Bayer’s Claro becomes first single-dose otitis externa therapy. By Joseph Harvey, Animal Pharm

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Bayer HealthCare Animal Health has secured US approval for its first single-dose therapy to treat susceptible strains of common pathogens found in canine otitis externa.

Claro (15.0 mg/mL florfenicol, 13.3 mg/mL terbinafine, 2.0 mg/mL mometasone furoate) Otic Solution is expected to be available for sale exclusively to veterinarians in November. It is indicated for the treatment of canine otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

The product is a clear liquid solution featuring a fixed combination of antibacterial, antifungal and anti-inflammatory ingredients that requires only one, veterinarian-administered treatment. Bayer said the single-dose treatment regimen “eliminates veterinarian uncertainty about pet owner compliance and spares pet owners the frustrations of in-home application and multiple treatment visits”.

Results of Piedmont partnership

Claro was developed as part of an agreement with North Carolina company Piedmont Animal Health, which the Bayer described as a “potential market leader” in an exclusive Animal Pharm interview last month.

This is the second approval in the US this year for a product emerging from the Piedmont-Bayer partnership. February saw the US approval of advantus (imidacloprid), an antiparasitic soft chewable tablet for dogs.

Otitis externa competition

According to Bayer, otitis externa – inflammation of the ear canal – is the second most common reason dog owners take their dog to a veterinarian. The condition can cause pain, itching, a strong odor and muffled hearing in dogs.

The majority of existing treatments for canine otitis externa in the US have daily dose recommendations. For instance, Bayer also sells its daily Baytril Otic topical emulsion in the US for the treatment of canine otitis externa due to bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine.

Merck Animal Health sells once-a-day Posatex Otic Suspension in the US for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).

Virbac’s Easotic is a daily treatment indicated for the treatment of otitis externa caused by Malassezia pachydermatis and the bacterium Staphylococcus pseudintermedius, while Bioniche Life Sciences developed theTri-Otic ointment for acute and chronic otitis externa in dogs – the firm is now owned by Vétoquinol.

However, Elanco launched Osurnia (florfenicol/terbinafine/betamethasone acetate) in August 2015, a two-dose treatment.