PATIENT ADVOCACY / DIABETIC MACULAR EDEMA
Diabetic Macular Edema (DME) is one of the largest causes of vision loss in the developed world and is one of several diabetic eye diseases. Diabetic eye disease refers to a group of eye problems that people with diabetes may face as a complication of diabetes. All can cause severe vision loss or even blindness.
Diabetic eye disease may include:
- Diabetic retinopathy : damage to the blood vessels in the retina.
- Cataract : clouding of the eye's lens. Cataracts develop at an earlier age in people with diabetes.
- Glaucoma : increase in fluid pressure inside the eye that leads to optic nerve damage and loss of vision. A person with diabetes is nearly twice as likely to get glaucoma as other adults.
In some people with diabetic retinopathy, blood vessels may swell and leak fluid. In other people, abnormal new blood vessels grow on the surface of the retina. The retina is the light-sensitive tissue at the back of the eye. A healthy retina is necessary for good vision. When fluid leaks into the center of the macula, the part of the eye where sharp, straight-ahead vision occurs, the fluid makes the macula swell, blurring vision. This condition is called macular edema. It can occur at any stage of diabetic retinopathy, although it is more likely to occur as the disease progresses.
DME affects approximately one million people in the U.S. alone. Currently, the only FDA approved method for treating DME involves laser photocoagulation therapy, which can leave irreversible blind spots.
pSivida, has completed Phase III clinical trials for ILUVIEN (R), our lead development product. ILUVIEN is an injectable, non-erodable, intravitreal implant for the treatment of DME and releases the drug fluocinolone acetonide (FA) for periods up to 36 months. These trials called the FAME study (Fluocinolone Acetonide in Diabetic Macular Edema), were conducted in conjunction with our partner Alimera Sciences Inc. Our jointly owned NDA was recently submitted to the FDA.
