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SciFluor’s DME drop treatment shows positive early study results
A topical ophthalmic solution for diabetic macular edema showed positive results in a phase 1/2 trial, according to a press release from SciFluor Life Sciences.
SF0166, a selective small molecule inhibitor of integrin alpha V beta 3, was studied in 40 patients with DME who were randomly assigned to one of two dose strengths, 2.5% and 5%, twice a day for 28 days.
Safety was the primary outcome measure of the study. No drug-related serious adverse events occurred during the treatment or the 28-day follow-up period. Six patients experienced ocular adverse events in their treated eyes, but all were considered mild in severity. One of these cases was possibly drug-related.
Biological activity was demonstrated in both patient groups, with 53% of the patients showing a reduction in retinal thickness and improvement in visual acuity, the release said.
Perspective
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SciFluor is developing a twice-a-day self-administered topical drop, SF0166, for use in retinal diseases like DME and wet age-related macular degeneration. SF0166 is a small molecule integrin inhibitor that selectively inhibits integrin alpha V beta 3. The company recently announced that in their initial phase 1/2 trial of eyes with DME (N = 40, 28-day trial), both safety and biological activity were demonstrated. There are currently no integrin inhibitors approved for macular disease; however, Allegro Ophthalmics recently reported positive phase 2 data for their intravitreal integrin inhibitor ALG-1001 (Luminate) in DME. In addition, Shire’s lifitegrast is a topical integrin antagonist recently FDA approved for dry eye disease. Topical delivery of therapeutics to the back of the eye is challenging. Other than corticosteroids, no other pharmaceutical class has shown efficacy with an acceptable safety profile. In addition, given the high degree of effectiveness of anti-VEGF intravitreal therapy, the pathway to FDA approval in DME for a novel pathway inhibitor, either as stand-alone therapy or in conjunction with anti-VEGFs, regardless of delivery system, is daunting. Despite these hurdles, an alternative to intravitreal delivery and a new pathway to combat retinal disease are both very attractive features of SciFluor’s SF0166.