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G2-TR intraocular containing travoprost

Phase 3

Glaucoma, Open-Angle | Small molecule | Ophthalmology |Glaukos Corporation|Last Updated: Nov 29, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment1,150

FDA Designations

No designations recorded

Clinical trial landscape

G2-TR intraocular containing travoprost · 2 trials · 2 indications

Phase 3 2
NCT03868124Clinical Study Comparing Two Models of a Travoprost Intraocular ImplantGlaucoma, Open-Angle
COMPLETED560 Analytics
NCT03519386Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%Glaucoma, Open-Angle
COMPLETED590 Analytics
PHASE3COMPLETED
Clinical Study Comparing Two Models of a Travoprost Intraocular Implant
Glaucoma, Open-AngleUnlock trial analytics
PHASE3COMPLETED
Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
Glaucoma, Open-AngleUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative
3 Months

Change from time-matched baseline in IOP at 8AM and 10AM at Day 10, Week 6 and Month 3. Day 10 8AM IOP minus Baseline 8AM IOP; Day 10 10AM IOP minus Baseline 10AM IOP; Week 6 8AM IOP minus Baseline 8AM IOP; Week 6 10AM IOP minus Baseline 10AM IOP; Month 3 8AM IOP minus Baseline 8AM IOP; Month 3 10AM IOP minus Baseline 10AM IOP.

Secondary Endpoints

Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative
12 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Implant Group 1EXPERIMENTALG2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops.
Implant Group 2EXPERIMENTALG2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops.
Control GroupACTIVE_COMPARATORSham surgery + active-comparator eye drops

Interventions

NameTypeDescription
G2-TR intraocular implant containing travoprostCOMBINATION_PRODUCTProvided in Arm/Group descriptions
Sham surgery + active-comparator eye dropsDRUGSham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosed with open-angle glaucoma or ocular hypertension * C/D ratio ≤ 0.8 * Zero to two preoperative ocular hypotensive medications Exclusion Criteria: * Active corneal inflammation or edema * Retinal disorders not associated with glaucoma

Countries:United States
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Frequently asked questions about G2-TR intraocular containing travoprost

What is G2-TR intraocular containing travoprost used for?

G2-TR intraocular containing travoprost is an investigational small molecule being developed for the treatment of glaucoma and open-angle glaucoma. It is designed as an intraocular implant that delivers travoprost, a prostaglandin analog, to lower intraocular pressure in patients with these conditions.

Who makes G2-TR intraocular containing travoprost?

G2-TR intraocular containing travoprost is being developed by Glaukos Corporation, a company traded on the New York Stock Exchange under the ticker symbol GKOS. Glaukos specializes in ophthalmology and is advancing this product through clinical development for glaucoma and open-angle glaucoma.

What phase is G2-TR intraocular containing travoprost in?

G2-TR intraocular containing travoprost is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. Two Phase 3 trials have been completed, with a total enrollment of 1,150 patients, both conducted in the United States.

What clinical trials is G2-TR intraocular containing travoprost in?

G2-TR intraocular containing travoprost has completed two Phase 3 trials. NCT03519386 compared two models of the implant to timolol maleate ophthalmic solution 0.5% in 590 patients. NCT03868124 compared two models of the implant in 560 patients. Both trials enrolled adults with open-angle glaucoma or ocular hypertension.

How does G2-TR intraocular containing travoprost work?

G2-TR intraocular containing travoprost works by delivering travoprost, a prostaglandin analog, directly into the eye via an intraocular implant. Travoprost lowers intraocular pressure by increasing the outflow of aqueous humor, which helps manage glaucoma and open-angle glaucoma.

Is G2-TR intraocular containing travoprost the same as travoprost eye drops?

G2-TR intraocular containing travoprost is a sustained-release intraocular implant that contains travoprost, the same active ingredient found in travoprost eye drops. However, it is a different formulation and delivery method, designed to provide long-term pressure lowering with a single implant rather than daily eye drop administration.