Iluvien aids patients with diabetic macular edema, trial concludes

WATERTOWN, Mass. More than half the patients taking the low dose of a drug for diabetic macular edema were able to read at least five additional letters on a vision chart two years after beginning therapy with the drug, according to late-stage clinical results presented at the Angiogenesis 2010 meeting in Miami.

Data from FAME, a phase 3 study of pSivida Corp.’s drug Iluvien (fluocinolone acetonide) included efficacy and safety data in addition to results presented in December 2009 by pSivida and its licensee, Alimera Sciences. The study also showed that 28.7% of DME patients taking a low dose of the drug and 28.6% of those taking a high dose were able to see 15 additional letters, compared with 16.2% of those in the control group.

“We are very encouraged by the additional data presented at the Angiogenesis 2010 meeting and look forward to the upcoming NDA filing for potentially the first ophthalmic drug therapy approved for DME,” pSivida president and CEO Paul Ashton said in a statement.