20 Apr VEGF-Trap Gets Closer to FDA Approval
VEGF-Trap (aka aflibercept), another anti-VEGF drug, moves closer to FDA approval as it received “priority review” status. This status means that the FDA process will be accelerated and the drug can be reviewed in 6 months versus the usual 10 month period. Alfibercept is another injectable drug that may have an effect on choroidal neovascularization in wet macular degeneration.
In the press release, Regeneron Pharmaceuticals, Inc., cited an incidence of almost 200,000 new cases of wet ARMD in the U.S. alone. It is the leading cause of new blindness in patients 65 and older.
As with it’s predecessors, Macugen and Lucentis, the company must prove to the FDA that the drug is effective and safe.
Regeneron has also started Phase III clinical trials for VEGF-Trap for the treatment of diabetic macular edema. There will be two studies, an international study and a North American study. These trials, too, will be conducted to test the safety and efficacy of alibercept for retinal swelling caused by diabetic retinopathy, or diabetic macular edema.
Diabetic macular edema is the leading cause of decreased vision in patients with diabetes under the age of 50. Similar studies are underway for Lucentis and Avastin.
What Does This Mean?
On one hand, this is not new news. Macugen, Lucentis and Avastin have been used for several years for the treatment of wet macular degeneration. VEGF-trap is the same type of drug as the aforementioned. VEGF-trap is likely, in my opinion, to gain FDA approval if; it improves vision better than Lucentis and/or it requires fewer repeat injections to stableize the eye.
On the other hand, using VEGF-Trap for the treatment of diabetic retinopathy will be the first drug to gain FDA approval. Until now, we (retinal specialists) have been using Avastin and Lucentis “off label” for the treatment of DME. Approval of VEGF-Trap will validate our suspicions that this is a worthwhile treatment for diabetic retinopathy.