Oticara

Sinusitis

Inflammation of the sinus tissue affects tens of millions of people in the United States with the more severe chronic cases undergoing surgery to improve sinus ventilation and enable better access to therapies.^{[1]1.Blackwell DL, Lucas JW, Clarke TC, Summary health statistics for U.S. adults: National Health Interview Survey, 2012. National Center for Health Statistics. Vital Health Stat 10(260). 2014:19.}This surgery is called functional endoscopic sinus surgery or FESS and, in most cases, successfully treats these patients’ symptoms.^{[2]2.Soler ZM, Jones R, et. Al., Sino‐Nasal outcome test‐22 outcomes after sinus surgery: A systematic review and meta‐analysis. Laryngoscope, 2018 Mar; 128(3):581–592}Unfortunately, for many of the people who undergo FESS annually^{[3]3. Bhattacharyya N, Ambulatory sinus and nasal surgery in the United States: Demographics and perioperative outcomes, Laryngoscope, 2010 Mar; 120(3):635-638}, complete resolution of symptoms is not achieved and need additional treatments either following surgery or years later despite use to of available therapies.^{[4]4.Soler ZM, Smith TL, Quality of Life Outcomes after Functional Endoscopic Sinus Surgery, Otolaryngol Clin North Am. 2010 Jun; 43(3): 605–612.[5]5.Smith TL, Litvack JR, et. Al., Determinants of outcomes of sinus surgery: a multi-institutional prospective cohort study, Otolaryngol Head Neck Surg. 2010;142(1):55–63[6]6.Dursun E, Korkmaz H, et al., Clinical predictors of long-term success after endoscopic sinus surgery, Otolaryngol Head Neck Surg. 2003;129(5):526–531[7]7.Desrosiers MY, Kilty SJ, Treatment alternatives for chronic rhinosinusitis persisting after ESS: What to do when antibiotics, steroids and surgery fail. Rhinology, 46, 3-14, 2008}

Clinical use of Oticara’s sinusitis treatment has shown promising significant reduction of symptoms in post-FESS sinusitis patients and additional studies are being planned to validate these results.

Otitis Externa

Millions of cases of acute otitis externa (AOE; infection of the outer ear) are reported each year.^{[8]8.Anon., Estimated Burden of Acute Otitis Externa — United States, 2003—2007, Morbidity and Mortality Weekly Report (MMWR)/CDC, 2011; 60(19);605-609}While there are several FDA approved treatments for bacterial based infections, up to 30% of AOE are fungal based^{[9]9.Munguia R, Daniel SJ, Ototopical antifungals and otomycosis: a review. International Journal of Pediatric Otorhinolaryngology 2008; 72; 453-459.}and Oticara has observed that patients frequently have infections with both bacterial and fungal components.^{[10]10.Clinical observation by Oticara from clinical study OT-002}Unfortunately, misdiagnosis of fungal based infections and use of infective antibiotic treatments has been linked to an increase in the prevalence of fungal based ear infections.^{[11]11.A. Jackman, R. Ward, M. April, J. Bent, Topical antibiotic induced otomycosis, Int J Pediatr Otorhinolaryngol 69 (2005) 857—860.}Oticara’s patented, one time, in office treatment has demonstrated the potential to effectively treat infections, which are suspected or confirmed to be fungal in nature, by quickly resolving symptoms and eliminating the infection regardless if bacteria and/or fungus is present.^{[10]10.Clinical observation by Oticara from clinical study OT-002}