The study is one of a continuing series evaluating Evizon (squalamine lactate) for the treatment of choroidal neovascularization associated with age-related macular degeneration (AMD), also known as “wet” AMD.
The interim safety results and visual acuity data are from up to nine weeks of treatment of Evizon with concomitant photodynamic therapy with verteporfin (PDT) (QLT Incorporated’s Visudyne) or PDT alone. The interim data show that Evizon with concomitant PDT was well tolerated in all subjects, with no drug-related serious adverse events reported to date.
At week nine, study eyes of subjects in the Evizon treatment groups gained an average of 1.3 ETDRS letters, while study eyes among subjects in the PDT control group lost an average of 0.9 EDTRS letters. In clinical trials evaluating therapies for wet AMD, gain or loss of less than 15 letters (three lines) for an individual patient on the ETDRS chart constitutes stable vision, while gain or loss equal to or greater than 15 letters constitutes a significant improvement or loss of vision, respectively.
“These early safety data demonstrate that Evizon can be given conveniently with PDT as a complementary, less-invasive treatment for early aggressive wet AMD lesions, where combined therapies are likely to be needed,” commented Dr Thomas Ciulla, of the Midwest Eye Institute, Indiana.
“While these data are preliminary and the next 20 weeks of the study will be critical in comparing outcomes, the results look encouraging and suggest that Evizon with concomitant PDT may represent a promising approach for managing this debilitating eye disease.”
Genaera is currently conducting three phase II trials of Evizon in wet AMD at multiple sites throughout the US.