Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail

Inclusion Criteria:

- Male and females 18 - 74 years of age inclusive

- Fungal toenail infection of one or both of the large (great) toenails

- The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and
non-dermatophyte] are not allowed)

- Willingness not to have professional pedicures or application of any nail polish
product or nail cosmetics to the toenails after the screening visit

Exclusion Criteria:

- History of any significant chronic fungal disease other than onychomycosis or
immunocompromised condition

- Any abnormalities of the nail or previous surgery of the toenail that could prevent a
normal appearing nail if clearing of infection is achieved

- Significant confounding conditions as assessed by the study doctor

- Participation in any other trial of an investigational drug or device within 30 days
or participation in a research study concurrent with this study

- No administration of systemic antifungal medications within 6 months prior to
screening visit

- No application of prescription topical antifungal medications for toenail fungus
within 3 months or other commercially available topical medications for toenail fungus
applied directly to the toenails within 1 month prior to screening visit

- Tinea pedis (athlete's foot) that would require systemic treatment

Other protocol-defined inclusion/exclusion criteria may apply