Approval Probability
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SUN-131 1.5% TDS · 1 trial · 1 indication
Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.
| Arm | Type | Description |
|---|---|---|
| SUN-131 1.5% TDS | EXPERIMENTAL | Subjects will be randomly assigned to receive SUN-131 1.5% TDS for the affected eye. All patches will be worn for 16±4 hours each day for 21 days. |
| Placebo TDS | PLACEBO_COMPARATOR | Placebo Patch for Blinding Purposes |
| Name | Type | Description |
|---|---|---|
| SUN-131 1.5% TDS | DRUG | Active transdermal patch |
| Placebo TDS | DRUG | Placebo transdermal patch for blinding |
Inclusion Criteria: * 18 years of age or older of either sex and any race * Chalazion with visible single granuloma in an upper or lower eyelid. If more than one eyelid is diagnosed with a chalazion, the most inflammatory chalazion shall be selected as the study eyelid. Other eyelids containing a c...
SUN-131 1.5% TDS is an investigational small molecule being developed for the treatment of chalazion, a common eyelid condition. It is administered as a topical delivery system (TDS). The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
SUN-131 1.5% TDS is being developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker BWAY. The company is conducting clinical research to evaluate the safety and efficacy of this topical treatment for chalazion.
SUN-131 1.5% TDS is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of chalazion in adult patients.
SUN-131 1.5% TDS has one completed Phase 2 clinical trial registered as NCT02338648. This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of SUN-131 TDS compared to placebo in 60 adult patients with a chalazion in the United States.
SUN-131 1.5% TDS is a small molecule administered topically as a delivery system. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated for its potential to treat chalazion, a condition involving eyelid inflammation.