pSivida is a specialty pharmaceutical company focused on the development of innovative miniaturized, sustained-release drug delivery products and technologies to treat serious, debilitating diseases of the eye that can lead to blindness. PSDV’s proprietary Durasert Technology allows for sustained-release delivery of small molecules for up to three years with a single injection. They have developed three of the only four products FDA approved for the long-term, sustained-release delivery of drug to treat chronic back of the eye diseases. Their strategy is to use their Durasert platform to independently develop new drug delivery products that use already approved drugs to better treat ophthalmic and other diseases, while continuing to leverage their technology platform through collaborations and licenses with leading pharmaceutical and biopharmaceutical companies, institutions and others.
Durasert three-year for posterior segment uveitis represents their lead product candidate and has met its primary efficacy endpoint of prevention of recurrence of uveitis through six months (p<0.001) in two ongoing pivotal Phase 3 trials. They anticipate filing an NDA with the FDA by late 4Q17 or early 1Q18. The company is also developing a next-generation Durasert shorter-acting version, initially for the treatment of posterior segment uveitis. They recently amended new collaboration agreement with Alimera Sciences (ALIM) to license distribution, regulatory and reimbursement for Durasert three-year uveitis for EMEA to ALIM. After filing MAA in Europe in June, PSDV withdrew their application after out-licensing their EU rights for Durasert to ALIM. ILUVIEN for diabetic macular edema (DME) is their lead licensed product and is sold in the U.S. and certain EU countries. In their recent deal with ALIM, PSDV converted their license consideration from a share of ALIM’s net profits for ILUVIEN to a royalty based on ALIM’s net sales of ILUVIEN for DME. Additionally, PSDV has FDA-approved Retisert, which is an implant that provides sustained treatment of posterior segment uveitis for 30 months and was co-developed with and licensed to Bausch & Lomb.
PSDV is also using their Durasert technology to identify potential product candidates for wet and dry age-related macular degeneration (AMD), glaucoma, osteoarthritis (OA) and other diseases. In fact, they are working with the Hospital for Special Surgery (HSS) to assess the efficacy of a titanium screw drug implant to treat pain associated with severe OA of the knee.