Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Travoprost ophthalmic solution, 0.004% (new formulation), Travoprost (Groups A, B and C), Travoprost, Travoprost ophthalmic solution (new formulation), Travoprost Ophthalmic Solution, 0.00013%, Travoprost, 0.00013%, Travoprost ophthalmic solution, 0.0008%, Travoprost, 0.0008%
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 5 | PHASE3 | Gen 2 Travoprost Intracameral, Timolol eye 0.5% |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Undisclosed |
| SpyGlass Pharma, Inc. | SGP | 4 | PHASE3 | Bimatoprost System, Timolol, 0.5% |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE3 | Test- Bimatoprost 0.01%, Reference- LUMIGAN |
| Alcon AG | ALC | 5 | N/A | Undisclosed |
| Sight Sciences, Inc. | SGHT | 3 | N/A | Undisclosed |
Travoprost is used for lowering elevated intraocular pressure in patients with open-angle glaucoma, angle-closure glaucoma, or ocular hypertension. It is a small molecule developed by Alcon Inc. for the ophthalmology therapeutic area and is currently in Phase 3 clinical development.
Travoprost is a prostaglandin analog that works by increasing the outflow of aqueous humor from the eye, thereby reducing intraocular pressure. It is used in the treatment of glaucoma and ocular hypertension.
Travoprost is developed by Alcon Inc., a company traded under the ticker symbol ALC. Alcon is conducting clinical trials to evaluate the drug's safety and efficacy in patients with glaucoma and ocular hypertension.
Travoprost is in Phase 3 clinical development. It has completed five trials, including Phase 2 and Phase 3 studies, with a total enrollment of 1,549 participants. The drug is investigational and not yet approved by regulatory authorities.
Travoprost has been studied in several completed clinical trials, including NCT00293761 (Phase 3), NCT00527501 (Phase 2), NCT00637130 (Phase 2), and NCT01298687 (Phase 2). These trials evaluated its efficacy in lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Travoprost is the active ingredient in the brand-name product TRAVATAN. Clinical trials, such as NCT01298687, have studied the divided dose of TRAVATAN to assess its intraocular pressure lowering efficacy in patients with open-angle glaucoma or ocular hypertension.