Eylea receives Health Canada approval for treatment of CRVO and DME

Bayer Inc.Dec 1 2014

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 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. 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 (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 Approval
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.