A topical ophthalmic solution for diabetic macular edema (DME) met its preliminary safety and efficacy endpoints in a phase 1/2 study, according to a press release from SciFluor Life Sciences.
SF0166 is a novel small molecule drug that selectively inhibits integrin αvβ3. The drug has unique physiochemical properties that permit penetration to the retina in high concentrations after topical administration.
The trial enrolled 40 patients, randomized to 1 of 2 dose strengths (2.5% and 5.0%), who self-administered the eye drop twice daily. After 28 days of therapy, 53% of patients demonstrated a reduction in retinal thickness and improvements in visual acuity. The anatomic response was maintained for the month after treated was discontinued, demonstrating the drug’s durability.
There were no drug-related serious adverse events throughout the 28-day follow-up. Ocular adverse events were recorded in 6 patients and all were deemed mild in severity. No patient had significant loss of vision during treatment or follow-up, and none required rescue treatment with anti-VEGF injections.
“The safety and biological activity, clearly demonstrated in this first-in-patient study, supports continued clinical development of SF0166,” said David Boyer, MD, of the Retina-Vitreous Associates Medical Group in Los Angeles. “A safe and effective eye drop treatment for patients living with DME would be a major advance in the fight against this debilitating disease. A potential eye-drop treatment for DME may not only increase compliance, but also allow the opportunity to prevent vision loss by treating earlier in the disease pathway.”
Currently, there are no integrin inhibitors approved for macular disease. Allegro Ophthalmics recently reported positive phase 2 data for their first-in-class anti-integrin candidate ALG-1001 (Luminate) for DME. Luminate, however, is administered intravitreally.
SF0166 is also being studied in a separate multicenter phase 1/2 trial in patients with neovascular AMD.