Topical treatment for DME tolerated in first-in-human trial

HONOLULU — Safety and tolerability objectives were met in a phase 1/2 first-in-human study of topical SF0166, a topical ophthalmic solution candidate for treatment of diabetic macular edema, a speaker said here.

“Safety and tolerability were excellent, and there was no evidence of corneal toxicity,” D. Scott Edwards, PhD, said at the Association for Research in Vision and Ophthalmology meeting.

Edwards presented data from a randomized, double-masked, multicenter study of 40 patients with DME randomized 1:1 in two arms to receive 1.25 mg or 2.5 mg SF0166 (SciFluor) twice a day for 28 days for both groups. SF0166 is a small molecule inhibitor of the integrin αvβ3, an endothelial cell surface receptor that modulates cellular response to VEGF.

Patients were assessed at five visits: start of treatment, day 14, end of treatment at day 28, an interim follow-up visit and an end of study visit. At each visit, adverse events were recorded, retinal thickness was measured by OCT, visual acuity was recorded, IOP was measured, and slit lamp and fundus exams were performed.

“Importantly, there were no drug-related serious adverse events,” Edwards said, adding that there were six non-drug-related non-ocular serious adverse events, all typically related to patients with diabetes.

There were seven ocular adverse events reported, but these were mild and only one was possibly related to treatment.

“Additionally, we looked for evidence of biological changes in OCT parameters,” Edwards said.

Biological activity was observed as a decrease in central retinal thickness as seen on spectral-domain OCT. Visual acuity changes were not correlated with those changes, however. – by Patricia Nale, ELS

Reference:

Edwards D. First-in-human study of SF0166 topical ophthalmic solution in patients with diabetic macular edema. Presented at: Association for Research in Vision and Ophthalmology annual meeting; April 28-May 3, 2018; Honolulu.

Disclosure: Edwards reports he is an employee of SciFluor, the sponsor of the study.