayer Inc. is pleased to announce that Health Canada has granted marketing authorization for EYLEA® HD (aflibercept injection 8mg/0.07mL), a new pre-filled syringe with integrated OcuClick™ dosing system. This new system will provide ophthalmologists with an efficient and simple way to deliver the 8 mg/0.07 mL of EYLEA® HD for the treatment of neovascular (wet) age-related macular degeneration (AMD) and the treatment of diabetic macular edema (DME).
“This approval highlights our commitment towards being patient-centric,” said Shurjeel Choudhri, Senior Vice President and Head, Medical & Scientific Affairs, Bayer Inc. “OcuClick™ dosing system offers healthcare professionals accuracy, ease of use, and control in the delivery of EYLEA® HD. This new ophthalmic syringe with the EYLEA® HD solution exemplifies our dedication to advancing patient care through innovation.”
The Canadian authorization 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. Serious adverse reactions related to the injection procedure, including intraocular pressure increased, have occurred in less than 1 in 4,300 intravitreal injections in the wet AMD study and in less than 1 in 1,500 injections in the DME study, in patients with up to 60 weeks of exposure to EYLEA® HD.
EYLEA® HD is jointly developed by Bayer and Regeneron Pharmaceuticals, Inc. Bayer has licensed the exclusive marketing rights outside the United States.
About EYLEA® HD and VEGF
EYLEA® HD has been approved to date in more than 50 countries for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME). Further regulatory applications for EYLEA® HD in additional countries are ongoing.
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs. It is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema.
EYLEA® HD (aflibercept injection) is a recombinant fusion protein consisting of portions of human VEGF receptor 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Aflibercept acts as a soluble decoy receptor that binds VEGF-A and Placental Growth Factor (PlGF) with higher affinity than their natural receptors, and thereby can inhibit the binding and activation of the cognate VEGF receptors.
About wet AMD and DME
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 and 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. 1
An estimated 200 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040.2 Approximately 2.5 million Canadians have AMD with nearly 180,000 experiencing vision loss.3 Diabetic retinopathy (DR) is the most common form of vision loss associated with diabetes. Affecting approximately 1 million Canadians, it is the leading cause of blindness among working-age adults. DR may advance into diabetic macular edema (DME), where damaged blood vessels leak into the macula, the central area of the retina, resulting in blurred vision and dark or distorted images. 4
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of healthcare 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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.ca.
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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 of the company and the estimates given 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.
[1]https://www.fightingblindness.ca/eyehealth/eye-diseases/age-related-macular-degeneration/
[2]https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2825172#:~:text=Projections%20indicate%20that%20the%20number%20of%20individuals,AMD%20are%20increasing%20age%2C%20smoking%2C%20and%20diet.
[3]https://iovs.arvojournals.org/article.aspx?articleid=2781783
[4]https://www.fightingblindness.ca/eyehealth/eye-diseases/diabetic-retinopathy/