Treatment for Diabetic Eye Disease Moves Ahead to Regulatory Review in Europe

Last week JDRF announced that Lucentis, a drug that will treat diabetic macular edema has been submitted for approval to the European Union’s regulatory agency one year early.  The submission is based on strong, positive results from Phase II clinical trials, including ones funded by JDRF.

People living with diabetes are at risk for the development of eye problems including cataracts and glaucoma.  Over time, diabetes affects the circulatory system of the retina.  Macular edema is a major manifestation of diabetes and it leads to vision loss and blindness. In the United States diabetic retinopathy is the number one cause of blindness among people between the ages of 20 and 65.  Aside from controlling blood sugar levels, there are several treatments available for diabetic retinopathy, including laser photocoagulation and other laser and conventional surgical procedures

Lucentis works by blocking the effects of a protein which causes leakage in the eye’s tiny blood vessels which cause blurring and loss of vision.  Lucentis is currently approved for treating age-related macular degeneration.  JDRF has been involved with developing Lucentis as a treatment for diabetic eye disease for several years.

My dad is currently being treated for macular degeneration with Lucentis.   He has had three intraocular injections of Lucentis and he says they are easy.  Is Lucentis available to those who have diabetes related macular edema on a compassionate basis?  Or has macular edema associated with diabetes been treated with Avastin off label as have people with age related macular degeneration?

This, of course, raises the issue of the cost of Lucentis.  Lucentis is being developed by Genentech and the Novartis Ophthalmics Business Unit for diseases or disorders of the eye. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world.  A single dose of Lucentis costs $1950.  Granted one can not put a value on eye sight.  Does this cost seem crazy to anyone else?  Will the price come down when Lucentis is approved for treating macular edema caused by diabetes since many more people may begin to use the medicine?  Or will it remain out of reach for people who do not have adequate insurance?  Will macular edema continue to be treated with Avastin?