PMID- 38423216
OWN - NLM
STAT- Publisher
LR  - 20240229
IS  - 1549-4713 (Electronic)
IS  - 0161-6420 (Linking)
DP  - 2024 Feb 27
TI  - Phase 3 Randomized Clinical Trial of the Safety and Efficacy of Travoprost 
      Intraocular Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension.
LID - S0161-6420(24)00161-1 [pii]
LID - 10.1016/j.ophtha.2024.02.022 [doi]
AB  - PURPOSE: Evaluate the safety and intraocular pressure (IOP)-lowering efficacy of 
      two models of the travoprost intraocular implant (fast-eluting [FE-implant] and 
      slow eluting [SE-implant]) from one of two pivotal trials (GC-010). DESIGN: Phase 
      3, multicenter, randomized, double-masked, sham-controlled, non-inferiority 
      trial. PARTICIPANTS: Subjects with open-angle glaucoma or ocular hypertension, 
      using 0 to 3 IOP-lowering medications at screening and having an unmedicated 
      baseline mean diurnal IOP (average of 8AM, 10AM and 4PM timepoints) of >/= 21 mmHg, 
      and an unmedicated baseline IOP of </= 36 mmHg at each timepoint in the study eye. 
      METHODS: Study eyes were randomized to the travoprost intraocular implant 
      (FE-implant [n=200] or SE-implant [n=197] model) plus twice-daily (BID) placebo 
      eye drops, or to sham procedure plus timolol ophthalmic solution, 0.5% BID 
      (n=193). MAIN OUTCOME MEASURES: The primary outcome was mean change from baseline 
      IOP in the study eye at 8AM and 10AM, at each of day 10, week 6, and month 3. 
      Safety outcomes included adverse events (AEs), corneal endothelial cell counts, 
      visual acuity, and conjunctival hyperemia assessment. RESULTS: Mean IOP reduction 
      from baseline over the 6 timepoints ranged from 6.6 to 8.4 mmHg for the 
      FE-implant group, from 6.6 to 8.5 mmHg for the SE-implant group, and from 6.5 to 
      7.7 mmHg for the timolol group. The primary efficacy endpoint was met; the upper 
      limit of the 95% confidence interval of the difference between the implant groups 
      and the timolol group was < 1 mmHg at all 6 timepoints. Study eye AEs, most of 
      mild or moderate severity, were reported in 21.5%, 27.2% and 10.8% of subjects in 
      the FE-implant, SE-implant and timolol groups, respectively. The most common AEs 
      included iritis (FE-implant, 0.5%; SE-implant, 5.1%), ocular hyperaemia 
      (FE-implant, 3.0%; SE-implant, 2.6%), visual acuity reduced (FE-implant, 1.0%; 
      SE-implant, 4.1%; timolol, 0.5%), and IOP increased (FE-implant, 3.5%; 
      SE-implant, 2.6%; timolol, 2.1%). There was one serious study eye AE 
      (endophthalmitis). CONCLUSIONS: The travoprost intraocular implant demonstrated 
      robust IOP reduction over the 3-month primary efficacy evaluation period 
      following a single administration. The IOP-lowering efficacy of both implant 
      groups was statistically and clinically non-inferior to the timolol group, with a 
      favorable safety profile.
CI  - Copyright (c) 2024. Published by Elsevier Inc.
FAU - Sarkisian, Steven R Jr
AU  - Sarkisian SR Jr
AD  - Oklahoma Eye Surgeons, PLLC, 5600 N Portland Avenue, Oklahoma City, OK, 73112.
FAU - Ang, Robert E
AU  - Ang RE
AD  - Asian Eye Institute, 8th to 10th Floor, Rockwell Center, PHINMA Plaza Building, 
      Makati City, 01200 Philippines.
FAU - Lee, Andy M
AU  - Lee AM
AD  - Total Eye Care, 388 E. Hwy 67, Duncanville, TX 75137.
FAU - Berdahl, John P
AU  - Berdahl JP
AD  - Vance Thompson Vision, 3101 West 57th Street, Sioux Falls, SD 57108.
FAU - Heersink, Sebastian B
AU  - Heersink SB
AD  - Eye Center South, DBA Trinity Research Group, 2800 Ross Clark Circle, Dothan, AL 
      36301.
FAU - Burden, James H
AU  - Burden JH
AD  - Skyline Vision Clinic and Laser Center, 3155 North Union Boulevard, Colorado 
      Springs, CO 80907.
FAU - Doan, Long V
AU  - Doan LV
AD  - Glaukos Corporation, One Glaukos Way, Aliso Viejo, CA 92656.
FAU - Stephens, Kerry G
AU  - Stephens KG
AD  - Glaukos Corporation, One Glaukos Way, Aliso Viejo, CA 92656.
FAU - Kothe, Angela C
AU  - Kothe AC
AD  - Glaukos Corporation, One Glaukos Way, Aliso Viejo, CA 92656.
FAU - Usner, Dale W
AU  - Usner DW
AD  - Glaukos Corporation, One Glaukos Way, Aliso Viejo, CA 92656.
FAU - Katz, L Jay
AU  - Katz LJ
AD  - Glaukos Corporation, One Glaukos Way, Aliso Viejo, CA 92656.
FAU - Navratil, Tomas
AU  - Navratil T
AD  - Glaukos Corporation, One Glaukos Way, Aliso Viejo, CA 92656. Electronic address: 
      tnavratil@glaukos.com.
CN  - GC-010 Travoprost Intraocular Implant Investigators
LA  - eng
PT  - Journal Article
DEP - 20240227
PL  - United States
TA  - Ophthalmology
JT  - Ophthalmology
JID - 7802443
SB  - IM
EDAT- 2024/03/01 01:22
MHDA- 2024/03/01 01:22
CRDT- 2024/02/29 19:15
PHST- 2023/09/27 00:00 [received]
PHST- 2024/02/14 00:00 [revised]
PHST- 2024/02/20 00:00 [accepted]
PHST- 2024/03/01 01:22 [medline]
PHST- 2024/03/01 01:22 [pubmed]
PHST- 2024/02/29 19:15 [entrez]
AID - S0161-6420(24)00161-1 [pii]
AID - 10.1016/j.ophtha.2024.02.022 [doi]
PST - aheadofprint
SO  - Ophthalmology. 2024 Feb 27:S0161-6420(24)00161-1. doi: 
      10.1016/j.ophtha.2024.02.022.