Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Varenicline · 2 trials · 1 indication
Percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline
To evaluate the Cmax of varenicline in adult Chinese with dry eye disease (DED) after the first dosing at Visit 1 \[Day 1\] and after the last dosing at Visit 3 \[Day 28\], respectively.
To evaluate the Tmax of varenicline in adult Chinese subjects with DED after the first dosing at Visit 1 \[Day 1\] and after the last dosing at Visit 3 \[Day 28\], respectively.
To evaluate the AUCtau of varenicline in adult Chinese subjects with DED after the first dosing at Visit 1 \[Day 1\] and after the last dosing at Visit 3 \[Day 28\], respectively.
To evaluate the AUC0-last of varenicline in adult Chinese subjects with DED after the first dosing at Visit 1 \[Day 1\] and after the last dosing at Visit 3 \[Day 28\], respectively.
To evaluate the T1/2 of varenicline after the last dosing at Visit 3 \[Day 28\] in adult Chinese subjects with DED.
To evaluate the λz of varenicline after the last dosing at Visit 3 \[Day 28\] in adult Chinese subjects with DED.
| Arm | Type | Description |
|---|---|---|
| OC-01 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Varenicline Tartrate Nasal Spray | DRUG | Intranasal delivery of OC-01 (varenicline solution) 0.6 mg/mL twice a day (BID) for 28 days |
| Placebo (vehicle) | DRUG | Intranasal delivery of placebo (vehicle) twice a day (BID) for 28 days |
Inclusion Criteria: * Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit Exclusion Criteria: * Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in either eye within three months or refra...
| 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 |
Varenicline, developed as OC-01 nasal spray, is an investigational small molecule being studied for the treatment of Dry Eye Disease. It is delivered as a nasal spray and is currently in clinical development, with Phase 3 trials completed. The drug is not yet approved and remains investigational.
Varenicline is a small molecule that acts as a nicotinic acetylcholine receptor agonist. It is being studied for its effects on the signs and symptoms of Dry Eye Disease when administered as a nasal spray. The exact mechanism in this context is under investigation.
Varenicline is being developed by Milestone Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker MIST. The company is conducting clinical trials for the drug as a treatment for Dry Eye Disease.
Varenicline is in Phase 3 clinical development for Dry Eye Disease. A Phase 3 trial has been completed, along with a Phase 1 pharmacokinetic study. The drug is investigational and has not received FDA approval.
Varenicline has been studied in two completed clinical trials in China. NCT05378945 is a Phase 3 trial evaluating the efficacy and safety of OC-01 nasal spray in 340 adults with Dry Eye Disease. NCT05576415 is a Phase 1 trial assessing pharmacokinetics, pharmacodynamics, safety, and tolerability in 9 adults.
Yes, Varenicline is the same as OC-01. The drug is referred to as OC-01 in clinical trial titles, and both names refer to the same investigational nasal spray being developed for Dry Eye Disease.