Dechra Announces FDA Approval of Otiserene Treatment for Canine Otitis Externa

Dechra, a global leader in veterinary specialty care, recently announced the FDA approval of Otiserene (marbofloxacin, terbinafine and dexamethasone otic suspension) to treat otitis externa in dogs.

It is the first single-dose, long-acting otitis externa product to leverage the powerful antibiotic marbofloxacin. As a one-time treatment administered in the veterinary clinic, Otiserene helps to keep otitis externa from disrupting the bond that people share with their dogs.

Otitis externa is a significant source of discomfort and stress for dogs, which is often reciprocated by their owners. In fact, otitis externa continues to be amongst the top three reasons for canine vet visits in the United States¹. This product gives veterinarians and pet owners the same convenience and benefits of other single-dose, long-acting otitis products, but now with a higher-tier antibiotic and powerful steroid designed for tough, long-lasting and recurrent otitis cases.

“With Otiserene, we will leverage the proven track record of marbofloxacin, now as part of a single-dose, long-acting solution for the treatment of challenging and recurrent canine otitis externa,” said Laura Olsen, president, North America, Dechra. “This addition not only expands Dechra’s dermatology offerings, it also adds a convenient, broad-spectrum option for veterinarians to use with confidence on their most challenging patients, ultimately fortifying the special bond that people share with their dogs.”

The addition of Otiserene builds on Dechra’s expansive otic offerings and continues to position Dechra as a veterinary specialty care provider of choice. The otic products in the Dechra dermatology portfolio give veterinarians the ability to recommend the most appropriate treatment per client and include:

• DuOtic (terbinafine and betamethasone acetate otic gel)
• Osurnia (florfenicol, terbinafine, betamethasone acetate) Otic Gel,
• Animax Ointment (nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide ointment),
• Mometavet (gentamicin sulfate, mometasone furoate anhydrous, and clotrimazole otic suspension)

Clinical Trial Results  

Otiserene was evaluated against a vehicle control in a randomized, well-controlled, masked field study of 232 client-owned dogs with otitis externa across the United States. At Day 30, 71.3 percent of dogs treated with Otiserene showed clinical improvement in ulceration, exudative discharge, redness, and swelling compared to just 26.3 percent in the control group, confirming its effectiveness in managing the key symptoms of otitis externa.

Otiserene is indicated for the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius) in dogs. Otiserene must be administered in the clinic by veterinary personnel. The product will be available for veterinarians to purchase through select veterinary distributors in late 2025.

¹Nationwide Mutual Insurance. Dermatitis, gastroenteritis among most common conditions that prompt veterinary visits [Internet]. Dermatitis, gastroenteritis among most common conditions that prompt veterinary visits . Nationwide Mutual Insurance; 2024 [cited 2024 Aug 6]. Available here.