In addition to treatment for DME, Iluvien is being studied in several clinical trials with retinal specialists to determine its safety and efficacy for other retinal diseases. One area we are pursuing is the treatment of wet age related macular degeneration (wet AMD). Wet AMD occurs when abnormal blood vessels behind the retina start to grow under the macula, a small portion of the retina responsible for our detailed vision. These new blood vessels tend to be very fragile and often leak blood and fluid, elevating the macula and causing damage and loss of vision. Wet AMD, also known as advanced AMD, can cause central vision to be lost quickly.

We are determining Iluvien's effect on Dry AMD, an earlier stage of AMD and affects 85-90% of people with AMD. Dry AMD is caused by the aging and thinning of the macula, leading to the formation of deposits called drusen.  This deterioration of the retinal pigment epithelial (RPE) cells leads to the loss of critical photoreceptors and vision is compromised. Geographic atrophy is an advanced form of dry AMD. We are also starting a trial to understand the efficacy of Iluvien for retinal vein occlusion or RVO.  Blood is circulated to the retina through only one artery and only one vein. If either vessel or one of their smaller branches is blocked, it is called an occlusion. An occlusion can cause the eye to lose vision, often suddenly.

In addition to these other activities related to the development and commercialization of Iluvien, we have acquired options to exclusive, worldwide licenses of patent applications covering two classes of NADPH (Nicotinamide Adenine Dinucleotide Phosphate) oxidase inhibitors from Emory University. We have exercised our option to acquire a license with respect to one of these classes of NADPH oxidase inhibitors.

We believe that the management of oxidative stress is an important strategy in managing the development and progression of diseases of the eye, and we believe that NADPH oxidase inhibitors have the potential to manage oxidative stress. Oxidative stress is a condition where excess reactive oxygen intermediates generally referred to as reactive oxygen species, or ROS, are produced. The production of ROS is not always pathogenic, however, many researchers believe that when the level of ROS becomes excessive, pathogenic processes are initiated, resulting in diseased tissue. 

NADPH oxidase was identified as the first enzyme system to generate ROS as its primary function. NADPH oxidase has been identified in almost every tissue type and there is a significant amount of scientific literature associating NADPH oxidase activation with many systemic and ocular conditions. In the eye, the inhibition of NADPH oxidase has been shown to prevent or slow pathology in various models of ocular disease, including retinal degeneration, retinal neovascularization, choroidal neovascularization and uveitis. In addition, the presence of NADPH oxidase in corneal epithelial cells implicates it as having a possible role in dry eye, and the activation of NADPH oxidase in certain pollen grains upon hydration implicates its role in allergic conjunctivitis.

Our initial focus is on the use of NADPH oxidase inhibitors to treat dry AMD, particularly the late stage of this condition known as geographic atrophy. We plan to conduct additional testing on the use of NADPH oxidase inhibitors to treat other diseases of the eye, including wet AMD and diabetic retinopathy. We are also pursuing the development, license or acquisition of rights to potential new drugs and delivery mechanisms to address diseases of the eye that are not well managed by current therapies. .