Kenji Inoue1, Minako Shiokawa2, Seiki Katakura2, Mieko Tsuruoka2, Shiho Kunimatsu-Sanuki3, Kosuke Shimizu4, Kyoko Ishida5, Goji Tomita6. 1. From the Inouye Eye Hospital (K.In., M.S., S.K., M.T., G.T.), Tokyo, Japan. Electronic address: 2inoue-k@inouye-eye.or.jp. 2. From the Inouye Eye Hospital (K.In., M.S., S.K., M.T., G.T.), Tokyo, Japan. 3. Nishikasai Inouye Eye Hospital (S.K.-S.), Tokyo, Japan. 4. Sapporo Inouye Eye Clinic (K.S.), Sapporo, Japan. 5. Department of Ophthalmology, Toho University Ohashi Medical Center (K.Is., G.T.), Tokyo, Japan. 6. From the Inouye Eye Hospital (K.In., M.S., S.K., M.T., G.T.), Tokyo, Japan; Department of Ophthalmology, Toho University Ohashi Medical Center (K.Is., G.T.), Tokyo, Japan.
Abstract
PURPOSE: To investigate the periocular adverse reactions to omidenepag isopropyl (OMDI). DESIGN: Nonrandomized comparative clinical study. METHODS: We enrolled 100 patients (100 eyes) with primary open-angle glaucoma or ocular hypertension who received initial treatment with OMDI or tafluprost in only 1 eye for ≥6 months. Photographs of the eyelids were taken on the day of the participants' visit after ≥6 months of prescription. Subsequently, 3 ophthalmologists individually determined the occurrence of eyelid pigmentation, eyelash growth, and deepening of the upper eyelid sulcus (DUES). Additionally, a questionnaire on the subjective symptoms was administered. Multivariate analysis of baseline data was performed to investigate the factors involved in adverse reactions. RESULTS: The mean duration of drug administration was 10.2 ± 3.8 and 10.8 ± 4.1 months in the OMDI and tafluprost groups, respectively. The frequencies of eyelid pigmentation, eyelash growth, and DUES were 0.0%, 0.0%, and 2.0%, respectively, in the OMDI group, whereas the corresponding values in the tafluprost group were 4.0%, 32.0%, and 12.0%. The only significant difference was that the OMDI group showed fewer patients with eyelash growth than in the tafluprost group (P < .0001). In the questionnaire, the subjective symptoms of eyelid pigmentation, eyelash growth, and DUES were 8.0%, 2.0%, and 4.0%, respectively, in the OMDI group, whereas the corresponding values in the tafluprost group were 12.0%, 40.0%, and 4.0%, respectively. Multivariate analysis revealed a correlation between the type of drug administered and these adverse reactions (R = 0.38, P = .005). CONCLUSIONS: The frequencies of periocular adverse reactions to OMDI, ranging from 0% to 2.0%, were lower than those to tafluprost.
PURPOSE: To investigate the periocular adverse reactions to omidenepag isopropyl (OMDI). DESIGN: Nonrandomized comparative clinical study. METHODS: We enrolled 100 patients (100 eyes) with primary open-angle glaucoma or ocular hypertension who received initial treatment with OMDI or tafluprost in only 1 eye for ≥6 months. Photographs of the eyelids were taken on the day of the participants' visit after ≥6 months of prescription. Subsequently, 3 ophthalmologists individually determined the occurrence of eyelid pigmentation, eyelash growth, and deepening of the upper eyelid sulcus (DUES). Additionally, a questionnaire on the subjective symptoms was administered. Multivariate analysis of baseline data was performed to investigate the factors involved in adverse reactions. RESULTS: The mean duration of drug administration was 10.2 ± 3.8 and 10.8 ± 4.1 months in the OMDI and tafluprost groups, respectively. The frequencies of eyelid pigmentation, eyelash growth, and DUES were 0.0%, 0.0%, and 2.0%, respectively, in the OMDI group, whereas the corresponding values in the tafluprost group were 4.0%, 32.0%, and 12.0%. The only significant difference was that the OMDI group showed fewer patients with eyelash growth than in the tafluprost group (P < .0001). In the questionnaire, the subjective symptoms of eyelid pigmentation, eyelash growth, and DUES were 8.0%, 2.0%, and 4.0%, respectively, in the OMDI group, whereas the corresponding values in the tafluprost group were 12.0%, 40.0%, and 4.0%, respectively. Multivariate analysis revealed a correlation between the type of drug administered and these adverse reactions (R = 0.38, P = .005). CONCLUSIONS: The frequencies of periocular adverse reactions to OMDI, ranging from 0% to 2.0%, were lower than those to tafluprost.