SciFluor Life Sciences announced positive topline results of a phase 1/2 trial studying the treatment of wet age-related macular degeneration (AMD) patients with SF0166, the company’s lead eye drop drug for back of the eye diseases. The double masked phase 1/2 study assessed the safety, tolerability and preliminary efficacy of SF0166 in 42 evaluable subjects with neovascular (wet) AMD who were randomized 1:1 to self-administer an eye drop containing either a 2.5% or a 5% solution of SF0166 twice-a-day for 28 days.
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. Ocular adverse events were recorded in the treated eyes of 5 patients; all events were mild or moderate in severity, with one considered possibly drug-related.
SF0166 also demonstrated clinically significant biological activity, as assessed by a panel of three leading retinal physicians, in 9 of the 42 patients who completed the study evidenced by decreases in central retinal thickness and/or subretinal fluid by spectral domain optical coherence tomography. The mean improvement in visual acuity during the treatment period among the treatment naïve group was approximately 5 letters.
“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,” Jeffrey S. Heier, MD, Ophthalmic Consultants of Boston, said in a company news release. “I look forward to the continued clinical advancement of SF0166.”
“Combined 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,” said Omar Amirana, MD, SciFluor’s Chief Executive Officer and Senior Vice President at Allied Minds. “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.”
About the Phase 1/2 Clinical Trial
The phase 1/2 study assessed the safety and preliminary efficacy of SF0166 in 42 evaluable wet-AMD patients who were randomized 1:1 to either a 2.5% or a 5% solution of SF0166 self-administered as an eye drop twice-a-day for 28 days.
The patients were further assessed over an additional 28-day follow-up period off SF0166. The study was conducted at 8 sites in the US (clinicaltrials.gov ID#: NCT02914639) and included treatment-naïve patients as well as patients with prior anti-VEGF treatment.