May 9 2008
pSivida Limited announced today that enrolment has begun for a clinical trial to assess the safety and efficacy of Medidur™ FA in conjunction with Lucentis® (ranibizumab injection, Genentech) in patients with exudative age-related macular degeneration (wet AMD). The study is designed to provide preliminary information on the potential of Medidur FA to maintain the efficacy established with Lucentis while reducing the overall number of Lucentis treatments.
Performed under an investigator sponsored IND, the study will compare two doses of Medidur FA (0.2 and 0.5 ug/day) in patients that have been treated with Lucentis for at least six months. The change from baseline in parameters such as visual acuity and retinal thickness will be assessed, and the number of Lucentis injections required pre and post-treatment will be compared.
“The approval of Medidur to treat Wet AMD could dramatically increase the market potential for Medidur FA. Under our revised agreement with Alimera Sciences, Alimera is responsible for funding all Medidur FA development costs,” said Dr. Paul Ashton, Managing Director of pSivida.
- Medidur FA is a tiny injectable intravitreal device designed to release fluocinolone acetonide to the retina for up to three years. It is presently in a fully enrolled Phase III clinical trial for the treatment of Diabetic Macular Edema (DME).
- Wet AMD is the leading cause of vision loss in people over 65 in the developed world and is characterized by the formation of leaky new blood vessels originating in the choroid which may haemorrhage and cause accumulation of sub- and intraretinal fluid.
- Lucentis is approved for the treatment of wet AMD and requires repeated injections directly into the eye to maintain efficacy.