Bayer Receives Health Canada Approval for Eylea® for Two Additional Indications

Treatment of Visual Impairment due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO) and Diabetic Macular Edema (DME) are the Second and Third Indications for Eylea^® in Canada

MISSISSAUGA, ON, Dec. 1, 2014 /CNW/ - Bayer Inc. announced today that it has received approval from Health Canada for Eylea^® (aflibercept, solution for intravitreal injection) for the treatment of diabetic macular edema (DME). This new indication comes just six weeks following the October 16^th approval of Eylea^® for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). These approvals are the second and third indications for Eylea^®, which was first approved in Canada in November 2013 for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD).

"As an organization serving individuals for over 90 years who are blind or partially sighted, we know first-hand how sight-threatening conditions, such as CRVO and DME, can impact an individual's everyday life. The additional approvals for Eylea^® in Canada mean that patients with CRVO and DME will have more treatment options available to help maintain their sight and help them carry out their daily activities," said Dr. Keith Gordon, CNIB, Vice President Research. "This new treatment option may reduce vision loss due to DME and CRVO, allowing individuals to better maintain their independence."

CRVO and DME are significant causes of vision loss in Canada. CRVO affects approximately one person per 1000 at any one time, and is associated with increasing age, high blood pressure, diabetes, glaucoma and various disorders of the blood.^[i] It is estimated that vision impairment resulting from DME affects approximately 2.5 per cent of the nearly 2.4 million Canadians with diabetes, or approximately 60,000 Canadians, making it a major cause of adult onset vision loss.^[ii]

Diabetic Macular Edema (DME) Approval^[iii]
The Health Canada approval of Eylea^® for the treatment of DME is based on the results of two Phase III clinical studies (VIVID^DME and VISTA^DME). In both studies, Eylea^® dosed 2 milligrams monthly (2Q4) and Eylea^® dosed 2 milligrams every two months (after 5 initial monthly injections) (2Q8), achieved the primary endpoint of significantly greater improvements in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks. Further, in the VISTA^DME study, patients gained a mean +12.5 (2Q4) and +10.7 (2Q8) letter improvement from baseline and approximately a third of patients gained three lines of vision or more.

The most common adverse reactions were conjunctival hemorrhage, eye pain, cataract and vitreous floaters.

The recommended dose for Eylea^®  for the treatment of DME in Canada is 2 mg aflibercept (equivalent to 50 microliters solution for injection) administered by intravitreal injection monthly (once every 4 weeks) for the first 5 consecutive doses, followed by one injection every 2 months (8 weeks).

"The results of two Phase III studies were very positive. Significantly more patients with visual impairment due to diabetic macular edema experience a two- and three-line improvement in visual acuity with Eylea^®," said Dr. Michael Kapusta, Ophthalmologist-In-Chief, Jewish General Hospital, and Director of Retina, McGill University, Montreal. "The decision to approve Eylea will offer retina specialists and their patients an excellent option in the management of DME."

Macular Edema Secondary to CRVO Approvalⁱⁱⁱ
The Health Canada approval of Eylea^® for the treatment of visual impairment due to macular edema secondary to CRVO is based on the results of two Phase III clinical studies (COPERNICUS and GALILEO). In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters in Best Corrected Visual Acuity (BCVA) at Week 24 compared to baseline. Superiority of treatment with Eylea^® versus treatment with sham injection was shown for the primary endpoint at 24 weeks in both studies. Rapid improvements in visual acuity were observed with Eylea^® treatment as early as 4 weeks after the first Eylea^® injection. 

The most common adverse reactions were conjunctival haemorrhage, intraocular pressure increased, eye pain, vitreous detachment and vitreous floaters.

The recommended dose for Eylea^® for the treatment of macular edema secondary to CRVO is 2 mg Eylea^® (aflibercept, solution for intravitreal injection) (0.05 mL or 50 microliters) administered by intravitreal injection once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy.

About VEGF and Eylea^® (aflibercept, solution for intravitreal injection)
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^®, also known as VEGF Trap-Eye, is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Eylea^® acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of their cognate VEGF receptors.

Eylea^® has been approved in more than 80 countries for use in wet AMD and more than 60 countries for the treatment of macular edema following CRVO. Eylea® is also approved for the treatment of DME in over 30 countries.

