PMID- 38423216
OWN - NLM
STAT- MEDLINE
DCOM- 20240822
LR  - 20250102
IS  - 1549-4713 (Electronic)
IS  - 0161-6420 (Linking)
VI  - 131
IP  - 9
DP  - 2024 Sep
TI  - Phase 3 Randomized Clinical Trial of the Safety and Efficacy of Travoprost 
      Intraocular Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension.
PG  - 1021-1032
LID - S0161-6420(24)00161-1 [pii]
LID - 10.1016/j.ophtha.2024.02.022 [doi]
AB  - PURPOSE: To evaluate the safety and intraocular pressure (IOP)-lowering efficacy 
      of 2 models of the travoprost intraocular implant (fast-eluting [FE] and 
      slow-eluting [SE] types) from 1 of 2 phase 3 trials (the GC-010 trial). DESIGN: 
      Multicenter, randomized, double-masked, sham-controlled, noninferiority trial. 
      PARTICIPANTS: Patients with open-angle glaucoma or ocular hypertension having an 
      unmedicated baseline mean diurnal IOP (average of 8 am, 10 am, and 4 pm time 
      points) of >/= 21 mmHg, and IOP of </= 36 mmHg at each of the 8 am, 10 am, and 4 pm 
      timepoints at baseline. METHODS: Study eyes were randomized to the travoprost 
      intraocular implant (FE implant [n = 200] or SE implant [n = 197] model) or to 
      timolol ophthalmic solution 0.5% twice daily (n = 193). MAIN OUTCOME MEASURES: 
      The primary outcome was mean change from baseline IOP in the study eye at 8 am 
      and 10 am, at each of day 10, week 6, and month 3. Safety outcomes included 
      adverse events (AEs) and ophthalmic assessments. RESULTS: Mean IOP reduction from 
      baseline over the 6 time points 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 end point 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 time points. Study eye AEs, most of mild or 
      moderate severity, were reported in 21.5%, 27.2%, and 10.8% of patients 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 hyperemia (FE 
      implant, 3.0%; SE implant, 2.6%), reduced visual acuity (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%). One serious study eye AE occurred (endophthalmitis). 
      CONCLUSIONS: The travoprost intraocular implant demonstrated robust IOP reduction 
      over the 3-month primary efficacy evaluation period after a single 
      administration. The IOP-lowering efficacy in both implant groups was 
      statistically and clinically noninferior to that in the timolol group, with a 
      favorable safety profile. FINANCIAL DISCLOSURE(S): Proprietary or commercial 
      disclosure may be found in the Footnotes and Disclosures at the end of this 
      article.
CI  - Copyright (c) 2024. Published by Elsevier Inc.
FAU - Sarkisian, Steven R Jr
AU  - Sarkisian SR Jr
AD  - Oklahoma Eye Surgeons, PLLC, Oklahoma City, Oklahoma.
FAU - Ang, Robert E
AU  - Ang RE
AD  - Asian Eye Institute, Makati City, Philippines.
FAU - Lee, Andy M
AU  - Lee AM
AD  - Total Eye Care, Duncanville, Texas.
FAU - Berdahl, John P
AU  - Berdahl JP
AD  - Vance Thompson Vision, Sioux Falls, South Dakota.
FAU - Heersink, Sebastian B
AU  - Heersink SB
AD  - Eye Center South, DBA Trinity Research Group, Dothan, Alabama.
FAU - Burden, James H
AU  - Burden JH
AD  - Skyline Vision Clinic and Laser Center, Colorado Springs, Colorado.
FAU - Doan, Long V
AU  - Doan LV
AD  - Glaukos Corporation, Aliso Viejo, California.
FAU - Stephens, Kerry G
AU  - Stephens KG
AD  - Glaukos Corporation, Aliso Viejo, California.
FAU - Kothe, Angela C
AU  - Kothe AC
AD  - Glaukos Corporation, Aliso Viejo, California.
