Retisert

The Retisert® implant was developed under Dr. Smith at his previous company, Control Delivery Systems, Inc. (now pSiveda).

Using fundamentally the same technology as Vitrasert®, we developed an intraocular sustained release steroid implant capable of maintaining anti-inflammatory intravitreal drug levels for periods of up to 3 years from a single implantation. This device was approved by the FDA in 2005 based on GMP production, release and stability studies; on GLP animal studies in multiple species demonstrating absence of toxicity, efficacy in models of inflammatory disease, and pharmacokinetics; and on two Phase III studies in patients with uveitis.