Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pilocarpine, Dose 1 · 2 trials · 3 indications
Mean change from baseline in the VAS score at Day 28 visit. Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)
Proportion of treatment responders \[subjects gaining 3 lines or more in binocular distance corrected near visual acuity (DCNVA) and not losing more than 5 letters of binocular best corrected distance visual acuity (BCDVA)\] 1 hour post-dose at the Day 28 visit.
| Arm | Type | Description |
|---|---|---|
| Pilocarpine Ophthalmic Topical Cream, Dose 1 | EXPERIMENTAL | Pilocarpine Ophthalmic Topical Cream, Dose 1 |
| Pilocarpine Ophthalmic Topical Cream, Dose 2 | EXPERIMENTAL | Pilocarpine Ophthalmic Topical Cream, Dose 2 |
| Pilocarpine Ophthalmic Topical Cream, Dose 3 | EXPERIMENTAL | Pilocarpine Ophthalmic Topical Cream, Dose 3 |
| Placebo Ophthalmic Topical Cream | PLACEBO_COMPARATOR | Placebo Ophthalmic Topical Cream |
| Name | Type | Description |
|---|---|---|
| Pilocarpine Ophthalmic Topical Cream, Dose 1 | DRUG | Pilocarpine Ophthalmic Topical Cream, Dose 1 |
| Pilocarpine Ophthalmic Topical Cream, Dose 2 | DRUG | Pilocarpine Ophthalmic Topical Cream, Dose 2 |
| Pilocarpine Ophthalmic Topical Cream, Dose 3 | DRUG | Pilocarpine Ophthalmic Topical Cream, Dose 3 |
| Placebo Ophthalmic Topical Cream | DRUG | Placebo Ophthalmic Topical Cream |
Inclusion Criteria: * Male or female, 18 years of age or older at the Screening Visit * Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form * Diagnosis of dry eye Exclusion Criteria: * Sensitivity or known allergy to pilocarpine or any of the other e...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | ABBV-444, REFRESH OPTIVE UD |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
| Alcon AG | ALC | 1 | N/A | Undisclosed |
| Harrow, Inc. | HROW | 1 | - | Undisclosed |
Pilocarpine, Dose 1 is an investigational small molecule being developed by Glaukos Corporation for the treatment of presbyopia and dry eye disease. It is administered as an ophthalmic topical cream. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Pilocarpine, Dose 1 is being developed by Glaukos Corporation, a company traded on the New York Stock Exchange under the ticker symbol GKOS. The company is conducting clinical trials to evaluate the safety and efficacy of this ophthalmic topical cream for presbyopia and dry eye disease.
Pilocarpine, Dose 1 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one for dry eye disease and one for presbyopia. The drug remains investigational and has not received FDA approval for any indication.
Pilocarpine, Dose 1 has completed two Phase 2 clinical trials. NCT05119920 evaluated the drug in 226 patients with dry eye disease, and NCT05124275 evaluated it in 123 patients with presbyopia. Both trials were randomized, double-blind, placebo-controlled studies conducted in the United States.
Pilocarpine, Dose 1 is a specific formulation of pilocarpine, developed as an ophthalmic topical cream by Glaukos Corporation. While pilocarpine is a well-known medication, this product is being investigated specifically for presbyopia and dry eye disease, and it is not approved for these uses.