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 (ranibizumab injection, Genentech) treatments.
Performed under an investigator sponsored IND, the study will compare two doses of Medidur FA (0.2 and 0.5ug/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.
Paul Ashton, managing director of pSivida, said: “The approval of Medidur to treat exudative age-related macular degeneration (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.”