Eylea has been approved for use of Central retinal vein occlusion as well as diabetic macular edema in Canada. Eylea was approved for treatment of wet macular degeneration in November 2011. Since 2011 Eylea has received FDA approval for treatments of Branch Retinal Vein Occlusion(BRVO) and Diabetic Macular Edema(DME)  in the United States and Japan. It is wonderful when one medication can be used to treat several different eye diseases with good outcomes. About Eyelea:  EYLEA (aflibercept) 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 formulated as an iso-osmotic solution for intravitreal administration. – MDA
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
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 16th 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. 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.
Diabetic Macular Edema (DME) Approval
The Health Canada approval of Eylea® for the treatment of DME is based on the results of two Phase III clinical studies (VIVIDDME and VISTADME). 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 VISTADME 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……
Read more: http://www.news-medical.net/news/20141201/Eylea-receives-Health-Canada-approval-for-treatment-of-CRVO-and-DME.aspx
Source: News Medical