I-Corps: Lens-mediated Delivery of Therapy for Dry Eye Disease

The broader impact/commercial potential of this I-Corps project is the development of technologies to treat dry eye disease. Current treatments for dry eye disease are largely limited to over-the-counter relief (artificial tears) or prescription medications targeting the adaptive immune system. Artificial tears do not address the cellular and inflammatory mechanisms of dry eye disease and do not offer long-term relief. Prescription medications broadly target T cell migration, proliferation, activation, and inflammatory mediator secretion. However, these treatments have side effects including burning, irritation, and blurry vision. They also require frequent instillation of drops, which, coupled with side effects, may result in treatment non- compliance. In addition, bolus delivery and medication loss are major limitations of eye drops, as the therapeutic agent is only in contact with the ocular surface for a short period, limiting efficacy. The proposed technology uses a dual immune and goblet cell fate modulator medication and improved drug delivery via a coating applied to soft contact lenses. A therapeutic that effectively addresses dry eye disease may improve patient outcomes. This I-Corps project is based on the development of a short-term, low-dose, single cytokine treatment for dry eye disease coupled with a contact lens-mediated delivery method. The proposed technology modulates both innate and adaptive immunity, and concurrently improves tear film stability by restoring goblet cell number and function. This approach includes the use of interleukin 4 (IL-4) as a dual immune and goblet cell fate modulator and improved drug delivery via a tunable nanoscale biopolymer coating applied to soft contact lenses. The proposed lens-mediated delivery technology includes an electrostatic layer by layer polymeric coating that complexes, protects, and steadily releases small amounts of cytokine at the ocular surface. This approach has the potential to provide increased efficacy over current approaches that seek symptomatic relief or inhibition of T cell activation broadly. In addition, the lens-mediated delivery vehicle has benefits over medicated eye drops as the coating may more effectively deliver IL-4 directly to the ocular surface. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.