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AL-60371, 0.3% otic · 2 trials · 1 indication
An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. Proportion of patients is reported as percentage of participants.
| Arm | Type | Description |
|---|---|---|
| AL-60371 | EXPERIMENTAL | AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days |
| Vehicle | PLACEBO_COMPARATOR | AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days |
| Name | Type | Description |
|---|---|---|
| AL-60371, 0.3% otic suspension | DRUG | Investigational otic suspension intended for the treatment of acute otitis externa |
| AL-60371 Vehicle | DRUG | Inactive ingredients used as placebo |
Inclusion Criteria: * At least 6 months of age. * Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of presumed bacterial origin in at least one ear. * Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for tenderness, erythema, and edema....
AL-60371 0.3% otic is an investigational topical otic suspension being developed for the treatment of acute otitis externa, commonly known as swimmer's ear. It is a small molecule formulation administered directly into the ear canal. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
AL-60371 0.3% otic is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is a global medical device and pharmaceutical company focused on eye care and related conditions. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational treatment.
AL-60371 0.3% otic is in Phase 3 clinical development for acute otitis externa. Two Phase 3 trials have been completed, with a combined enrollment of 1,357 participants. The drug remains investigational and is not yet approved for commercial use. Further regulatory review would be required before it could be marketed.
AL-60371 0.3% otic has been studied in two completed Phase 3 trials: NCT01535560 with 589 participants and NCT01535599 with 768 participants. Both trials evaluated the safety and efficacy of the topical otic suspension in patients aged 6 months and older with acute otitis externa. The trials were randomized, double-blind, and placebo-controlled.
AL-60371 0.3% otic is a small molecule formulated as a topical otic suspension. Its specific molecular target has not been disclosed in available information. The drug is administered directly into the ear canal to treat acute otitis externa, an infection and inflammation of the outer ear canal.