A clinical trial study, entitled “Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Neovascular Age-Related Macular Degeneration (AMD)”, has reported topline results indicating safety and tolerability for a new topical formulation for the treatment of wet AMD. An eye-drop therapeutic capable of penetrating tissues at the back of the eye would represent a significant advance if comparable in outcome measures to current anti-VEGF treatments.
The study, a prospective, randomized, double-masked, multicenter, Phase I/II trial of 44 eligible subjects with neovascular AMD, randomized patients to one of two treatment arms in a 1:1 ratio of 2.5% SF0166 or 5.0% SF0166. The exclusively US study population, recruited across 12 centres, included male and female subjects aged 50 years or older. Study subjects self-administered the randomly assigned eye-drop treatment for 28 days, with an additional 28-day post-treatment follow-up period. Of the recruited subjects, 42 evaluable patients were assessed with the study co-rodinator reporting that the primary outcome measure of safety was “clearly achieved with no drug-related serious adverse events observed in the study throughout the 28-day course of treatment as well as during the 28-day follow-up period.”
According to the sponsor of the study, SciFlour Life Sciences Inc., of Cambridge, Massachusetts, the experimental treatment demonstrated “clinically significant biological activity, as assessed by a panel of three leading retinal physicians, in 9 of the 42 patients”, representing 21% of the patient participants. No primary data was released by the sponsor. Jeffrey S. Heier, MD, Ophthalmic Consultants of Boston commented on the preliminary results stating that, “SF0166 was very well-tolerated in this phase 1/2 study, and the demonstration of biological activity seen in patients in this heterogeneous population of wet-AMD patients despite the short study duration was encouraging for a topical treatment.” Supporting the data reported in a topline format, SciFluor’s Chief Executive Officer, Omar Amirana, M.D., commented that, “[c]ombined with our previously reported data in diabetic macular edema patients, we now have an impressive safety profile for SF0166 in over 80 patients coupled with distinct evidence of biological activity for both indications. This implies that the drug is not only well-tolerated but that it is reaching the back of the eye and is active. These exciting results highlight the prospect that wet-AMD and DME patients could be treated with an eye drop that penetrates to the back of the eye. If approved, an eye drop therapy could encourage earlier treatment in the course of the disease which has the potential to improve outcomes, while offering obvious patient benefits versus current injectable alternatives.”