Humidifeye Plug for Dry Eye Disease

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Project Summary More than 16 million Americans have been diagnosed with Dry Eye Disease (DED). This number is growing due to aggravating factors like increased screen time, and an aging population. It already has an estimated impact of $6.58 billion on the US healthcare system and $70 billion overall economic impact due to decrease in productivity. Two contributing factors to this burden are the price an inadequacy of existing treatments. Common treatments include pharmaceutical drops, lubricant drops, and punctal plugs. Collectively, these therapies are plagued by poor compliance, poor efficacy, discomfort, and untenable costs. Pharmaceutical drops (i.e. Cyclosporine) can also take months to achieve an effect. Punctal plugs offer rapid symptom relief but are prone to sizing issues, patient discomfort, and in some cases the need for surgical removal. They are made in approximately the same designs and with the same materials as at their invention over forty years ago. Our objective is to develop a patient-adaptable punctal plug using environmentally sensitive hydrogels which exhibit a reverse phase transition. An abundance of literature, including prior academic research by members of our team, illustrates the desirable properties of N- isopropylacrylamide copolymers for biomedical applications. The majority of these applications are aimed at drug release, and to-date no one has designed a material suitable for a long-term medical insert. Durability, reliable long-term transition behavior, and scalable manufacture and processing are all functional barriers to development. The AesculaTech team developed an early model of such a material and a prototype applicator which can store it for two months. When inserted, the plug flows into the duct as a liquid, molding to patient anatomy before solidifying. Upon a standard irrigation procedure, this material reverts back to flowable gel for removal. Short term early data has also shown preliminary biocompatibility. As a new medical material, this plug requires optimized and reliable behavior for commercially competitive long-term use. If this project is successful, it will provide a wealth of information on new responsive hydrogels and produce a plug which improves outcomes and provides a safer and easier alternative for most patients. Phase 1 will research new smart hydrogels, using rheology and simulated use to identify a commercially suitable material. The Applicator will also be optimized for usable shelf-life. Phase 2-1 will rigorously test the chemical and biological safety of the device using extract-based and direct contact methods along with generating a list of contraindicated products. Phase 2-2 will clinically validate the performance of the product.