Health Canada approves Eyelea for DME treatment

December 2, 2014

Health Canada recently approved Eylea (aflibercept, Regeneron) for the treatment of diabetic macular edema (DME).

Mississauga, Canada-Health Canada recently approved Eylea (aflibercept, Regeneron) for the treatment of diabetic macular edema (DME).

Eylea is also approved in Canada for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) and for the treatment of patients with wet age-related macular degeneration (AMD).

The drug is also approved in the United States for all three indications.

Eylea receives FDA approval for DME treatment

The Health Canada approval of Eylea for the treatment of DME is based on the results of two Phase III clinical studies (VIVID and VISTA). In both studies, Eylea dosed 2 milligrams monthly and Eylea dosed 2 mg every two months (after five initial monthly injections), achieved the primary endpoint of significantly greater improvements in best-corrected visual acuity from baseline compared to laser photocoagulation at 52 weeks. Further, in the VISTA study, patients gained a mean +12.5 and +10.7 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 administered by intravitreal injection once every four weeks for the first five consecutive doses, followed by one injection every eight weeks.

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 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 four 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 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 three months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy.