TORONTO, Canada, November 27, 2018 – Interface Biologics Inc. (“IBI”), a privately held, commercial stage developer of innovative material science technologies for Medtech and Pharmaceutical applications, is pleased to announce a positive pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) for its novel dexamethasone intravitreal implant for the treatment of posterior inflammatory eye diseases.
The FDA concurred with IBI’s manufacturing and clinical development plans, based on the pre-clinical testing presented in the pre-IND submission. Furthermore, the FDA has determined that the 505(b)(2) pathway as an acceptable regulatory route for future approval of the IBE-814 IVT Implant, a sustained release, low dose dexamethasone intravitreal implant that IBI is developing for the treatment of inflammatory eye diseases. The 505(b)(2) pathway provides an abbreviated route to product approval in the US with less clinical and preclinical requirements than traditional applications.
The IBE-814 IVT Implant is based on IBI’s exclusive drug delivery technology designed to overcome limitations of current intravitreal therapies. The IBE-814 IVT Implant releases a low, consistent and efficacious dose of dexamethasone for delivery through a 30-gauge needle over a period of 6 months. IBE-814 has been developed to be fully biodegrade within the vitreous without residual remnants or inflammatory degradation products.
“Surface erosion-based drug release is the holy grail of local sustained drug delivery. With our Epidel® technology, Interface Biologics has developed a truly novel surface erodible platform that enables precise control of drug release and duration”, commented Wendy Naimark, Ph.D., Vice President, R&D at Interface Biologics, Inc. “The demonstrated preclinical success of our Dexamethasone Intravitreal Implant, combined with a positive FDA pre-IND meeting sets the stage for validating our vision.”
Following the successful pre-IND interaction with FDA, IBI is preparing to initiate a Phase II trial in patients with diabetic macular edema based on successful preclinical in vivo models that have demonstrated consistent drug release and sustained anti-inflammatory effect.
“That FDA agrees with our CMC approach, planned preclinical testing, and clinical development plan, validates our strategy to quickly and economically advance this novel treatment for patients with potentially blinding diseases and address a growing medical need”, stated Frank Shannon, Vice President, Clinical Research and Regulatory/Quality Affairs. “This early agreement from the FDA is testament to our R&D team’s expertise in planning and execution of critical studies supporting accelerated product development.”
About Interface Biologics, Inc. Interface Biologics (IBI) is an early commercial stage, privately held company that develops innovative materials for Medtech and Pharmaceutical applications. IBI surface modification additives are used in FDA-approved medical devices and are clinically proven to reduce infection and thrombus-related complications. IBI’s sustained local drug delivery technology is applicable across a range of drug classes and medical specialties with an initial focus on ophthalmology.
Julie Fotheringham, Partner, Hageman Communications
M: 416-951-7988 E: Julie.firstname.lastname@example.org