Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)

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 following surgery without the use
of adequate ear protection during swimming, bathing, showering and other
water-related activities.

- Legally Authorized Representative (LAR) must read and sign the informed consent.

- Parent or caregiver must agree to comply with the requirements of the study and
administer study medication as directed, complete required study visits, and comply
with the protocol.

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Previous otologic or otologic-related surgery within the past 30 days or ongoing
complications.

- Middle ear pathology in either ear other than otitis media.

- Current acute otitis externa (AOE), malignant otitis externa (MOE) or other
conditions which could interfere with evaluation of the study drug.

- Any systemic disease or disorder, complicating factor or structural abnormality that
would negatively affect the conduct or outcome of the study based upon assessment by
the Investigator.

- Known or suspected allergy or hypersensitivity to quinolones or other active or
inactive ingredients present in the medications to be used in the study.

- Other protocol-specified exclusion criteria may apply.