It was just a few days ago when New York-based Regeneron Pharmaceuticals faced a setback for the supplemental approval of its drug Eylea® (aflibercept), a vascular endothelial growth factor (VEGF) inhibitor. But after completing “labeling discussions,” the U.S. Food and Drug Administration (FDA) has finally given the company the nod for the blockbuster drug as a once-per 12-week treatment for wet age-related macular degeneration (wet AMD).
The treatment works to restrict the ability of fluids to pass through blood vessels in the eye and block the growth of new blood vessels. The updated label now provides information on the potential risk of thromboembolic events, such as vascular death, nonfatal myocardial infarction, and nonfatal stroke, following intravitreal use of VEGF inhibitors, including aflibercept.
Forms of Age-Related Macular Degeneration (AMD)
There are two types of AMD – wet and dry. Wet AMD is rarer and usually accounts for just about 10 to 15 percent of patients with this retinal condition. A person can have wet AMD in one eye and dry AMD in the other eye.
Also referred to as choroidal neovascularization, wet AMD leads to more serious and rapid vision loss. This is attributable to irregular mini-blood vessels emerging beneath the macula and then secreting fluid, resulting in the flat macula to elevate. The patient may notice a blurred gray or black spot in the center of his or her vision and see straight lines as wavy or curvy. Both of these signs interfere with identifying faces, reading, and performing daily tasks.
Standard Treatment for Wet AMD
Traditionally, doctors treat wet AMD with regular eye injections of anti-VEGF drugs. For people with AMD, VEGF is a protein secreted at a higher than normal levels in the body’s hapless attempt to deliver oxygen to deprived retinal cells. The three most popular anti-VEGF medications include Avastin, Lucentis, and the most recent one, Eylea. These treatments help inhibit and block the growth of new, but undesirable and abnormal blood vessels for those with diabetic retinopathy and wet AMD.
Eylea Injections at 12-week intervals
The standard dose for Eylea is two milligrams administered by intravitreal injection. Regeneron recommends taking it every 4 weeks (monthly) for the first 12 weeks (3 months), followed by two milligrams once every 8 weeks (2 months). Because of the inconvenience, cost, and eye irritation, many clinical trials aim to reduce the frequency of eye injections but maintain the same or better results to the patient’s eyesight. It seems that goal is making progress for those who are receiving Eylea.
The pharmaceutical company reported that the two-year results from their VIEW 1 and VIEW 2 phase 3 trials showed that 51 percent of patients under the standard therapy kept their best corrected visual acuity gains at the beginning of the second year.
With the therapy offering promising results and making the intervals between injections and visits to the eye doctor longer, patients with wet AMD can enjoy a more fruitful and convenient way to recovery. The updated information on the visual outcomes of the modified 12-week dosing schedule will help also retinal physicians make the most informed choices for their patients.
Sources:
https://www.regeneron.com/sites/default/files/EYLEA_FPI.pdf
