Results of the prospective, randomized, controlled, multicenter phase 3 trials of the travoprost intraocular implant versus topical timolol

Abstract

Purpose : Two parallel Phase 3 pivotal trials (GC-010, GC-012) evaluated the safety and efficacy of a single administration of one of two travoprost intraocular implants (slow-eluting, fast-eluting) vs timolol in patients with open-angle glaucoma or ocular hypertension on 0-2 IOP-lowering medications. Data for the slow-eluting implant (iDose TR) are reported here.

Methods : The 2 multicenter, randomized, double-masked trials included a total of 383 slow-eluting travoprost intraocular implant patients (200 in GC-010, 183 in GC-012) and 386 timolol control patients (193 in GC-010, 193 in GC-012). The primary efficacy endpoint was non-inferiority to the active comparator, twice-daily topical timolol 0.5%, based on change from baseline in IOP at 8AM and 10AM at Day 10, Week 6 and Month 3. Safety was evaluated through Month 12, including adverse events and ophthalmic assessments.

Results : Over the first 3 months, mean IOP reductions from baseline for the travoprost implant groups were 6.6-8.5 mmHg and 6.7-8.4 mmHg in the GC-010 and GC-012 trials, respectively; and 6.6-7.7 mmHg and 6.8-7.2 mmHg for the timolol groups in the GC-010 and GC-012 trials, respectively. At Month 12, 93% of travoprost implant patients vs 67% of timolol patients were well-controlled on the same or fewer IOP-lowering topical medications compared to screening; and 81% of travoprost implant patients were free of topical IOP-lowering medications. Conjunctival hyperemia occurred in 3% of travoprost implant patients; no patients had clinically significant endothelial cell loss, periorbital fat atrophy, or serious corneal adverse events.

Conclusions : The travoprost implant achieved the pre-specified primary efficacy endpoint of non-inferiority to topical timolol, with a favorable safety profile and a high proportion of patients remaining topical IOP-lowering medication-free through Month 12.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.