BI-X, the first potential treatment for diabetic macular ischaemia (DMI), a complication of diabetic retinopathy (DR), was well tolerated in a recent Phase 1/2a trial.
The study’s single-rising-dose (SRD) phase demonstrated no dose-limiting events and no drug-related adverse events with intravitreal injection of BI-X in 12 DMI subjects. Across three dosing cohorts, the two higher-dose groups showed best-corrected visual acuity (BCVA) improvements compared with baseline. Three subjects in the lowest-dose cohort experienced subconjunctival haemorrhage and ocular hyperaemia.
Discovering a treatment for DMI is a major challenge, since it can lead to significant visual loss, even if the diabetic macular oedema is well controlled, said study lead Professor Quan Dong Nguyen, from Stanford University School of Medicine in the US. “It is our hope that BI-X can be among the first successful treatments for this devastating complication of diabetic retinopathy.”
