New Therapy Approved by FDA for Diabetic Macular Edema

On August 10th, the FDA approved the use of ranibizumab (Lucentis), to treat diabetic macular edema (DME). This drug blocks a protein called VEGF, or vascular endothelial growth factor. VEGF is a protein usually involved in formation of blood vessels, but in people with diabetic eye disease, the levels of this protein can be too high causing leaky blood vessels and contributing to DME. Lucentis is one of several drugs developed to block VEGF, and is now the first drug therapy to be approved by the FDA for DME. Compared to standard laser photocoagulation therapy, clinical trials have shown that Lucentis has the potential to improve rather than just stabilize vision in many people with DME. The success of anti-VEGF therapy in DME also represents a critical insight into the biological pathways that cause diabetic eye disease. VEGF is now validated as a single protein that can be targeted to block the disease, which gives us more confidence that we can find other such targets to develop drugs both for different stages of eye disease, as well as in those who do not respond to anti-VEGF therapy. Lucentis was previously approved in the US and Europe for treatment of another eye condition, wet age-related macular degeneration, and in Europe for DME.

Reference:

FDA press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm315130.htm

Investigators and Institutions:

Genentech, Inc., CA

Ramifications for Individuals with Type 1 Diabetes:

People with T1D are at risk for diabetic eye disease, including DME, which can cause significant loss of vision and, in extreme cases, even blindness. Laser therapy has been used as standard treatment for the past few decades and has dramatically helped to reduce blindness. However, laser photocoagulation is not a perfect therapy, and though it can in many cases prevent people with DME from losing even more vision, it very rarely improves vision. Anti-VEGF therapies, such as Lucentis, have been shown in clinical trials to preserve and even improve vision in those with DME.

JDRF Involvement:

JDRF funded multiple research grants in the 1990s which helped establish the basic role for VEGF in diabetic eye disease. Since then JDRF has also been involved in supporting and funding numerous clinical studies including through the Diabetic Retinopathy Clinical network, the READ, READ-2 and READ-3 studies led by Dr. Quan Nguyen at Johns Hopkins Medical Institute, which helped demonstrate that anti-VEGF can treat diabetic macular edema, as well as advocating for those with T1D and eye disease. JDRF did not directly support Genentech in the clinical development and commercialization of Lucentis and does not endorse the use of this product.