OTO-201 for the Treatment of Acute Otitis Externa: Results from a Phase 3 Randomized Clinical Study.

OTO-201 for the Treatment of Acute Otitis Externa: Results from a Phase 3 Randomized Clinical Study. Ann Otol Rhinol Laryngol. 2019 Mar 02;:3489419830116 Authors: Ansley J, Mair EA, Namini H, Lu CH, LeBel C Abstract OBJECTIVES:: OTO-201 is a ciprofloxacin otic suspension previously approved by the US Food and Drug Administration to treat children with bilateral otitis media with effusion requiring tympanostomy tube placement. In this phase 3, double-blind, randomized, prospective, sham-controlled, multicenter study, a single dose of OTO-201 was administered to the external auditory canal in subjects with unilateral or bilateral acute otitis externa. METHODS:: Two hundred sixty-two subjects, 3 to 83 years of age, were randomized, and 260 subjects were included in the intent-to-treat analysis population: OTO-201 (0.2 mL, 12 mg, n = 130) or sham (air injection, n = 130). The primary efficacy measure was clinical cure (CC) on day 8, judged by blinded assessor for erythema, edema, otorrhea, and tenderness. Subjects were monitored over 28 days for efficacy and safety. RESULTS:: OTO-201 demonstrated a significant increase in CC compared with sham at day 8 (69.2% vs 46.1%, P
Source: The Annals of Otology, Rhinology, and Laryngology - Category: ENT & OMF Authors: Tags: Ann Otol Rhinol Laryngol Source Type: research

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ConclusionPaediatric temporal bone inflammatory processes are common and can have severe clinical sequelae. Timely intervention, facilitated by correct radiological diagnosis, can often prevent progression of disease, loss of hearing and systemic illness.
Source: Neuroradiology - Category: Radiology Source Type: research
CONCLUSION AND CLINICAL IMPORTANCE: Otitis externa in horses is a rare and treatable condition. The condition may be present for prolonged periods before owners become aware, compromising the welfare of affected horses. Untreated otitis externa is a suggested cause of otitis media and temporohyoid osteoarthropathy, emphasizing the importance of identifying and treating this condition at an early stage. For this reason, clinicians should include a brief inspection of the pinnae and external ear canal in the clinical examination of horses. PMID: 31218772 [PubMed - as supplied by publisher]
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CONCLUSION: With correct assessment of the different types of otitis externa, rapidly effective targeted treatment can be initi- ated, so that complications will be avoided and fewer cases will progress to chronic disease. PMID: 31064650 [PubMed - in process]
Source: Deutsches Arzteblatt International - Category: General Medicine Tags: Dtsch Arztebl Int Source Type: research
Implantable auditory devices (IADs) are a viable hearing restoration option for patients with hearing loss. Conditions such as chronic otitis externa, congenital aural atresia, and chronic otitis media can be treated with a variety of implants. Progressive disease are also amenable to restoration with IADs, providing stabilized hearing. When considering the best rehabilitative options, the patient ’s preference, ease of surgery, ease of device use, quality of life, and the traditional alternatives (such as ossiculoplasty, hearing aids, and cochlear implants) need to be considered. Patients with conductive, mixed, and...
Source: Otolaryngologic clinics of North America - Category: ENT & OMF Authors: Source Type: research
AbstractA number of infectious, inflammatory and idiopathic lesions develop within otologic tissues that may share similar clinical and/or microscopic features. This review first provides a working classification for otitis externa, and then otitis media and includes two recently described entities, eosinophilic otitis media and otitis media with ANCA-associated vasculitis. Next, the microscopic findings of a spectrum of otopathologic conditions are described, including post-inflammatory conditions such as tympanosclerosis and aural polyps, an overview of animate aural foreign body as well as iatrogenic aural foreign body ...
Source: Head and Neck Pathology - Category: Pathology Source Type: research
Date: August 13, 2018 Issue #:  1553Summary:  The FDA has approved a 6% otic suspension formulation of the fluoroquinolone antibiotic ciprofloxacin (Otiprio– Otonomy) for single-dose treatment of acute otitis externa (swimmer's ear) caused byPseudomonas aeruginosa orStaphylococcus aureus in patients≥6 months old.Otiprio was approved earlier for prophylaxis in children with bilateral otitis media with effusion who are undergoing tympanostomy tube placement.
Source: The Medical Letter - Category: Drugs & Pharmacology Authors: Tags: Ciprodex Ciprofloxacin Dexamethasone Fluoroquinolones Hydrocortisone Neomycin Ocuflox Otiprio Otitis media Pseudomonas aeruginosa Stapylococcus aureus Source Type: research
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Source: Veterinary Dermatology - Category: Veterinary Research Authors: Tags: Vet Dermatol Source Type: research
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