Safety And Efficacy Of The Travoprost Intraocular Implant Compared To Topical Timolol In Two Phase 3 Registration Trials
Published 2023 - 41st Congress of the ESCRS
Reference: PO0872 | DOI: 10.82333/fwsc-2353
Authors: Lilit Albert Voskanyan* 1 , Steven Sarkisian 2 , Robert Ang 3 , Mark Gallardo 4 , John Berdahl 5 , Sebastian Heersink 6 , George Reiss 7 , Long Doan 8 , Kerry Stephens 8 , Robert Sanchez Jr. 8 , David Applegate 8 , Dale Usner 8 , Gabriella Szekely 8 , Angela Kothe 8 , L. Jay Katz 8 , Tomas Navratil 8
1Ophtalmological Center after S.V. Malayan,Yerevan,Armenia, 2Oklahoma Eye Surgeon's, PLLC,Oklahoma City,United States, 3Asian Eye Institute,Makati City,Philippines, 4El Paso Eye Surgeons,El Paso,United States, 5Vance Thompson Vision (SD),Sioux Falls,United States, 6Eye Center South dba Trinity Research Group,Dothan,United States, 7Eye Physicians and Surgeons of Arizona,Glendale,United States, 8Glaukos Corporation,Aliso Viejo,United States
Two Phase 3 registration trials (GC-010 and GC-012) evaluated the safety and IOP-lowering efficacy of a single administration of one of two models of travoprost intraocular implants (slow-eluting [iDose TR] and fast-eluting) compared to topical timolol maleate ophthalmic solution, 5 mg/mL administered twice daily in adult patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
The multicenter, randomized, double-masked, active-controlled trials were conducted at 44 study centers in the US and one in the Philippines (GC-010), and at 49 study centers in the US and one in Armenia (GC-012).
The trials enrolled patients on 0 to 2 IOP-lowering medications at screening. IOP entry criteria included a mean diurnal IOP of ≥ 21 mmHg and IOP ≤ 36 mmHg in the study eye at each timepoint (8AM, 10AM, and 4PM) after washout, if applicable. A total of 385 fast-eluting travoprost intraocular implant patients, 380 slow-eluting travoprost intraocular implant patients and 385 timolol control patients were randomized into the trials. The primary efficacy endpoint was non-inferiority to timolol 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.
Mean IOP reductions from baseline over the first 3 months with slow-eluting implant were 6.6 to 8.5 mmHg and 6.7 to 8.4 mmHg in GC-010 and GC-012, with results for fast-eluting implant of 6.6 to 8.4 mmHg and 6.2 to 8.3 mmHg. For the timolol groups, IOP reductions were 6.5 to 7.7 mmHg and 6.8 to 7.2 mmHg. At Month 12, 81% of slow-eluting implant patients did not require topical IOP-lowering medications, and 93% of slow-eluting implant patients versus 67% of timolol patients were well-controlled on the same or fewer topical IOP-lowering medications vs screening. Conjunctival hyperemia occurred in 3% of implant patients; no patients had clinically significant endothelial cell loss, periorbital fat atrophy, or serious corneal adverse events.
The slow-eluting travoprost intraocular implant was non-inferior to topical timolol in IOP-lowering efficacy, with a favorable safety profile and a high proportion of patients remaining well-controlled on the same or fewer IOP-lowering medications compared to screening.