pSivida has developed three FDA-approved products utilizing our proprietary Durasert™ Technology to treat serious back-of-the-eye diseases. We are currently in late-stage development of a Durasert three-year product to treat posterior uveitis.
We are utilizing our Durasert bioerodible technology platform in collaboration with other pharmaceutical companies to develop new sustained-release products to treat retinal diseases and other ocular conditions.
We are expanding our focus beyond eye diseases to leverage our Durasert Technology for the treatment of musculoskeletal conditions, beginning with osteoarthritis of the knee.
|Durasert three-year treatment for posterior segment uveitis||Phase 3|
|Duraseret shorter duration treatment for posterior segment uveitis||Preclinical|
|Durasert TKI for Wet AMD||Preclinical|
|Durasert Knee OA||Phase 1|
|Front of the eye disease||Preclinical|
|Back of the eye disease||Preclinical|
ILUVIEN® is an injectable, non-erodible, intravitreal implant for the treatment of diabetic macular edema (DME), a serious condition that can lead to blindness. DME affects approximately one million people in the U.S. alone. ILUVIEN® utilizes pSivida’s proprietary third generation Durasert™ Technology. It is specifically designed to release the corticosteroid fluocinolone acetonide (FA) for up to three years with a single injection to the back of the eye.
ILUVIEN is licensed to Alimera Sciences, Inc. The U.S. Food and Drug Administration (FDA) approved ILUVIEN for the treatment of DME for patients who did not have a significant rise in intraocular pressure (IOP) when treated with a course of corticosteroids.
Additionally, ILUVIEN for DME has received marketing authorization in 17 EU countries, where it is approved for use in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
Durasert™ Three-year for Posterior Uveitis
pSivida is currently in late-stage clinical development of a three-year sustained-release fluocinolone acetonide product in the proven Durasert™ Technology for the treatment of posterior uveitis. Posterior uveitis is a chronic, non-infectious inflammation of the posterior segment of the eye that can lead to blindness. The first Phase 3 study enrolled 129 patients and met its primary endpoint, prevention of recurrence of posterior uveitis, at six months with high statistical significance. Data at 12 months from the same study demonstrated sustainability of the treatment effect. The second Phase 3 study completed enrollment of a total of 153 patients in October of 2016 and results are expected late in the 2nd quarter of 2017. pSivida expects to file in the EU during the first half of 2017 and in the U.S. during the second half of 2017. pSivida plans to commercialize the product in the U.S. and is currently seeking a partner to commercialize the product in the EU and other markets outside the U.S.
Durasert™ Shorter Duration for Posterior Uveitis
pSivida is currently developing a shorter-duration sustained-release fluocinolone acetonide product in the proven Durasert™Technology for the treatment of posterior uveitis. Posterior uveitis is a chronic, non-infectious inflammation of the posterior segment of the eye that can lead to blindness. The shorter duration product will provide retina and uveitis specialists with an additional treatment option to gauge patient response to therapy before using a longer-duration device.
Durasert™ Bioerodible TKI
Wet AMD remains an area of great unmet medical need. pSivida is focused on developing a sustained-release bioerodible device containing a tyrosine kinase inhibitor (TKI) to assess its potential to treat wet AMD. In-vitro release profiles have been assessed for several TKIs. pSivida is actively seeking partners interested in advancing the program to clinical-stage development.
Durasert™ for Knee Osteoarthritis (OA)
pSivida is working with the Hospital for Special Surgery (HSS) in New York City to assess the safety and efficacy of a titanium screw drug implant containing the corticosteroid dexamethasone to treat pain associated with severe osteoarthritis of the knee. The screw implant utilizes the Durasert™ Technology and is designed to release a low dose of dexamethasone for approximately one year. This investigator-initiated study is being conducted by HSS. A total of 6 patients have been enrolled as of the 2nd quarter of 2017 and will be followed for a period 6 months. In addition to safety, the study will evaluate efficacy parameters such as relief of pain and improvements in stiffness and function. If found effective, the implant could provide long-term pain relief and potentially delay the need for knee replacement surgery. Osteoarthritis of the knee affects millions of patients in the U.S and current treatment options to manage pain, including systemic administration of opioids and NSAIDs, are associated with potentially serious side effects. Current injectable steroids provide relief for only 10-12 weeks, thus necessitating multiple injections and office visits.