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...
| 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 |