FST-201 In The Treatment of Acute Otitis Externa

Inclusion Criteria:

- Have a clinical diagnosis of AOE in one or both ears, defined as a clinical score of
at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for
tenderness (absent=0, present=1).

- Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and
any race.

- Provide written informed consent or parental assent.

- Be willing and able to follow all instructions and attend all study visits

Exclusion Criteria:

All subjects must not:

- Have known sensitivity to any component of the study medications

- Have a current infection requiring systemic antimicrobial treatment

- Have used topical or systemic pain meds on the same day as Screening/Baseline Visit 1
and for the duration of the study.

- Take any systemic (within 30 days) or otic corticosteroids (within 1 days) prior to
Screening/Baseline Visit 1

- Current use of topical or systemic non-steroidal or other anti-inflammatory drugs.

- Use any topical otic treatment with alcohol, vinegar, hydrogen peroxide or other
astringent medication during the course of the study or on the same day as
Screening/Baseline Visit 1

- Have taken any antibiotics within 3 days prior to Visit 1

- Have signs and symptoms of AOE for > 4 weeks at Screening/Baseline Visit 1

- Have a non-intact or perforated tympanic membrane in the enrolled ear

- Have a clinical diagnosis of chronic suppurative otitis media, acute otitis media or
acute otorrhea in patients with tympanostomy tubes

- Have a clinical diagnosis of malignant otitis externa

- Have overt fungal AOE

- Have a viral infection of the pinna or tympanic membrane (i.e herpes zoster)

- Have congenital abnormalities of the external auditory canal in the enrolled ear(s)

- Have obstructive bony exostoses in the enrolled ear(s)

- Have mastoid or other suppurative, non-infectious ear disorders (e.g, cholesteatoma)

- Have malignant tumors of the external auditory canal

- Have a history of otologic surgery. Surgery performed more than 1 year prior to
Screening/Baseline Visit 1and limited to the tympanic membrane is allowed

- Have seborrheic dermatitis of the external auditory canal

- Have a current or prior history of immunosuppressive disorders

- Have acute or chronic renal insufficiency, hepatitis or diabetes mellitus

- Be pregnant, nursing or planning a pregnancy.