Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SURF-100 · 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 10% or higher reduction in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.
| Arm | Type | Description |
|---|---|---|
| SURF-100 (a combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate) | EXPERIMENTAL | One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days |
| Mycophenolic Acid 0.1% | EXPERIMENTAL | One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days. |
| Mycophenolic Acid 0.3% | EXPERIMENTAL | One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days. |
| Betamethasone Sodium Phosphate 0.01% | EXPERIMENTAL | One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days. |
| Vehicle | PLACEBO_COMPARATOR | One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days. |
| Cyclosporine 0.05% Ophthalmic Emulsion | ACTIVE_COMPARATOR | One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days |
| Lifitegrast 5% Ophthalmic Solution | ACTIVE_COMPARATOR | One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days |
| Name | Type | Description |
|---|---|---|
| SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate) | DRUG | combination of a topical immunosuppressant and a topical corticosteroid solution |
| Mycophenolic Acid 0.1% | DRUG | topical immunosuppressant |
| Mycophenolic Acid 0.3% | DRUG | topical immunosuppressant |
| Betamethasone Sodium Phosphate 0.01% | DRUG | topical corticosteroid solution |
| Placebo Comparator: Vehicle | DRUG | topical vehicle solution |
| Cyclosporine 0.05% Ophthalmic Emulsion | DRUG | topical ophthalmic emulsion |
| Lifitegrast 5% Ophthalmic Solution | DRUG | topical ophthalmic solution |
Inclusion Criteria: 1. Adults at least 18 years of age at the time of the Screening visit. 2. Willing and able to read, sign, and date the informed consent form (ICF) after the nature of the study has been explained and any questions have been answered, and prior to initiation of any study procedur...
Top 4 of 6 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 |
| Bausch Health Companies Inc. | BHC | 1 | PHASE2 | BL1107 |
SURF-100 is an investigational small molecule eye drop being developed for dry eye disease. It is a fixed combination of 0.3% mycophenolic acid and 0.01% betamethasone sodium phosphate. Harrow, Inc. (ticker HROW) is developing the asset, which has completed a Phase 2 clinical trial in adults with dry eye disease.
SURF-100 is being studied as a treatment for dry eye disease in adults 18 years and older. It is an investigational combination eye drop, not an approved therapy, and its safety and efficacy have not been established. The completed Phase 2 study enrolled 349 participants with dry eye disease in the United States.
Harrow, Inc., which trades under the ticker HROW, is the developer of SURF-100. The company is advancing the combination eye drop for dry eye disease. Harrow is an ophthalmology-focused pharmaceutical company, and SURF-100 is one of its investigational pipeline assets in the ophthalmology therapeutic area.
SURF-100 has completed a Phase 2 clinical trial and remains an investigational therapy. It is not approved for any indication. The Phase 2 study in dry eye disease has finished, and no active trials of SURF-100 are currently listed. Further clinical development would be required before any regulatory submission.
SURF-100 has been evaluated in one clinical trial, NCT04734197, a Phase 2 study titled A Research Study To See How Well an Eye Drop, SURF-100 (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination), Works and What Side Effects There Are in Subjects With Dry Eye Disease. The trial is completed and enrolled 349 participants in the United States.