Our proprietary technology, the EyeGate® II Delivery System, utilizes transscleral iontophoresis to deliver optimal therapeutic levels of drug directly into the targeted ocular tissue. It offers a potential alternative to current delivery modalities such as eye drops and ocular injections. More importantly, it overcomes many of the key limitations of such delivery methods, including:
- Eye Drops: low ocular bioavailability, rapid clearance and potential significant patient burden
- Injection: safety risk, adverse patient experience (travel time, companion requirement, extended monitoring / office time prior to discharge) and impact on physician practice due to time and labor-intensive nature of procedure.
- Compact, elegant, and easy-to-use, we believe the EyeGate® II Delivery System has the potential to deliver drugs non-invasively and quickly into the ocular tissues.
Based on technology originating at the Bascom Palmer Eye Institute at the University of Miami, the EyeGate® II Delivery System has been used in over 2,000 clinical treatments to-date, including more than 1,300 treatments delivering our lead therapeutic candidate, EGP-437.
The system utilizes a low-level electrical current to deliver a specified amount of drug for each treatment. Iontophoresis is a concept that dates back to the 18th century, while the first transscleral (across the white of the eye) iontophoretic application for vitreal drug delivery was reported in 1943. The process involves applying an electrical current to an ionizable substance – one capable of carrying an electric charge – to increase its mobility across a biological membrane and, through electrorepulsion, drive a like-charged drug substance into the ocular tissue.
Based on our studies and other published research, ocular iontophoresis is capable of delivering substantially higher ocular drug concentrations than traditional topical applications, leading to greater bioavailability and more sustained therapeutic effect and reducing the frequency of dosing.
For example, based on the current standard of care for anterior uveitis, patients are required to give a minimum of 154 treatments of a topical corticosteroid delivered via drops over a 4-week period. In our Phase 3 non-inferiority trial of EGP-437 administered using the EyeGate® II Delivery System (corticosteroid delivered via iontophoresis), we achieved the same rate of response as the standard of care in only two treatments, with fewer incidences of elevated IOP.
Using our EyeGate® II Delivery System, treatments can be administered by a wider group of eye care practitioners. In-office preparation is simple and efficient, and can be completed by nursing or other office staff. Dosing takes approximately three minutes per eye, while total treatment time including preparation is roughly seven minutes per eye.