A topical ocular formulation of AKB-9778 given as an adjunctive therapy reduced IOP and was well tolerated in patients with ocular hypertension or primary open-angle glaucoma, according to a press release from Aerpio Pharmaceuticals.
Building on previous results of favorable tolerability and pharmacodynamic findings in ocular normotensive subjects, Aerpio recruited a cohort with OHT/POAG to assess the safety, tolerability and efficacy of once-daily AKB-9778, a Tie2-activating compound, as an adjunctive therapy to prostaglandin.
The phase 1b study consisted of 43 patients with IOP between 17 mm Hg and 27 mm Hg. Patients were randomly assigned to receive either 40 mg/mL AKB-9778 or placebo daily while continuing their use of prostaglandin therapy over 7 days.
Statistically significant decreases in IOP were recorded on day 7 in the study arm at 0, 4 and 8 hours after dosing compared with placebo (P = .007, P = .048 and P = .041, respectively).
“These early data suggest potential for a best in class profile for AKB-9778 to lower IOP when used in combination with prostaglandins,” Brian Levy, DO, MSc, said in the release. “Although this is a small study, we observed IOP reductions in the fifth cohort of this trial that are comparable to or better than those produced by common commercial adjunctive therapies used in conjunction with prostaglandins. Moreover, AKB-9778 was well-tolerated through 7 days of dosing with minimal hyperemia, no conjunctival hemorrhage and no discomfort on instillation.”