Safety and Exploratory Efficacy Study of SF0166 for the Treatment of Diabetic Macular Edema (DME)

This was a prospective, randomized, double-masked, multicenter, Phase I/II clinical study in which 44 eligible subjects with active Diabetic Macular Edema (DME) were randomized to 1 of 2 treatment arms in a 1:1 ratio as follows: SF0166 low dose twice daily (BID) or SF0166 high dose BID. Study subjects administered the randomly assigned treatment for 28 days. There was an additional 28-day post-treatment follow-up period. Study subjects returned for examination every 2 weeks for 8 weeks (2 months).