Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EXE844 Sterile Otic, 0.3% · 3 trials · 2 indications
A sustained clinical cure was attained if otorrhea was absent in the study ear at Day 8 (EOT) per the Investigator assessment and continued to be absent through the end of the study. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).
Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (\<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (\<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.
Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (\<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (\<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.
Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (\<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (\<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.
Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (\<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (\<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.
Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (\<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (\<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.
Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (\<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (\<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.
| Arm | Type | Description |
|---|---|---|
| EXE844 for 7 Days + Tubes | EXPERIMENTAL | EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion |
| EXE844 for 3 Days + Tubes | EXPERIMENTAL | EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion |
| Tubes Only | ACTIVE_COMPARATOR | Bilateral myringotomy and tympanostomy tube insertion |
| EXE844 | EXPERIMENTAL | EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion |
| Name | Type | Description |
|---|---|---|
| EXE844 Sterile Otic Suspension, 0.3% | DRUG | - |
| Tympanostomy Tube Insertion | PROCEDURE | Surgical procedure for treating pediatric cases of recurrent or chronic otitis media |
Inclusion Criteria: * Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion. * Suspected bacterial infection at time of surgery in at least 1 ear. * Willing to refrain from water immersion of the ears ...
EXE844 Sterile Otic, 0.3% is an investigational small molecule being developed for otitis media with effusion in children, as well as recurrent otitis media. It is administered as an otic suspension at the time of tympanostomy tube insertion. The drug is in Phase 3 clinical development.
EXE844 Sterile Otic, 0.3% is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker ALC. Alcon is conducting clinical trials to evaluate the safety and efficacy of this otic suspension in pediatric patients with otitis media.
EXE844 Sterile Otic, 0.3% is in Phase 3 clinical development. Two Phase 3 trials have been completed, along with one Phase 1 pharmacokinetic study. The drug is investigational and has not been approved by regulatory authorities.
EXE844 Sterile Otic, 0.3% has been studied in three completed trials. NCT02432105 and NCT02436304 are Phase 3 trials evaluating safety and efficacy in otitis media at tympanostomy tube insertion, enrolling 470 and 404 patients respectively. NCT02539654 is a Phase 1 pharmacokinetic study with 14 patients.
EXE844 Sterile Otic, 0.3% is the primary name for this investigational otic suspension. No alternative names have been reported for this drug in the clinical trial data. It is identified solely as EXE844 Sterile Otic, 0.3% across the studies.