Cagri Besirli, MD, PhD, and Kevin Pipe, PhD
Product Description: A handheld device that employs precision cooling to achieve rapid ocular anesthesia prior to intravitreal injections.
Project Overview: The ability to deliver medication directly into the eye via intravitreal injection therapy (IVT) has transformed the treatment landscape of a number of previously blinding diseases, including macular degeneration and diabetic retinopathy. The success of these therapies has resulted in a dramatic increase in the number of injections performed, with an estimated 8 million injections given in the US in 2014. Prior to injection, anesthesia is administered by either a subconjunctival injection or topical application of a lidocaine-based anesthetic. These methods result in patient discomfort, a higher occurrence of ocular surface bleeding, and delays of 7-10 minutes for complete anesthesia to set in.
In light of this need, Cagri Besirli MD, PhD, Kevin Pipe, PhD, Stephen Smith, MD, and GunHo Kim, PhD, developed the cryoanesthesia device. This device provides ocular surface anesthesia in 30 seconds or less, significantly improving the patient treatment experience. In addition, this device makes it possible for retina specialists to significantly increase the number of patients they can treat in a day, improving patients’ access to sight-preserving care.
This project first received Coulter funding last year for the FY16 cycle. During their first year of Coulter funding, the team developed their first prototype and conducted device safety testing. The team received IRB approval for a first-in-human (FIH) study, which they initiated at the Kellogg Eye Center. This ongoing study is designed to evaluate different temperatures and times for focal ocular surface cooling. With this second year of Coulter funding, the team will use FIH study data and professional market research feedback to further refine the prototype. In addition, they are partnering with a regulatory consultant to prepare for a Pre-Submission meeting with the FDA. One of the goals of the FDA meeting is to obtain guidance for a pivotal second clinical study designed to test the efficacy of cryoanesthesia versus current methods of ocular anesthesia. The clinical efficacy study will be conducted at the Kellogg Eye Center using the newly refined prototype design.
Link to technology at UM Tech Transfer: http://inventions.umich.edu/technologies/6401_applicator-for-cryo-anesthesia-and-analgesia
Email Thomas Marten (tmarten@umich.edu) for more information.