Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pilocarpine Ophthalmic Topical Cream, Dose 1
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...
Top 3 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-319 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
Pilocarpine, Dose 1 is an investigational small molecule developed by Glaukos Corporation for ophthalmic use. It is being studied in Phase 2 clinical development for Dry Eye Disease and Presbyopia, and it is formulated as an ophthalmic topical cream rather than a conventional eye drop.
Pilocarpine, Dose 1 is being developed for two eye conditions: Dry Eye Disease and Presbyopia. Both are non-surgical ophthalmic indications, and the program has been studied in adults, including patients aged 40 years and older in the presbyopia trial.
Pilocarpine, Dose 1 targets the muscarinic acetylcholine receptors CHRM1 and CHRM3, where it acts as an agonist. By activating these receptors, the drug is designed to produce a pharmacological effect in the eye relevant to its Dry Eye Disease and Presbyopia indications.
Pilocarpine, Dose 1 is being developed by Glaukos Corporation, which trades on the New York Stock Exchange under the ticker GKOS. Glaukos is an ophthalmology-focused company, and this asset is part of its clinical-stage pipeline.
Pilocarpine, Dose 1 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The program has one completed Phase 2 trial, and no trials are currently listed as active.
Pilocarpine, Dose 1 has been evaluated in two completed Phase 2 trials. NCT05124275 studied the ophthalmic topical cream in Presbyopia with 123 participants, and NCT05119920 studied it in Dry Eye Disease and keratoconjunctivitis sicca with 226 participants. Both were randomized, double-blind, placebo-controlled trials conducted in the United States.
Yes. Pilocarpine, Dose 1 is also known as Pilocarpine Ophthalmic Topical Cream, Dose 1. The two names refer to the same Glaukos Corporation investigational asset, which is a small molecule formulated as a topical cream for ophthalmic administration.