The objective of this Phase II proposal is to further develop a novel device for ocular anesthesia based on thermo-electric cooling. Intravitreal injection therapy (IVT) is one of the most commonly performed procedures in all of medicine, with approximately 7 million injections in the USA in 2016. Ocular anesthesia is required, both for patient safety and for tolerability of these vision-preserving injections. To date, all local ocular anesthetics are lidocaine based and function via diffusion of this medication through ocular tissues. Drug diffusion into deeper ocular layers and nerve endings takes between 5-10 minutes and is associated with corneal epithelial toxicity, resulting in post-injection pain and blurred vision. To address the limitations of currently available ocular anesthesia, we have created a device that uses precisely-regulated cold temperatures to deliver focal, ultra-rapid, non-pharmacologic anesthesia to the ocular surface immediately before IVT administration. Pre-clinical device safety testing did not show any evidence of toxicity in rabbits. In addition, our early feasibility study demonstrated proof-of-concept and confirmed safety in humans, with effective anesthesia and no toxicity in study subjects. In this proposal, we aim to further optimize temperature and time point settings of our novel focal anesthesia by thermo-electric cooling (FAnTEC) device in an expanded phase II feasibility study. Data obtained from this trial will be used to design the commercial-ready prototype with a simplified user interface, and this device will be tested in a pivotal phase III clinical trial to support FDA device approval. If successful, this project will lay the groundwork for device manufacturing and commercialization of the FAnTEC device, improving the IVT experience for millions of patients receiving IVT in the United States and around the world. !
The success of intravitreal anti-vascular endothelial growth factor (VEGF) medications for retinal diseases has resulted in an exponential increase in the volume of intravitreal injection therapy (IVT) performed around the world, with over 10 million injections expected in the United States by 2020. The two greatest limitations of IVT are patient pain during and after the injection and, because physician time is constrained, increasingly limited access to care. We have developed a novel system to deliver rapid, focal anesthesia, which reduces side effects and shortens procedure time. If this project is successful, this device will dramatically improve patients' IVT experience while dramatically expanding access to care over the next decade. !