PMID- 34942112
OWN - NLM
STAT- MEDLINE
DCOM- 20220425
LR  - 20220510
IS  - 1879-1891 (Electronic)
IS  - 0002-9394 (Linking)
VI  - 237
DP  - 2022 May
TI  - Periocular Adverse Reactions to Omidenepag Isopropyl.
PG  - 114-121
LID - S0002-9394(21)00648-6 [pii]
LID - 10.1016/j.ajo.2021.12.011 [doi]
AB  - 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.
CI  - Copyright (c) 2021 Elsevier Inc. All rights reserved.
FAU - Inoue, Kenji
AU  - Inoue K
AD  - 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.
FAU - Shiokawa, Minako
AU  - Shiokawa M
AD  - From the Inouye Eye Hospital (K.In., M.S., S.K., M.T., G.T.), Tokyo, Japan.
FAU - Katakura, Seiki
AU  - Katakura S
AD  - From the Inouye Eye Hospital (K.In., M.S., S.K., M.T., G.T.), Tokyo, Japan.
FAU - Tsuruoka, Mieko
AU  - Tsuruoka M
AD  - From the Inouye Eye Hospital (K.In., M.S., S.K., M.T., G.T.), Tokyo, Japan.
FAU - Kunimatsu-Sanuki, Shiho
AU  - Kunimatsu-Sanuki S
AD  - Nishikasai Inouye Eye Hospital (S.K.-S.), Tokyo, Japan.
FAU - Shimizu, Kosuke
AU  - Shimizu K
AD  - Sapporo Inouye Eye Clinic (K.S.), Sapporo, Japan.
FAU - Ishida, Kyoko
AU  - Ishida K
AD  - Department of Ophthalmology, Toho University Ohashi Medical Center (K.Is., G.T.), 
      Tokyo, Japan.
FAU - Tomita, Goji
AU  - Tomita G
AD  - 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.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
DEP - 20211220
PL  - United States
TA  - Am J Ophthalmol
JT  - American journal of ophthalmology
JID - 0370500
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Pyrazoles)
RN  - 0 (Pyridines)
RN  - G0G0H52U6K (omidenepag isopropyl)
RN  - TE7660XO1C (Glycine)
SB  - IM
MH  - Antihypertensive Agents/adverse effects
MH  - *Glaucoma, Open-Angle
MH  - Glycine/analogs & derivatives
MH  - Humans
MH  - Intraocular Pressure
MH  - *Ocular Hypertension
MH  - Pyrazoles/therapeutic use
MH  - Pyridines
EDAT- 2021/12/24 06:00
MHDA- 2022/04/26 06:00
CRDT- 2021/12/23 20:11
PHST- 2021/08/11 00:00 [received]
PHST- 2021/12/07 00:00 [revised]
PHST- 2021/12/08 00:00 [accepted]
PHST- 2021/12/24 06:00 [pubmed]
PHST- 2022/04/26 06:00 [medline]
PHST- 2021/12/23 20:11 [entrez]
AID - S0002-9394(21)00648-6 [pii]
AID - 10.1016/j.ajo.2021.12.011 [doi]
PST - ppublish
SO  - Am J Ophthalmol. 2022 May;237:114-121. doi: 10.1016/j.ajo.2021.12.011. Epub 2021 
      Dec 20.