Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
0.02% Betamethasone · 1 trial · 1 indication
The UNC DEMS scale is a participant-specific 10-point scale with a minimum score of 1 (\[1-2\] My symptoms are not a problem. My dry eye does not affect my daily life at all) and a maximum score of 10 (\[9-10\] my symptoms are severe and I need immediate medical care. My dry eye greatly affects my daily life). Participants with a minimum reduction of ≥1 point in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.
| Arm | Type | Description |
|---|---|---|
| SURF-200 (0.02% betamethasone sodium phosphate in vehicle) | EXPERIMENTAL | One drop twice daily (BID) in the study eye for 14 days. |
| SURF-200 (0.04% betamethasone sodium phosphate in vehicle) | EXPERIMENTAL | One drop BID in the study eye for 14 days. |
| Vehicle | PLACEBO_COMPARATOR | One drop BID in the study eye for 14 days. |
| Name | Type | Description |
|---|---|---|
| 0.02% Betamethasone Sodium Phosphate | DRUG | topical corticosteroid solution |
| 0.04% Betamethasone Sodium Phosphate | DRUG | topical corticosteroid solution |
| Placebo | DRUG | topical vehicle solution |
Inclusion Criteria: 1. Subjects 18 years of age and older who have a diagnosis of dry eye disease and experiencing an episodic flare up. Criteria for the diagnosis must include the following: 1. UNC DEMS score of greater than or equal to 5 but less than or equal to 9 2. Conjunctival hyperemi...
| 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 |
0.02% Betamethasone is an investigational small molecule being developed for the treatment of Dry Eye Disease. It is formulated as an eye drop and is intended to address episodic flare-ups of the condition. The drug is currently in clinical development and has not been approved by the FDA.
0.02% Betamethasone is being developed by Harrow, Inc., a pharmaceutical company traded on the NASDAQ under the ticker symbol HROW. The company is conducting clinical research to evaluate the safety and efficacy of this eye drop formulation for Dry Eye Disease.
0.02% Betamethasone is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received FDA approval. The Phase 2 trial has been completed, and the results will inform whether the drug advances to later stages of development.
0.02% Betamethasone was studied in a Phase 2 clinical trial registered as NCT04734210. This randomized, double-blind, placebo-controlled study enrolled 139 participants in the United States to evaluate the drug's efficacy and side effects compared with a vehicle in subjects experiencing an episodic flare-up of Dry Eye Disease. The trial has been completed.
Yes, 0.02% Betamethasone is also known as SURF-200. The clinical trial NCT04734210 refers to the drug as SURF-200, and it is being investigated as an eye drop for the treatment of Dry Eye Disease. Both names refer to the same investigational product.