Posters

Results of Phase 3 Study of Bimatoprost SR’s IOP Lowering in Patients with Prior Treatments: PGA and SLT

Poster Details

First Author: F.Cordeiro UK

Co Author(s):    M. Bejanian   M. Robinson   K. Wang   M. Kolko   K. Lim   L. Rossetti     

Abstract Details

Purpose:

To evaluate the efficacy of the intracameral, sustained-release bimatoprost implant (Bimatoprost SR, BimSR) on intraocular pressure (IOP) lowering in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) who were previously treated with a topical prostaglandin/prostamide analog (PGA; specifically, bimatoprost, latanoprost, tafluprost, travoprost) or selective laser trabeculoplasty (SLT).

Setting:

A total of 108 and 113 sites (14 and 15 countries, respectively) randomized patients 1:1:1 to BimSR 10 µg (BimSR 10µg), 15µg (BimSR 15µg), or topical timolol 0.5% BID (timolol) and treated them per identical protocols in phase 3 ARTEMIS 1 (NCT02247804) and ARTEMIS 2 (NCT02250651) studies.

Methods:

In these two identical, double-masked, prospective, 20-month, phase 3 studies (N=594 and 528), patients with OAG or OHT received study eye treatment with BimSR 10μg, BimSR 15μg, or timolol. Patients with prior SLT could be included if SLT was performed greater than 6 months before screening. All previous IOP-lowering medications were washed out before baseline. Primary endpoint was IOP lowering through 12 weeks. Analysis of study eye IOP change from baseline (CFB) used interim pooled data from the 12-week database lock for patients with prior SLT or PGA treatment in the study eye.

Results:

Mean baseline IOPs were similar across BimSR 10µg, BimSR 15µg, and timolol subgroups (n=346, 343, 352 without prior SLT; n=28, 31, 22 with prior SLT; n=135, 144, 131 without prior PGAs; n=239, 230, 243 with prior PGAs, respectively). Week 12 mean ± SD IOP CFB in the BimSR 10µg, BimSR 15µg, and timolol groups, respectively, was −6.97±3.82, −7.30±3.89, and −6.90±3.90 mmHg in patients without prior SLT; −7.00±3.62, −6.07±4.40, and −5.76±4.27 mmHg in patients with prior SLT; −6.96±3.59, −7.16±3.87, and −6.72±3.73 mmHg in patients without prior PGA; and −6.98±3.92, −7.22±4.00, and −6.89±4.03 mmHg in patients with prior PGA.

Conclusions:

BimSR lowered IOP effectively across all subgroups, regardless of prior treatment with SLT or topical PGA, indicating that prior treatment does not affect the efficacy of BimSR.

Financial Disclosure:

is employed by a for-profit company with an interest in the subject of the presentation, research is funded, fully or partially, by a competing company, receives consulting fees, retainer, or contract payments from a competing company, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented