Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as EXE844 Sterile Otic Suspension, 0.3%
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 studied for otitis media with effusion in children, including recurrent otitis media. It is evaluated in pediatric patients at the time of tympanostomy tube insertion. It is not approved and remains in clinical development.
EXE844 Sterile Otic, 0.3% is being developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor of the clinical program studying the otic suspension in pediatric otitis media with effusion at the time of tympanostomy tube insertion.
EXE844 Sterile Otic, 0.3% has completed Phase 3 clinical development. Two Phase 3 safety and efficacy trials and one Phase 1 pediatric pharmacokinetic study have been completed. The program includes 888 enrolled patients across three trials, and no trials are currently active.
EXE844 Sterile Otic, 0.3% has been studied in three completed trials: NCT02432105 and NCT02436304, both Phase 3 safety and efficacy studies in otitis media at tympanostomy tube insertion, and NCT02539654, a Phase 1 pediatric pharmacokinetic study. The Phase 3 trials enrolled 470 and 404 patients respectively.
Yes. EXE844 Sterile Otic Suspension, 0.3% is an alternative name for EXE844 Sterile Otic, 0.3%. Both refer to the same Alcon investigational otic small molecule developed for otitis media with effusion in children at the time of tympanostomy tube insertion.
The Phase 3 trials of EXE844 Sterile Otic, 0.3% were randomized and active controlled, enrolling children as young as 6 months of both sexes. The studies evaluated safety and efficacy in otitis media with effusion and recurrent otitis media at the time of tympanostomy tube insertion. The trials were not double blind.