Aerie is currently exploring sustained-release drug delivery technology to treat diabetic macular edema (DME). Our product candidate AR-1105 is an intravitreal, fully biodegradable PRINT®-manufactured implant that releases the steroid dexamethasone. Our expectation is that this implant will provide a six-month duration of action, thereby reducing treatment burden relative to other treatments for DME.1
We filed an Investigational New Drug (IND) application for AR-1105 in December 2018. The FDA has reviewed the IND and it is now in effect. A Phase 2 study in the treatment of macular edema due to retinal vein occlusion (RVO) will be initiated in Q1, 2019.
About Diabetic Macular Edema
DME is an accumulation of fluid in the macula resulting from leaking blood vessels. DME is a manifestation of diabetic retinopathy, which causes damage to retinal vessels and vision impairment. Driven by rising rates of diabetes, the number of cases of diabetic retinopathy in the United States is expected to nearly double by 2050, rising from 7.7 million to 14.6 million.1 Approximately half of all people with diabetic retinopathy will develop DME.2
1. Data on file. 2. National Eye Institute. Diabetic Retinopathy. National Institutes of Health. https://nei.nih.gov/eyedata/diabetic. Accessed January 9, 2018. 3. National Eye Institute. Facts About Diabetic Eye Disease. National Institutes of Health. https://nei.nih.gov/health/diabetic/retinopathy. Accessed January 9, 2018.