pSivida is a Watertown, Massachusetts company specializing in the application of micro-electromechanical systems and nanotechnology to drug delivery. The company is a specialty pharmaceutical organization that is focused on the development of innovative miniaturized, sustained-release drug delivery products, and technologies. These products treat serious, debilitating diseases of the eye that can lead to blindness. The dedicated team of scientists at pSivida has developed three of the only four products approved by the FDA for the long-term, sustained-release delivery of drug to treat chronic back of the eye diseases.
Star Product: Durasert Technology
pSivida specializes in the development of miniaturized, sustained-release drug devices to treat debilitating diseases of the eye and other localized, chronic conditions, such as osteoarthritis of the knee. pSivida’s proprietary Durasert™ Technology allows for sustained-release delivery of small molecules for up to three years with a single injection. The technology has been utilized in three FDA-approved products to treat serious back-of-the-eye diseases.
The Durasert™ Technology is a miniaturized, injectable, sustained-release drug delivery system for small molecules that can last for up to three years. pSivida’s primary Durasert Technology is only 3.5mm in length with a diameter of just 0.37mm. The implant can be administered in an office setting through a needle as small as 25-gauge. To date, three products utilizing the technology have been approved by the FDA to treat serious back-of-the-eye diseases. These products include ILUVIEN®, licensed to Alimera Sciences, and RETISERT® and VITRASERT®, licensed to Bausch & Lomb. The company is currently in late-stage development of a Durasert three-year product to treat posterior uveitis.
“We are utilizing our Durasert bio-erodible technology platform in collaboration with other pharmaceutical companies to develop new sustained-release products to treat retinal diseases and other ocular conditions,” explains Nancy Lurker, President and Chief Executive Officer of pSivida. “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,” she adds.
Durasert Technology for the delivery of small molecules provides the following:
The Success Vision
pSivida has completed two Phase 3 studies to support U.S. registration of its Durasert three-year treatment for posterior uveitis. The second Phase 3 study achieved its primary efficacy endpoint with high statistical significance (p<.001). The study involved 153 patients and the primary endpoint was the prevention of recurrence of posterior uveitis at six months with patients continuing to be followed for 36 months.
Durasert three-year insert demonstrated a significant reduction in recurrence of posterior segment uveitis through six months; 21.8 percent of Durasert treated patients had a recurrence compared to 53.8 percent of patients in the sham group. The results of the second Phase 3 study confirm the efficacy and safety profile of the Durasert insert demonstrated in the first Phase 3 study which also met its primary endpoint at six months (p<.001).
Data from the first Phase 3 study through 12 months of follow up were recently presented at the Association for Research in Vision and Ophthalmology (ARVO). The data at 12 months demonstrated the durability of the treatment effect; 27.6 percent of Durasert treated patients had a recurrence at 12 months compared to 85.7 percent of patients in the sham group.
pSivida has ongoing collaborations with other pharmaceutical companies to develop sustained-release products to treat retinal diseases and other ocular conditions. pSivida is also working with the Hospital for Special Surgery (HSS) to assess the efficacy of a titanium screw drug implant to treat pain associated with severe osteoarthritis of the knee.
Collaborating with the Future
pSivida has successfully created partnerships with some of the world’s leading pharmaceutical companies. pSivida seeks additional strategic partners to collaborate on the development of new sustained release drug devices; to access complementary research, technology, and development capabilities; and to expand our product portfolio.
pSivida technologies have broad applicability across therapeutic areas. “Our validated technologies can be utilized to deliver new drugs or to repurpose existing molecules in new applications,” says Lurker. pSivida’s intellectual property portfolio consists of its proven Durasert™ Technology platform for the delivery of small molecules.
Meet the Ace of pSivida
Nancy Lurker is the President and Chief Executive Officer of pSivida. She has broad-ranging experience in the pharmaceutical industry and companies serving the pharmaceutical industry, including diverse senior leadership positions. Prior to pSivida, she served as President, Chief Executive Officer, and a director of PDI, Inc., a NASDAQ-listed healthcare commercialization company. She successfully rebuilt PDI’s contract sales business, launching numerous pharmaceutical products for multiple companies across diverse therapeutic areas, including ophthalmology, in advance of a sale of that business line to Publicis Healthcare Communications Group. She also served as a member of Pharmacia’s U.S. executive management committee. Previously, Lurker spent 14 years at Bristol-Myers Squibb Company, rising from a sales representative to Senior Director, Worldwide Cardiovascular Franchise Management. Additionally, Lurker serves as a member of the Board of Directors of the privately held Cancer Treatment Centers of America. She is Chair of privately held X4 Pharmaceuticals. Lurker received a B.S. in Biology from Seattle Pacific University and an M.B.A. from the University of Evansville.
“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.”
“We are utilizing our Durasert bio-erodible technology platform in collaboration with other pharmaceutical companies to develop new sustained-release products to treat retinal diseases and other ocular conditions.”