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Also known as Travoprost ophthalmic solution, 0.004% (new formulation), Travoprost, Travoprost ophthalmic solution (new formulation), Travoprost Ophthalmic Solution, 0.00013%, Travoprost, 0.00013%, Travoprost ophthalmic solution, 0.0008%, Travoprost, 0.0008%, Travoprost, Investigational
Travoprost, 0.004% · 12 trials · 5 indications
As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.
Travoprost free acid plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Cmax was calculated for each participant with at least 1 quantifiable time point.
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tmax was calculated for each participant with at least 1 quantifiable time point.
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tlast was calculated for each participant with at least 1 quantifiable time point.
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-tlast) was calculated for each participant with at least 2 quantifiable time points.
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-∞) was calculated for each participant with at least 3 quantifiable time points.
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). T½ was calculated for each participant with at least 3 quantifiable time points.
| Arm | Type | Description |
|---|---|---|
| Travoprost 0.003% | EXPERIMENTAL | Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months |
| TRAVATAN | ACTIVE_COMPARATOR | Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months |
| DuoTrav APS | EXPERIMENTAL | Travoprost/Timolol Maleate Fixed Combination solution, 1 drop in the study eye(s) once daily, at 9 AM, for 12 months |
| Travoprost/Timolol | EXPERIMENTAL | - |
| Dorzolamide/Timolol | ACTIVE_COMPARATOR | - |
| Travatan, Investigational | EXPERIMENTAL | - |
| Trav 0.00013% | EXPERIMENTAL | Travoprost Ophthalmic Solution, 0.00013%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
| Trav 0.00033% | EXPERIMENTAL | Travoprost Ophthalmic Solution, 0.00033%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
| Trav 0.001% | EXPERIMENTAL | Travoprost Ophthalmic Solution, 0.001%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
| Trav 0.00267% | EXPERIMENTAL | Travoprost Ophthalmic Solution, 0.00267%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
| Vehicle | PLACEBO_COMPARATOR | Travoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
| Travoprost new formulation | EXPERIMENTAL | Travoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks |
| Travoprost 0.0008% | EXPERIMENTAL | Travoprost ophthalmic solution, 0.0008%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks |
| Travoprost 0.001% | EXPERIMENTAL | Travoprost ophthalmic solution, 0.001%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks |
| Travoprost 0.0012% | EXPERIMENTAL | Travoprost ophthalmic solution, 0.0012%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks |
| TRAVATAN + Vehicle | ACTIVE_COMPARATOR | TRAVATAN, one drop in study eye(s) once daily (8 PM), and Vehicle, one drop in study eye(s) once daily (8 AM), for two weeks |
| Travoprost | EXPERIMENTAL | Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days |
| Name | Type | Description |
|---|---|---|
| Travoprost ophthalmic solution, 0.003% | DRUG | - |
| Travoprost ophthalmic solution, 0.004% | DRUG | - |
| Travoprost/Timolol Maleate Fixed Combination solution | DRUG | - |
| Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav) | DRUG | One drop in the study eye(s) once daily, 9 PM, for 6 weeks |
| Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt) | DRUG | One drop in the study eye(s) twice daily for 6 weeks |
| Timolol Vehicle | OTHER | One drop in the study eye(s) once daily for 6 weeks |
| Travoprost, Investigational | DRUG | One drop in study eye once daily for 13 days |
| Travoprost (TRAVATAN) | DRUG | One drop in study eye once daily for 13 days |
| Travoprost | DRUG | - |
| Latanoprost | DRUG | - |
| Travoprost (0.004%) | DRUG | - |
| Latanoprost (0.005%)/Timolol (0.5%) | DRUG | - |
| Latanoprost (0.005%) | DRUG | - |
| Travoprost Ophthalmic Solution, 0.00013% | DRUG | Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose |
| Travoprost Ophthalmic Solution, 0.00033% | DRUG | Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose |
| Travoprost Ophthalmic Solution, 0.001% | DRUG | Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose |
| Travoprost Ophthalmic Solution, 0.00267% | DRUG | Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose |
| Travoprost Vehicle | DRUG | Inactive ingredients used as an active comparator |
| Travoprost ophthalmic solution (new formulation) | DRUG | - |
| Vehicle | DRUG | Inactive ingredients used as a placebo |
| Travoprost ophthalmic solution, 0.0008% | DRUG | - |
| Travoprost ophthalmic solution, 0.0012% | DRUG | - |
| TRAVATAN | DRUG | - |
| Travoprost/brinzolamide | DRUG | - |
| Travoprost ophthalmic solution, 0.004% (new formulation) | DRUG | Travoprost ophthalmic solution, 0.004%, new formulation |
Inclusion Criteria: * Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension. * Qualifying intraocular pressure at both eligibility visits. * Understand and sign an informed consent form. * Other protocol-defined inclusio...
Top 4 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 5 | PHASE3 | Gen 2 Travoprost Intracameral, Travoprost |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | AGN-193408 |
| SpyGlass Pharma, Inc. | SGP | 4 | PHASE3 | Bimatoprost System |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE3 | Bimatoprost ophthalmic solution |
Travoprost ophthalmic solution, 0.004% is a small molecule eye drop developed by Alcon Inc. (ticker ALC) for glaucoma and ocular hypertension. It is studied in open-angle glaucoma, angle-closure glaucoma, and ocular hypertension. The program is in Phase 3 development, and the clinical trials supporting it have been completed.
Travoprost targets PTGFR, the prostaglandin F receptor, where it acts as an agonist. By activating this receptor, the drug is designed to influence aqueous humor dynamics in the eye. PTGFR agonism is the mechanism described for this ophthalmic small molecule in the glaucoma and ocular hypertension program.
Alcon Inc., which trades under the ticker ALC, is the developer of travoprost ophthalmic solution, 0.004%. Alcon is the company behind the travoprost program across its studied glaucoma and ocular hypertension indications. The asset is a small molecule ophthalmology candidate in the company's eye care portfolio.
Travoprost ophthalmic solution, 0.004% is in Phase 3 development. It is an investigational asset, and the program's registered trials are all completed, with no active trials at this time. Six trials in total have been conducted, enrolling 1,704 participants overall.
Registered trials include NCT01453855, a Phase 3 safety and efficacy study in open-angle glaucoma and ocular hypertension with 1,099 participants, and NCT00928590, a Phase 3 safety study of DuoTrav APS in the same conditions. Earlier work includes NCT01298687, a Phase 2 divided-dose study, and NCT01658839, a Phase 1 pediatric pharmacokinetic and safety study.
Yes. Travoprost ophthalmic solution, 0.004% is also known as travoprost, and related names include travoprost ophthalmic solution (new formulation), travoprost/brinzolamide, and the travoprost/timolol fixed combination, including DuoTrav. These names refer to the same travoprost program developed by Alcon for glaucoma and ocular hypertension.