Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Moxidex otic · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Moxidex | EXPERIMENTAL | Moxidex otic solution |
| Moxifloxacin | ACTIVE_COMPARATOR | Moxifloxacin otic solution |
| Dexamethasone | ACTIVE_COMPARATOR | Dexamethasone phosphate otic solution |
| FLOXIN | ACTIVE_COMPARATOR | Ofloxacin otic solution |
| TT only | OTHER | Tympanostomy tubes only |
| Name | Type | Description |
|---|---|---|
| Moxidex otic solution | DRUG | 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days |
| Moxifloxacin otic solution | DRUG | 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days |
| Dexamethasone phosphate otic solution | DRUG | 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days |
| Tympanostomy tubes | DEVICE | Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media with effusion in children |
| Ofloxacin otic solution | DRUG | 5 drops into the infected ear(s) twice daily (morning and evening) for 10 days |
Inclusion Criteria: * Clinical diagnosis of AOE based on clinical observation and of presumed bacterial origin * A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema * Other protocol-defined inclusion criteria may apply Exclusion Criteria:...
Moxidex otic is an investigational small molecule being developed for acute otitis media and acute otitis externa, which are ear infections. It is formulated as an otic, or ear, preparation. The drug is in Phase 3 clinical development and has not been approved by the FDA.
Moxidex otic is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is conducting clinical trials to evaluate the safety and efficacy of this investigational ear drop formulation for treating acute ear infections.
Moxidex otic is in Phase 3 clinical development. It has completed three clinical trials, including two Phase 3 studies and one Phase 2 study. The drug is investigational and has not received FDA approval. All completed trials were randomized, double-blind, and active-controlled.
Moxidex otic has completed three clinical trials. NCT00578474 and NCT00579189 were Phase 3 studies in acute otitis media with tympanostomy tubes, enrolling 911 and 776 patients respectively. NCT00578773 was a Phase 2 study in peri-operative tube otorrhea with 303 patients. NCT00750633 was a Phase 3 study in acute otitis externa with 990 patients.
No, Moxidex otic is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The completed trials were active-controlled and double-blind, but the drug has not yet received regulatory approval for any indication.