About Diabetic Macular Edema (DME)
Diabetic macular edema (DME) and diabetic retinopathy (DR) are common microvascular complications in people with diabetes. Diabetic retinopathy is a disease affecting the blood vessels of the retina. DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness.

Visual impairment due to DME is estimated to affect around 3 per cent of people with diabetes around the world and is therefore the most frequent cause of blindness in young and mid-aged adults in most developed countries.^[iv] As the incidence of diabetes has been steadily climbing, it is projected that the number of people impacted by DME will also grow.

About Central Retinal Vein Occlusion (CRVO)
CRVO is caused by obstruction of the central retinal vein that leads to an accumulation of deoxygenated blood and fluid in the retina. Macular edema secondary to CRVO causes retinal damage and loss of vision. Release of vascular endothelial growth factor (VEGF) contributes to increased vascular permeability in the eye and macular edema. It has been shown that anti-VEGF treatment helps decrease vascular permeability and edema in the retina in patients with CRVO.

About Wet AMD
AMD is a progressive eye disease that affects a person's central vision and is a leading cause of vision loss in Canadians over age 50. There are two forms of AMD – wet and dry. Wet AMD is the most severe form of the disease, and can result in a loss of central vision within weeks or months. Living with AMD can be extremely difficult – patients may no longer be able to read, drive or see the faces of family and friends. Without treatment, AMD can lead to blindness.^{[v],[vi],[vii]}

About CNIB
CNIB is a registered charity, passionately providing community-based support, knowledge and a national voice to ensure Canadians who are blind or partially sighted have the confidence, skills and opportunities to fully participate in life. For more information, visit www.cnib.ca. 

About Bayer in Canada
Bayer Inc. is a Canadian subsidiary of Bayer AG and the corporate headquarters for the Canadian operations. Founded in 1863, Bayer AG is an international research-based group with core businesses in healthcare, crop science and innovative materials committed to creating a better life for all through science.

In Canada, Bayer operates its healthcare business – Pharmaceuticals, Consumer Care, Diabetes Care, Animal Health and Radiology & Interventional – from its headquarters in Mississauga, ON, and Bayer CropScience Inc. operates out of its head office in Calgary, AB. Together with its material science business, Bayer improves the quality of life for Canadians through products that fight disease, protect crops and animals, and provide high-performance materials for numerous daily life uses. 

With more than 1,300 employees across the country, in 2013, Bayer had sales of $1.6 billion and invested $61 million in research and development in Canada. Globally, Bayer AG had sales of €40.2 billion and invested €3.2 billion in research and development.

For more information about Bayer, please visit www.bayer.ca.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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.

[i]	Braithwaite T, Nanji AA, Lindsley K, Greenberg PB. Anti-vascular endothelial growth factor for macular oedema secondary to central retinal vein occlusion (Review). The Cochrane Collaboration, Issue 5 2014.  http://www.updatesoftware.com/BCP/WileyPDF/EN/CD007325.pdf. Last accessed on November 2014
[ii]	CNIB website http://www.cnib.ca/en/your-eyes/eye-conditions/eye-connect/DR/About/Pages/Diabetic-Macular-Edema.aspx last accessed November, 2014.
[iii]	Eylea® Product Monograph, November 2014
[iv]	Petrella, RJ et al. "Prevalence, Demographics, and Treatment Characteristics of Visual Impairment due to Diabetic Macular Edema in a Representative Canadian Cohort," Journal of Ophthalmology, vol. 2012, Article ID 159167, 6 pages, 2012. doi:10.1155/2012/159167.
	Minassian DC et al. Prevalence of diabetic macula edema and related health and social care resource use in England. Br J Ophthalmol. 2012 Mar;96(3):345-9
[v]	CNIB website http://www.cnib.ca/en/your-eyes/eye-conditions/eye-connect/AMD/About/Pages/default.aspx last accessed November, 2014.
[vi]	Foundation Fighting Blindness website http://www.ffb.ca/eye_conditions/amd_center/what_amd.html last accessed November, 2014.
[vii]	Canadian Ophthalmological Society website http://www.cos-sco.ca/vision-health-information/conditions-disorders-treatments/retinal-diseases/amd/ last accessed November, 2014.

SOURCE: Bayer Inc.

For further information: Communications Contacts: Marija Mandic, Bayer Inc., [phone], [email protected]; David Airdrie, Hill+Knowlton Strategies, 416-413-4745, [email protected]

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