FDA

FDA OK’s Clotic for fungal otitis externa

October 10, 2025

Brand name: Clotic

Generic name: clotrimazole otic

Manufacturer: Laboratorios Salvat

Approval date: September 26, 2025

FDA has approved Clotic (clotrimazole otic solution) for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients ≥18 years of age.

Efficacy

Effectiveness and safety were evaluated in two phase 3, multicenter, randomized, double-blind, placebo-controlled trials in adult patients with unilateral or bilateral otomycosis and intact tympanic membranes (Trial 1, NCT03686384; Trial 2, NCT03686397). The treatment regimen consisted of instilling the contents of one single-dose vial of Clotic or placebo in the affected ear canal(s) twice daily for 14 consecutive days.

Therapeutic cure was defined as both clinical cure and mycological cure at the test-of-cure visit which occurred on day 24 to 26. Clinical cure was defined as a total signs/symptoms score of zero on a 4-point scale for pruritis, otalgia, ear fullness, and otorrhea. Mycological cure was defined as eradication (culture not showing growth of any fungal pathogen) or presumed eradication (no material to culture and overall clinical outcome is clinical cure). In both trials, Clotic demonstrated superiority to placebo in the MITT population for the proportion of patients with therapeutic cure.

In trial 1, the rates of therapeutic cure in Clotic and placebo groups were 58.5% and 27.8%, respectively. In trial 2, the rates of therapeutic cure in Clotic and placebo groups were 78.7% and 22.9%, respectively.

Safety

The most common adverse reactions (≥1 patient) were headache, application site pain, tinnitus, tympanic membrane perforation, and paresthesia.

Recommended dose

The prescribing information advises instilling the contents of one single-dose Clotic vial into the affected ear canal twice daily, morning and evening, preferably 12 hours apart for 14 consecutive days.

Clotic has only been studied in patients with intact tympanic membranes. The use of Clotic is not recommended for the treatment of otomycosis in patients with perforated tympanic membranes.

Source:

Clotic (clotrimazole otic) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217628s000lbl.pdf Revised September 2025. Accessed October 9, 2025.