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Also known as MK2452
Preservative-Free Tafluprost · 2 trials · 3 indications
IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by \>2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one "study eye" was identified for data summarization and analysis for this primary efficacy outcome measure. The "study eye" was the eye with the higher (i.e., "worse") IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the "study eye." Change from baseline in IOP at Week 4 = Week 4 IOP value - baseline IOP value.
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with one or more AEs during the study are counted once in this summary.
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE are counted once in this summary.
IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP). IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12). Lowering elevated IOP is a treatment goal of glaucoma.
| Arm | Type | Description |
|---|---|---|
| Tafluprost | EXPERIMENTAL | One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks. Morning dose with vehicle only allows blinding to match twice daily dosing of comparator arm. |
| Timolol | ACTIVE_COMPARATOR | One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks. |
| timolol maleate | ACTIVE_COMPARATOR | Preservative-free timolol maleate |
| Name | Type | Description |
|---|---|---|
| Preservative-Free Tafluprost or vehicle | DRUG | Preservative-free tafluprost (0.0015%) ophthalmic solution; Preservative-free vehicle ophthalmic solution (contains no active drug) |
| Preservative-Free Timolol maleate | DRUG | Preservative-free timolol maleate (0.5%) ophthalmic solution |
| Preservative-Free Tafluprost | DRUG | One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks |
| Comparator: timolol | DRUG | One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks |
Inclusion Criteria: * Participant has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension * Has been using ocular hypotensive medication on a stable treatment regimen for at least 30 days prior to screening, or is treatme...
Top 5 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 6 | PHASE3 | Gen 2 Travoprost Intracameral, Travoprost |
| SpyGlass Pharma, Inc. | SGP | 5 | PHASE3 | Bimatoprost System, BIM-DRS |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | AGN-193408 |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE3 | Bimatoprost ophthalmic solution |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE1 | REGN22530 |
Preservative-Free Tafluprost is used for the treatment of open-angle glaucoma and ocular hypertension. It is a preservative-free formulation of tafluprost, a small molecule eye drop developed by Merck & Company, Inc. (MRK). The drug is intended for patients aged 18 years and older and has been studied in Phase 3 clinical trials.
Preservative-Free Tafluprost is developed by Merck & Company, Inc., which trades under the ticker MRK. The company sponsored the Phase 3 clinical program for the drug, including the trials registered as NCT01254604 and NCT01026831, which evaluated the preservative-free formulation in patients with open-angle glaucoma or ocular hypertension.
Preservative-Free Tafluprost has completed Phase 3 clinical development. Two Phase 3 trials, NCT01254604 and NCT01026831, have been completed, and no trials are currently active. The program enrolled a total of 643 participants across the studies, which were randomized, double-blind, and active-controlled.
Preservative-Free Tafluprost has been studied in two completed Phase 3 trials. NCT01254604 evaluated the drug in open-angle glaucoma or ocular hypertension with 190 participants, and NCT01026831 studied it in open-angle glaucoma or ocular hypertension with 643 participants. Both trials enrolled adults aged 18 years and older and used randomized, double-blind, active-controlled designs.
Preservative-Free Tafluprost is a preservative-free formulation of tafluprost, also referred to by the development code MK-2452 or MK2452. It contains the same active small molecule as tafluprost but is formulated without preservatives. The Phase 3 trials NCT01254604 and NCT01026831 were conducted under the MK-2452 designation.