AM-101 in the Treatment of Post-Acute Tinnitus 1

This open-label extension study is assessing the safety and local tolerance of repeated
treatment cycles of AM-101 in subjects previously treated in the scope of the TACTT2 study
(NCT01803646).

Inclusion Criteria:

- Completion of TACTT2 study;

- Negative pregnancy test (woman of childbearing potential);

- Willing and able to attend the study visits during at least one treatment cycle.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Adverse event leading to treatment discontinuation in TACTT2;

- Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating
hearing loss, otitis media, otitis externa, abnormality of tympanic membrane;

- Ongoing drug-based therapy for otitis media or otitis externa;

- Drug-based therapy known as potentially tinnitus-inducing;

- Other treatment of tinnitus;

- Drug abuse or alcoholism;

- Subjects with psychiatric diseases requiring drug treatment;

- Use of antidepressant or anti-anxiety medication;

- Any clinically relevant disorder or abnormality in physical examination;

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

- Women of childbearing potential who are unwilling or unable to practice contraception.

Other protocol-defined exclusion criteria may apply.