FAU - Usner, Dale W
AU  - Usner DW
AD  - Glaukos Corporation, Aliso Viejo, California.
FAU - Katz, L Jay
AU  - Katz LJ
AD  - Glaukos Corporation, Aliso Viejo, California.
FAU - Navratil, Tomas
AU  - Navratil T
AD  - Glaukos Corporation, Aliso Viejo, California. Electronic address: 
      tnavratil@glaukos.com.
CN  - GC-010 Travoprost Intraocular Implant Investigators
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20240227
PL  - United States
TA  - Ophthalmology
JT  - Ophthalmology
JID - 7802443
RN  - WJ68R08KX9 (Travoprost)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Drug Implants)
RN  - 817W3C6175 (Timolol)
RN  - 0 (Ophthalmic Solutions)
SB  - IM
MH  - Humans
MH  - *Glaucoma, Open-Angle/drug therapy/physiopathology
MH  - *Intraocular Pressure/drug effects/physiology
MH  - *Ocular Hypertension/drug therapy/physiopathology
MH  - *Travoprost/therapeutic use/administration & dosage
MH  - *Antihypertensive Agents/administration & dosage/therapeutic use/adverse effects
MH  - Female
MH  - Male
MH  - Double-Blind Method
MH  - Aged
MH  - Middle Aged
MH  - *Drug Implants
MH  - *Tonometry, Ocular
MH  - Treatment Outcome
MH  - Visual Acuity/physiology
MH  - Timolol/administration & dosage/therapeutic use/adverse effects
MH  - Ophthalmic Solutions
MH  - Aged, 80 and over
MH  - Adult
OTO - NOTNLM
OT  - Drug delivery system
OT  - Intracameral implant
OT  - Intraocular pressure
OT  - Prostaglandin analog
OT  - Travoprost intraocular implant
FIR - Ang, Robert E
IR  - Ang RE
FIR - Heersink, Sebastian B
IR  - Heersink SB
FIR - Vold, Steven
IR  - Vold S
FIR - Atodaria, Neil
IR  - Atodaria N
FIR - Brubaker, Jacob
IR  - Brubaker J
FIR - Goldberg, Damien
IR  - Goldberg D
FIR - Lin, Christopher
IR  - Lin C
FIR - Nguyen, Betsy
IR  - Nguyen B
FIR - Schultz, Mitchell
IR  - Schultz M
FIR - Silverstein, Bruce
IR  - Silverstein B
FIR - Sorenson, Robert
IR  - Sorenson R
FIR - Bashford, Kent
IR  - Bashford K
FIR - Burden, James H
IR  - Burden JH
FIR - ElMallah, Mohammed
IR  - ElMallah M
FIR - Kim, Joshua
IR  - Kim J
FIR - Lambright, Benjamin
IR  - Lambright B
FIR - McCabe, Cathleen
IR  - McCabe C
FIR - Shetty, Rajesh
IR  - Shetty R
FIR - Smith, Steven
IR  - Smith S
FIR - Tyson, Farrell
IR  - Tyson F
FIR - Jones, Jason
IR  - Jones J
FIR - D'Ambrosio, Francis
IR  - D'Ambrosio F
FIR - Wu, Bin
IR  - Wu B
FIR - Basha, Mahdi
IR  - Basha M
FIR - Chu, Ralph
IR  - Chu R
FIR - Gira, Joseph
IR  - Gira J
FIR - Swan, Russell
IR  - Swan R
FIR - Baartman, Brandon
IR  - Baartman B
FIR - Wellish, Kent
IR  - Wellish K
EDAT- 2024/03/01 01:22
MHDA- 2024/08/23 00:43
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- 2024/08/23 00:43 [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 - ppublish
SO  - Ophthalmology. 2024 Sep;131(9):1021-1032. doi: 10.1016/j.ophtha.2024.02.022. Epub 
      2024 Feb 27.