A single, 1.0 or 2.0 mg intravitreal injection of the designed ankyrin repeat protein (DARPin) MP0112 showed promising efficacy and long-term duration in a trial of patients with age-related macular degeneration (AMD).
A single, 1.0 or 2.0 mg intravitreal injection of the designed ankyrin repeat protein (DARPin) MP0112 showed promising efficacy and long-term duration in a trial of patients with age-related macular degeneration (AMD), resulting in mean decreases in retinal thickness and leakage area, according to an article published online in the American Journal of Ophthalmology.
MP0112 is an experimental treatment for exudative AMD. It binds with high affinity to vascular endothelial growth factor-A (VEGF-A).
Researchers from France, Switzerland and the Czech Republic (the MP0122 Study Group) conducted a Phase I/II, open-label, dose-escalation study of 32 treatment-naïve AMD patients. The patients were to receive a single intravitreal injection of MP0112 at doses ranging from 0.04 to 3.6 mg, and then monitored for 16 weeks.
Following injection, visual acuity scores were stable or improved compared with baseline for at least 4 weeks, and retinal thickness and leakage on fluorescein angiography decreased in a dose-dependent manner.
Thirteen of the 32 patients (41%) reported drug-related adverse events, 11 of which were ocular inflammation (7 mild, 4 moderate). Twenty of the 22 patients (91%) who received 0.04 to 0.4 mg MP0112 required rescue therapy, compared with 4 of 10 patients who received 1.0 or 2.0 mg. Five of the six patients (83%) in the higher-dose cohorts who did not require rescue treatment maintained reductions in central retinal thickness for the 16-week duration of the study.
The researchers concluded that the maximum tolerated dose was 1.0 mg because of a case of endophthalmitis that occurred in the 2.0 mg cohort.
"The prolonged duration of action observed… in this trial indicates the possibility of extending the duration of effect by prolonging suppression of VEGF. Larger clinical trials, with the new purified investigational product, are needed to confirm these findings and quantify the effect of the drug," the researchers wrote.
To access the full study, click here.