Aflibercept (Eylea) Improves Diabetic Eye Condition
Positive one-year results from two phase III trials (August 6)
In two similarly designed trials (VIVID-DME and VISTA-DME), patients with diabetic macular edema (DME) who received aflibercept (Eylea, Regeneron/Bayer) showed greater improvement in vision than those treated with laser photocoagulation.
DME is a common complication of diabetic retinopathy, a disease affecting the blood vessels of the retina. DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness.
Vascular endothelial growth factor (VEGF) is a naturally occurring protein in the body. In patients with DME, hyperglycemia-induced vascular dysfunction and hypoxia cause elevated intraocular VEGF levels in the eye and permeable blood vessels, leading to macular edema, which can result in vision loss.
The FDA approved aflibercept to treat age-related neovascular (wet) macular degeneration in 2011 and macular edema following central retinal vein occlusion in 2012. The drug is a recombinant fusion protein that inhibits blood vessel growth in the eye. Regeneron plans to submit a marketing application for the DME indication later this year.
In the trials, patients received aflibercept 2 mg injected intravitreally monthly, 2 mg every other month at after five initial monthly injections, or laser photocoagulation. Patients receiving aflibercept gained best-corrected visual acuity of more than 10 letters on a standard eye chart, on average, compared with less than two letters in the control groups receiving the laser procedure.
The drug was generally well tolerated. Adverse-event rates were similar for the three arms in both studies. The most common adverse events were conjunctival hemorrhage, eye pain, and vitreous floaters. Non-ocular events included hypertension and nasopharyngitis.
Both trials are planned to continue for up to 148 weeks.
DME is the most frequent cause of blindness in young and middle-aged adults.
Source: Regeneron; August 6, 2013.