Patient-reported Outcomes of Bimatoprost Ocular Ring in an Open-label Extension Study in Patients with Open-angle Glaucoma or Ocular Hypertension

Abstract

Purpose : The Bimatoprost Ocular Ring (BIM Ring) was developed as a non-invasive delivery system that rests on the ocular surface to address poor patient adherence to topical intraocular pressure (IOP) lowering medications. A multicenter, open-label extension (OLE) study was conducted to evaluate patient-reported comfort after long-term use of the BIM Ring in open-angle glaucoma or ocular hypertension.

Methods : This was a prospective, single arm safety study of patients who completed the initial randomized, double-masked Phase 2 study. Of 81 enrolled patients, 75 completed the study. Patients had at least 12 weeks of BIM Ring treatment in both eyes prior to entering the OLE. Two treatment cycles of 12 weeks and 26 weeks were included. New BIM Rings were placed in both eyes of all patients at the start of each treatment cycle. A questionnaire was administered to grade BIM Ring comfort level on a 5-point scale (0-Very Comfortable, 1-Comfortable, 2-Tolerable but Mild Discomfort, 3-Moderate Discomfort, 4- Severe Discomfort) and to provide patient preference in future use ofthe BIM Ring (-2-Strongly Prefer Eye Drops, -1-Slightly Prefer Eye Drops, 0-No Preference, 1-Slightly Prefer BIM Ring, 2-Strongly Prefer BIM Ring) throughout the study. Safety and efficacy were also evaluated.

Results : Mean comfort score of 0.63 (between Very Comfortable and Comfortable) at Week 12 was similar (0.62) at Week 24, 12 weeks after retreatment. Over 80% of patients reported the BIM Ring as comfortable (score 0 or 1) consistently throughout the study. Of the 35 who reported discomfort, most (21 patients) had no ocular adverse events (AE) associated with the discomfort; reports were intermittent and described as mild discomfort. Mean preference score was 0.49 at Week 12 and 0.54 at Week 24 showing a preference for BIM Ring over eye drops. Commonly reported AEs (>5%) after 50-week use of the BIM Ring were punctate keratitis (16.0%), eye discharge (14.8%), and ocular discomfort (6.2%). IOP reduction from baseline was 4.85±2.80 mmHg at Week 12 with a similar reduction from baseline of 4.55±3.35 mmHg at Week 24.

Conclusions : Most patients reported that the BIM Ring was comfortable and more patients preferred the BIM Ring over traditional eye drop therapy. The BIM Ring was shown to be well tolerated with an acceptable safety profile.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.