Canaloplasty Versus Trabecular Micro-Bypass Stent Implantation In Conjunction With Cataract Surgery In Primary Open Angle Glaucoma: 12-Month Interim Results Of The Venice Randomized Controlled Trial

To report the interim 12-month results from the ongoingVENICE study, a randomized controlled trial (RCT) comparing the safety and efficacy of STREAMLINE Surgical System (STRAMLINE) canaloplasty and iStent inject W (iStent W)implantation in mild to moderate primary open-angle glaucoma (POAG) eyes undergoing uncomplicated cataract extraction.

VENICE is an ongoing multicenter RCT in the United States and Latin America.

POAG eyes on 1-3 medications at Screening with post-washout Baseline IOP of 22-34 mmHg (inclusive) were randomized 1:1 to STREAMLINE canaloplasty or iStent W implantation following cataract surgery. Assessments included unmedicated mean diurnal intraocular pressure (MDIOP) at Baseline andpost-washout Month 12 (M12) visit, mean number of IOP-lowering medications at each visit, and the incidence of adverse events (AEs). Postoperative evaluations were performed at Day 1, Week 1, and Months 1, 3, 6, 9 and 12.

The first 72 eyes [STREAMLINE (n=35), iStent W (n=37)]were analyzed. Baseline MDIOP [(mmHg (SD)] werecomparable [STREAMLINE: 24.50 (3.02); iStent W: 25.00(3.23); p=0.465]. Both groups showed statistically significant reduction in M12 MDIOP compared to Baseline, P<.0001. M12MDIOP was 16.68 (3 .09) for STREAMLINE (n=31) and 16.81 (3.20) for iStent W (n=31). Mean medication counts (SD) at Screening was 1.90 (0.81) for STREAMLINE and 1.70 (0.90)for iStent W, p=0.531. At the pre-washout M12 visit, 87.1%(27/31) of STREAMLINE and 74.3% (26/35) of iStent W eyeswere medication-free. All (4/4) STREAMLINE and 5/9 iStent W medicated eyes were deemed safe for washout. Ocular AEs were mild, self-limited, and not related to device or procedure.

The ongoing VENICE RCT directly compares the safety and efficacy of STREAMLINE canaloplasty to iStent inject W implantation, in conjunction with cataract surgery. At Month 12, both STREAMLINE and iStent inject W demonstrated statistically significant reduction in IOP and IOP-lowering medications. More eyes in the STREAMLINE group were medication-free at Month 12 and all STREAMLINE eyes on medications were deemed safe to washout. Full cohort data will be reported in the future.