Health Canada recently approved anti-VEGF agent alibercept (Eylea) 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.

“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.”

DME is a significant causes of vision loss in Canada. It is estimated that vision impairment resulting from DME affects approximately 2.5 percent 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.

“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.”

Source: BusinessWeek