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Varisolve · 1 trial · 1 indication
The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = \[(Raw Score) - 5\] \* 4.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Varisolve (polidocanol endovenous mircofoam) |
| 2 | PLACEBO_COMPARATOR | Agitated saline |
| Name | Type | Description |
|---|---|---|
| Varisolve (Polidocanol Endovenous Microfoam) | DRUG | 1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2) |
| Agitated Saline | DRUG | 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session |
Inclusion Criteria: * Males and Females 18-65 years old * VEINES Sym Score less than 75 points * Varicose Vein clinical classification CEAP 2, 3, 4, or 5 * Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein * Superficial venous disease manifested by both sympt...
Varisolve is an investigational small molecule being developed for the treatment of varicose veins. It is a polidocanol injectable foam designed to address symptomatic, visible varicose veins with saphenofemoral junction (SFJ) incompetence. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Varisolve is being developed by Boston Scientific Corporation, a company publicly traded under the ticker symbol BSX. The drug is currently in Phase 2 clinical development for the treatment of varicose veins and remains investigational, meaning it has not yet received regulatory approval.
Varisolve is in Phase 2 clinical development. It is an investigational drug for the treatment of varicose veins and has not been approved by the FDA or any other regulatory agency. The drug is still undergoing clinical trials to evaluate its safety and efficacy.
Varisolve has one completed clinical trial, registered under NCT00758420. This was a randomized, single-blind, placebo-controlled Phase 2 study that enrolled 77 participants in the United States to evaluate the efficacy and safety of polidocanol injectable foam for symptomatic, visible varicose veins with SFJ incompetence. The trial has been completed.
No, Varisolve is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of varicose veins. The drug has completed one clinical trial but has not yet received regulatory approval, and its safety and efficacy have not been fully established.