Epidel® is a novel nonpolymeric small molecule prodrug drug delivery platform which provides for controlled local drug delivery via surface erosion. Epidel materials are engineerable into standalone pharmaceutical implantables (i.e intravitreal implants and micro/nanoparticles) and medical device coatings.
IBE-814 : Dexamethasone-releasing intravitreal implant
IBE-814 is aimed at being best-in-class therapy for the treatment of posterior inflammatory eye diseases, including diabetic macular edema (DME), retinal vein occlusion (RVO) and non-infectious uveitis (NIU). The IBE-814 implant is minimally invasive, delivered through a 30-gauge needle (vs. currently marketed intravitreal sustained-release steroid therapies which range from 22-25 gauge needle delivery). IBE-814 is designed to deliver a low, consistent, efficacious dose for approximately 9-to-12 months. Our goal is to extend clinical benefit while decreasing common steroid-induced adverse events.
Interface Biologics held a positive pre-IND meeting with the FDA in October 2018, securing agreement on a 505(b)(2) regulatory pathway, including an accelerated clinical plan. IBI is currently focused on CMC development to support initiation of a Phase II clinical trial in 2020.