THR-317 for the treatment of diabetic macular edema met its primary safety endpoint in a phase 1/2 study and also demonstrated efficacy, according to a press release from Oxurion.
Anat Loewenstein, MD , MHA, professor of ophthalmology, chair of the ophthalmology division at Tel Aviv Medical Center, presented the clinical-stage data at FLORetina 2019. Two dose levels, 4 mg and 8 mg, of the anti-placental growth factor candidate THR-317 were evaluated for safety and efficacy in 49 patients with DME, including anti-VEGF-naive patients and suboptimal anti-VEGF responders.
Both groups met the primary endpoint for safety, but patients who received the 8-mg dose achieved better visual acuity outcomes compared with the 4-mg dose group.
At day 90 of the study, 30 days after the last injection, topline data demonstrated THR-317 was safe and well tolerated. Thirty percent of anti-VEGF-naive patients achieved a 15-letter vision gain in best corrected visual acuity. At day 150, 30% of patients in the 8-mg anti-VEGF-naive group achieved a 10 letter or greater vision gain and 10% achieved a 15 letter or greater vision gain.