Topline Results From Prospective, Double-masked, Placebo Controlled Phase 2 Clinical Study Evaluating Luminate^® (ALG-1001) in Patients with Symptomatic Focal Vitreomacular Adhesion

Abstract

Purpose : To investigate the safety and efficacy of Luminate (ALG-1001), a synthetic anti-angiogenic and vitreolytic oligopeptide, administered intravitreally in patients with focal vitreomacular adhesion (VMA) or vitreomacular traction (VMT).

Methods : Patients were randomly assigned to four groups. Group 1 received intravitreal Luminate 2.0 mg, Group 2 received Luminate 2.5 mg, Group 3 received Luminate 3.2 mg, and Group 4 (control) received an intravitreal injection of balanced salt solution. Intravitreal injections were administered monthly until VMA or VMT release was achieved for a total of 90 days with three maximum injections. VMA or VMT release was determined by optical coherence tomography (OCT) images read by Duke Reading Center. The primary endpoint of this study was observation of pharmacologic resolution of VMA by OCT, with VMA defined as vitreous adhesion to the macula within a 6mm central retinal field determined on OCT.

Results : One hundred and six patients from approximately 20 sites in the United States and Europe were included in this analysis. Sixty-five percent of patients treated with the 3.2 mg dose of Luminate achieved release of VMA or VMT by Day 90 (p=0.0129), compared to 21% of those in the 2.5 mg group, 23% in the 2.0 mg group, and 10% of those in the placebo control group. For all groups, 48% of all releases occurred after the first injection, 32% occurred after the second injection, and 20% of all releases occurred after the third injection. The most commonly reported AEs were conjunctival hyperemia and sub-conjunctival hemorrhage at the injection site. There was no incidence of drug toxicity or significant intraocular inflammation, no afferent pupillary defects, and no evidence of retinal tears or detachments among all groups.

Conclusions : Data from this phase 2 VMA/VMT trial demonstrated that Luminate met its primary endpoint of VMA or VMT release. Luminate was well-tolerated in all Luminate dosing groups.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.