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

The U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for EYLEA® (aflibercept) Injection for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of March 30, 2015.
  
In September 2014, the FDA granted EYLEA® (aflibercept) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with DME. The FDA created the Breakthrough Therapy designation to expedite the development and review of drugs for serious or life-threatening conditions. A Breakthrough Therapy drug must show preliminary clinical evidence of a substantial improvement on a clinically significant endpoint over available therapies, or over placebo if there is no available therapy.
  
The Phase 3 VIVID-DME and VISTA-DME trials, which supported the approval of EYLEA in DME, included a pre-specified secondary endpoint evaluating diabetic retinopathy based on an established grading scale in patients with DME. The two-year results from these trials on the primary endpoint of best-corrected visual acuity (BCVA) and overall safety have been previously reported.
  

EYLEA® (aflibercept) Injection is available as a single, 2 milligram (mg) strength intravitreal injection for all approved indications. EYLEA is approved in the U.S. for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and DME.
  

About the VIVID-DME and VISTA-DME Trials
  
The Phase 3 VISTA-DME and VIVID-DME studies of 862 patients compared EYLEA 2 mg given monthly, EYLEA 2 mg given every two months (after five initial monthly injections), or macular laser photocoagulation (at baseline and then as needed). In the DME studies, at one year, the mean changes in Best Corrected Visual Acuity (BCVA), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart for the monthly and every two month EYLEA groups, were statistically significantly improved compared to the control group and were similar to each other. Across both trials at one year, patients in both EYLEA dosing groups gained, on average, the ability to read approximately two additional lines on an eye chart compared with almost no change in the control group. A secondary endpoint of the trials was the proportion of patients who achieved a 2-step or greater improvement on the ETDRS diabetic retinopathy (DR) severity scale at two years.
  
In these trials, EYLEA had a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across treatment groups and the control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists’ Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across treatment groups and the control group. The most frequent ocular treatment emergent AEs (TEAEs) observed in the VISTA-DME and VIVID-DME trials included conjunctival hemorrhage, eye pain, cataract, and vitreous floaters. The most common nonocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the control group.
  

About EYLEA® (aflibercept) Injection for Intravitreal Injection
  
EYLEA is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. EYLEA is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. EYLEA helps prevent VEGF-A and PLGF from interacting with their natural VEGF receptors as shown in preclinical studies.
  
Source: Yahoo