The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved aflibercept (EYLEA®) Injection for diabetic macular edema (DME).
 
EYLEA has already been approved in Japan for the treatment of patients with neovascular age-related macular degeneration (wet AMD), macular edema secondary to central retinal vein occlusion (CRVO), and myopic choroidal neovascularization (myopic CNV). A marketing authorization application has been submitted in Japan for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO).
 
EYLEA is approved in the U.S. for wet AMD, DME and macular edema following retinal vein occlusion (RVO).
 
EYLEA has been approved in almost 80 countries for the treatment of patients with wet AMD and around 60 countries for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion. EYLEA is also approved for the treatment of DME in over 30 countries. An application has been submitted for marketing authorization in Europe for EYLEA in macular edema following BRVO.
 
About Diabetic Macular Edema (DME) 
Diabetic macular edema (DME) or “swelling of the macula” is a common complication in the eyes of patients with diabetes. It is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness. Visual impairment due to DME is estimated to affect around three percent of people with diabetes around the world and is the most frequent cause of blindness in young and mid-aged adults in most developed countries.
 
DME occurs when blood vessels in the retina are damaged by chronic high blood sugar levels caused by diabetes. This allows fluid from blood vessels to leak into the retina, causing macular swelling. Fluid in the macula can cause severe vision loss or blindness. The macula is the part of the retina responsible for central, fine vision.
 
Vascular endothelial growth factor (VEGF), a naturally occurring family of growth factors in the body, appears to play a critical role in the development of DME. Increased VEGF production contributes to the vascular disruptions and leakage that characterize DME.
 
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.
 
EYLEA is for prescription use only. For additional safety information, see the full Prescribing Information for EYLEA.
 
Source: Yahoo

In the National Institutes of Health (NIH) sponsored, Diabetic Retinopathy Clinical Research Network (DRCR.net) comparative effectiveness study in patients with Diabetic Macular Edema (Protocol T), EYLEA® (aflibercept) Injection demonstrated a significantly greater improvement in mean change in best-corrected visual acuity (BCVA) from baseline at 52 weeks compared to both bevacizumab (Avastin® /Genentech) and ranibizumab injection (Lucentis®/Genentech), the primary endpoint of the study. The median number of injections using the protocol-specified retreatment regimen was one fewer in patients treated with EYLEA compared to bevacizumab and ranibizumab. Fewer patients in the EYLEA group received criteria-based macular laser treatments than those treated with bevacizumab and ranibizumab.
 
The rates of most ocular and systemic adverse events (AEs) were similar across the three study groups. The rates of arterial thromboembolic events as defined by the Anti-Platelet Trialists’ Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) in the trial were 2 percent in the EYLEA group, 4 percent in the bevacizumab group and 5 percent in the ranibizumab group. There were more overall cardiovascular events in the ranibizumab group, compared to the EYLEA group and the bevacizumab group (nominal p less than 0.01); this included more cardiac events and cerebrovascular events in the ranibizumab group.
 
DRCR.net has shared these top-line results with study investigators. DRCR.net is in the process of finalizing and verifiying the data prior to submission for publication.
 
The independent, government-sponsored study was designed to determine if one of three different anti-VEGF therapies is superior to the others for the treatment of diabetic macular edema (DME). In the study, 660 patients were randomized to receive either EYLEA 2 milligrams (mg), bevacizumab 1.25 mg, or ranibizumab 0.3 mg dosed according to a protocol-specified algorithm. Patients were treated with focal/grid laser at or after the 24 week visit if: 1) the OCT central subfield thickness was greater than or equal to 250 microns or there was edema that was threatening the fovea and 2) the eye did not improve on OCT or visual acuity from the last two consecutive injections. Full details of the protocol can be found at www.drcr.net.
 
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.
 
 

IMPORTANT PRESCRIBING INFORMATION FOR EYLEA® (aflibercept) INJECTION
 
EYLEA® (aflibercept) Injection is a prescription medicine approved for the treatment of patients with:
 
• Wet Age-related Macular Degeneration (AMD): The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 3 initial monthly (4 weeks) injections. EYLEA may be dosed once per month, but additional benefit was not seen with this dosing plan.
 
• Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose for EYLEA is 2 mg administered by injection in the eye monthly (every 4 weeks).
 
• Diabetic Macular Edema (DME): The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 5 initial monthly (4 weeks) injections. EYLEA may be dosed once per month, but additional benefit was not seen with this dosing plan.
 
 

IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION
 
EYLEA® (aflibercept) Injection is a prescription medication administered by injection into the eye. Patients should not use EYLEA if they have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept. As with all medications, EYLEA can cause side effects.
 
Injection into the eye can result in an infection in the eye and retinal detachment. Inflammation in the eye has been reported with the use of EYLEA.
 
In some patients, injections with EYLEA may trigger a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and doctors may monitor this after each injection.
 
There is a potential risk of serious and sometimes fatal side effects related to blood clots, leading to heart attack or stroke in patients receiving EYLEA.
 
Serious side effects related to the injection procedure are rare but can occur including infection inside the eye and retinal detachment.
 
The most common side effects reported in patients receiving EYLEA are increased redness in the eye, eye pain, cataract, moving spots in the field of vision, increased pressure in the eye, and vitreous (gel-like substance) detachment.
 
It is important that patients contact their doctor right away if they think they might be experiencing any side effects.
 
EYLEA is for prescription use only. For additional safety information, please see the full Prescribing Information for EYLEA.
 
Source: Yahoo