Purpose: To evaluate the occurrence of hyperemia with, and efficacy of, bimatoprost 0.01 % for patients in Korea previously treated for open-angle glaucoma (OAG; including normal tension glaucoma) or ocular hypertension (OHT). Methods: In this multicenter, observational study (Asia Pacific Patterns from Early Access of Lumigan 0.01 % in Korea; APPEAL Korea), patients with unachieved target intraocular pressure (IOP) despite previous treatment received bimatoprost 0.01 % daily for 12 weeks. The primary endpoint was incidence of hyperemia and its severity, graded using the standard 5-point photographic scale and grouped as “none to mild” and “moderate to severe”. Hyperemia shifts were reported. IOP and adverse events (AEs) were recorded. Results: Of 800 patients (intent-to-treat/safety population), 248 were switched from previous treatment to bimatoprost 0.01 % monotherapy. Hyperemia shifts from baseline at weeks 6 and 12 were unchanged (84.8, 89.8 %), improved (4.4, 4.8 %), or worsened (10.8, 5.4 %), respectively. The shift was significant at week 6 (P < 0.0001). Hyperemia did not worsen significantly in patients previously receiving a prostaglandin analog or prostamide (PGA/PSD). Baseline mean IOP ± SD was 17.0 ± 5.7 mmHg, decreasing to 14.6 ± 3.8 mmHg (P < 0.0001) after 6 weeks, and to 14.7 ± 3.6 mmHg (P < 0.0001) after 12 weeks. Patients switched from PGA or PSD (excluding bimatoprost 0.03 %) to bimatoprost 0.01 % experienced significant IOP reductions from baseline. Treatment-related ocular AEs were reported by 37 patients, the most common being hyperemia (7.3 %). Conclusions: This subanalysis of the APPEAL Korea study supports use of bimatoprost 0.01 % for previously treated patients with OAG (including normal tension glaucoma) or OHT who did not reach target IOP or were intolerant of previous treatment.
Bibliographical noteFunding Information:
Writing and editorial assistance was provided to the authors by Paul Littlebury, PhD, and Gayle Scott, PharmD, of Evidence Scientific Solutions, and funded by Allergan, Inc., Irvine, CA. USA. Study Group Investigators: We acknowledge the following institutions (Researchers) for their participation in the study: Seoul National University Hospital (Ki Ho Park, Jin Wook Jeoung), Korea University Anam Hospital (Chungkwon Yoo), Seoul St. Mary’s Hospital (Chan Kee Park), Yeoeuido St. Mary’s Hospital (Myoung-Hee Park), Ewha Women’s University Mokdong Hospital (Ku Ryong Choi), Boramae Medical Center (Seok Hwan Kim), Severance Hospital (Chan Yun Kim), Chonnam National University Hospital (Sang Woo Park), Dongsan Medical Center (Yu Cheol Kim), Ulsan University Hospital (Jin Ho Yim), Kim’s Eye Hospital (Yong Ho Sohn), Siloam Eye Hospital (Ji Hyun Kim), Cheil Eye Hospital (Kyoo Won Lee), Busan National University Hospital (Ji Woong Lee), Asan Medical Center (Michael Scott Kook, Kyung Rim Sung), Ajou University Hospital (Jae Hong Ahn), Nune Eye Hospital (Young Jae Hong), Daegu Fatima Hospital (Dae Jin Park), Hangil Medical Foundation (Yeon-deok Kim, Jin Young Choi, Yun Suk Chung), Dong-A University Medical Center (Sae Heun Rho), Inje University Busan Paik Hospital (Jung Lim Kim), Gyeongsang National University Hospital (Seong-Jae Kim), Soon Chun Hyang University Hospital (Seung Joo Ha), Kong Eye Center (Won Hyuk Oh), Good Morning St. Mary’s Eye Center (Seung Youn Jae), Inje University Sanggye Hospital (Joo Hwa Lee), Nune Eye Hospital (Daegu) (Yong-Chul Park), Eulji University Seoul Eulji Hospital (Hyun Joo Lee), and Yeungnam University Medical Center (Soon Cheol Cha).
© 2015, Japanese Ophthalmological Society.
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