AM-101 in the Treatment of Acute Tinnitus 2

This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of
repeated intratymanic AM-101 injections in the treatment of acute peripheral tinnitus (up to
3 months from onset).

Inclusion Criteria:

1. Persistent subjective peripheral tinnitus (unilateral or bilateral) following
traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery,
inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer
than 3 months prior to randomization

2. Age ≥ 18 years and ≤ 75 years (≥ 14 years and ≤ 75 years at selected sites);

3. Negative pregnancy test (woman of childbearing potential);

4. Willing and able to use adequate hearing protection, respectively to refrain from
engaging in activities or work involving loud noise exposure where sufficient hearing
protection is not possible or ensured;

5. Willing and able to protect ear canal and middle ear from water exposure as long as
tympanic membrane is not fully closed.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Fluctuating tinnitus;

2. Intermittent tinnitus;

3. Tinnitus resulting from traumatic head or neck injury;

4. Presence of chronic tinnitus;

5. Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing
loss;

6. History of repeated idiopathic sudden sensorineural hearing loss or history of
acoustic neuroma;

7. Ongoing acute or chronic otitis media or otitis externa;

8. Other treatment of tinnitus for the study duration;

9. Known hypersensitivity, allergy or intolerance to the study medication or any history
of severe, abnormal drug reaction;

10. Women who are breast-feeding, pregnant or who are planning to become pregnant during
the study;

11. Women of childbearing potential who are unwilling or unable to practice contraception,
such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with
a partner who has been vasectomised for at least three months;

12. Concurrent participation in another clinical study or participation in another
clinical study within 30 days prior to randomization.

Other protocol-defined exclusion criteria may apply.