FDA Approves Otiserene® for Treatment of Canine Otitis Externa
Dechra announces the recent 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.”
An Expansive Dermatology Portfolio, With a Focus on Otic Solutions
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% of dogs treated with Otiserene® showed clinical improvement in ulceration, exudative discharge, redness, and swelling compared to just 26.3% in the control group, confirming its effectiveness in managing the key symptoms of otitis externa.
How to Use
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. Administer one dose (1 tube) per affected ear(s) and shake before use. It is the same dose for any dog, regardless of size and weight, and is easy to administer from a pre-measured, single-dose tube, helping to ensure the right dose every time.
The product will be available for veterinarians to purchase through select veterinary distributors in late 2025.
Otiserene® (marbofloxacin, terbinafine, and dexamethasone otic suspension) contains 15.1 mg marbofloxacin, 22.7 mg terbinafine (equivalent to 25.5 mg terbinafine hydrochloride), and 2.01 mg dexamethasone. Inactive ingredients include mineral oil and paraffin. Otiserene® is indicated for treating otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius) in dogs. Use only as directed.
IMPORTANT SAFETY INFORMATION:
To obtain a full Safety Data Sheet, contact Dechra at 1-866-933-2472.
As with all drugs, side effects may occur. Do not use in cats. For otic use in dogs only. Restrain the dog to minimize post application head shaking. Do not administer orally. Do not use in dogs with known tympanic membrane perforation, or with known or suspected hypersensitivity to marbofloxacin, terbinafine, or dexamethasone. Use with caution in dogs with impaired hepatic function. The following adverse reactions were reported: anorexia/decreased appetite, pruritus, vomiting, conjunctivitis/eye inflammation. The safe use of Otiserene® has not been evaluated in dogs that are pregnant, lactating, or intended for breeding. Not for use in humans. Keep this and all medications out of the reach of children. In case of accidental ingestion by humans, contact a physician immediately. Avoid skin and eye contact. Humans with known hypersensitivity to any of the active ingredients in Otiserene® should not handle this product. Refer to the prescribing information for complete details or visit www.dechra‐us.com.
