Eylea® (aflibercept, solution for intravitreal injection) offers new
hope for patients suffering from wet age-related macular degeneration
TORONTO, Nov. 12, 2013 /CNW/ - Bayer Inc. announced today that it has
received approval from Health Canada for Eylea® (aflibercept, solution for intravitreal injection) for the treatment of
patients with neovascular (wet) age-related macular degeneration (wet
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 cause a sudden loss of 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. 1,2
"The approval of Eylea in Canada is great news for the increasing number
of patients suffering from wet AMD, a sight-threatening eye condition,"
said Dr. David T. Wong, MD, FRCSC Associate Professor of Ophthalmology
and Vision Sciences, St. Michael's Hospital, University of Toronto.
"The dosing of Eylea every two months has the potential to
significantly reduce the burden for patients living with this
devastating disease by giving them more time to do the things they like
"The approval of Eylea in Canada means that patients with wet AMD will
have more treatment options to help them to continue to live fulfilling
lives," said Sharon Colle, President & CEO of the Foundation Fighting
Blindness. "The potential for less frequent office visits with this new
treatment will mean a lot to patients and their families."
The Health Canada approval of Eylea® is based on the results of two Phase III clinical studies (VIEW 1 and
VIEW 2) which demonstrated that aflibercept injection dosed every 8
weeks, following 3 initial monthly injections, was non-inferior to
ranibizumab injection dosed every 4 weeks. This was measured by the
primary endpoint of proportion of subjects who maintained vision (i.e.
loss of fewer than 15 letters of best-corrected visual accuity compared
to baseline) at week 52. The most common adverse reactions (frequency
of 5.0% or more) reported in patients receiving aflibercept injection
were conjunctival hemorrhage, eye pain, cataract, vitreous detachment,
vitreous floaters, and increased intraocular pressure.
Bayer Inc. plans to launch Eylea® in January 2014, and has initiated efforts to gain early and rapid
reimbursement for this new product.
About VEGF and VEGF Trap-Eye (aflibercept, solution for intravitreal
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. Scarring and loss of
fine-resolution central vision often results.
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. VEGF Trap-Eye
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® is already approved in the United States, Europe, Japan, Australia, and
many other countries for use in wet AMD and in the U.S., Europe, and
several countries in South America for the treatment of macular edema
Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating
on the global development of Eylea®. Regeneron maintains exclusive rights to Eylea® in the United States. Bayer HealthCare has licensed the exclusive
marketing rights outside the United States, where the companies share
equally the profits from sales of Eylea®, except in Japan where Regeneron receives a royalty on net sales.
About Wet AMD
Age-related macular degeneration (AMD) is a leading cause of acquired
blindness. Macular degeneration is diagnosed as either dry
(non-exudative) or wet (exudative). In wet AMD, new blood vessels grow
beneath the retina and leak blood and fluid. This leakage causes
disruption and dysfunction of the retina creating blind spots in
central vision, and it can account for blindness in wet AMD patients.
About The Foundation Fighting Blindness
The Foundation Fighting Blindness is Canada's largest charity for
sight-saving research and has contributed over $24 million to find the
causes, treatments and cures for retinitis pigmentosa, macular
degeneration and related blinding eye diseases. You'll see: results thanks to Foundation-funded discoveries, made possible by its generous
donors. The Foundation is also known by its signature events: Comic
Vision, Cycle for Sight, Ride for Sight, and Vision Quest. Visit
ffb.ca or call 1.800.461.3331 for the latest in vision research.
About Bayer in Canada
Bayer Inc. is a Canadian subsidiary of Bayer AG and the corporate
headquarters for the Canadian operations. Celebrating its 150th anniversary, 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 Toronto, 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 2012, Bayer had
sales of $1.6 billion and invested $55.9 million in research and
development in Canada. Globally, Bayer AG had sales of €39.8 billion
and invested €3 billion in research and development.
For more information about Bayer, please visit www.bayer.ca.
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
1 CNIB website http://www.cnib.ca/en/your-eyes/eye-conditions/eye-connect/AMD/About/Pages/default.aspx last accessed October 16, 2013.
2 Foundation Fighting Blindness website http://www.ffb.ca/eye_conditions/amd_center/what_amd.html
last accessed October 25, 2013
SOURCE: Bayer Inc.
For further information:
Your Contact at Bayer:
Laura Burns, 416-240-5484