Ansley John, Mair Eric A, Namini Hamid, Lu Chung H, LeBel Carl
1 Carolina Ear, Nose and Throat Clinic, Orangeburg, SC, USA.
2 Charlotte Eye, Ear, Nose, and Throat Associates, Charlotte, NC, USA.
Ann Otol Rhinol Laryngol. 2019 Jun;128(6):524-533. doi: 10.1177/0003489419830116. Epub 2019 Mar 2.
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.
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.
OTO-201 demonstrated a significant increase in CC compared with sham at day 8 (69.2% vs 46.1%, P < .001). Higher CC was also noted on day 4 ( P = .028), day 15 ( P < .001), and day 29 ( P < .001). A similar effect was observed in the pathogen-positive population. Single OTO-201 administration in the office setting was well tolerated by subjects.
In this study in subjects with acute otitis externa, a single administration of 12 mg OTO-201 to the external auditory canal demonstrated a significantly higher proportion of subjects with CC and bacterial eradication compared with sham starting on day 4 and on all other observation days through day 29, with no safety or tolerability concerns identified. OTO-201 is the first agent in a randomized phase 3 study to demonstrate the efficacy and safety of a single-dose, health care professional-administered topical antibiotic for the treatment of acute otitis externa.
OTO-201是一种环丙沙星耳用混悬液，先前已获美国食品药品监督管理局批准，用于治疗需要放置鼓膜造孔管的双侧中耳积液患儿。在这项3期、双盲、随机、前瞻性、假对照、多中心研究中，对单侧或双侧急性外耳道炎患者的外耳道给予单剂量OTO-201。
262名年龄在3至83岁之间的受试者被随机分组，260名受试者被纳入意向性分析人群：OTO-201组（0.2 mL，12 mg，n = 130）或假治疗组（空气注射，n = 130）。主要疗效指标是第8天的临床治愈（CC），由盲法评估者根据红斑、水肿、耳漏和压痛进行判断。对受试者进行28天的疗效和安全性监测。
与假治疗组相比，OTO-201在第8天的CC显著增加（69.2%对46.1%，P <.001）。在第4天（P =.028）、第15天（P <.001）和第29天（P <.001）也观察到更高的CC。在病原体阳性人群中观察到类似效果。受试者对在门诊环境中单次给予OTO-201耐受性良好。
在这项针对急性外耳道炎患者的研究中，与假治疗相比，对外耳道单次给予12 mg OTO-201后，从第4天到第29天的所有其他观察日，CC和细菌清除的受试者比例显著更高，且未发现安全性或耐受性问题。OTO-201是随机3期研究中首个证明单剂量、由医护人员给药的局部用抗生素治疗急性外耳道炎的有效性和安全性的药物。
