PMID- 34495425
OWN - NLM
STAT- MEDLINE
DCOM- 20211026
LR  - 20220531
IS  - 1613-2246 (Electronic)
IS  - 0021-5155 (Linking)
VI  - 65
IP  - 6
DP  - 2021 Nov
TI  - Twelve-month efficacy and safety of omidenepag isopropyl, a selective EP2 
      agonist, in open-angle glaucoma and ocular hypertension: the RENGE study.
PG  - 810-819
LID - 10.1007/s10384-021-00868-y [doi]
AB  - PURPOSE: To assess the long-term safety and efficacy of omidenepag isopropyl 
      (OMDI) 0.002% (a first-in-class, selective, non-prostaglandin, prostanoid EP2 
      receptor agonist), alone or administered concomitantly with timolol 0.5%, in 
      patients with open-angle glaucoma (OAG, including normal-tension and exfoliation 
      glaucoma) or ocular hypertension (OHT). STUDY DESIGN: Open-label, multicenter, 
      Phase 3 study (NCT02822729). METHODS: Patients aged >/= 20 years, with OAG or OHT, 
      and a baseline diurnal intraocular pressure (IOP) >/= 16- < 22 mmHg (Group 1) 
      or >/= 22- </= 34 mmHg (Groups 2 and 3) were enrolled. All patients (N = 125) 
      received OMDI 0.002% once daily. Group 3 also received timolol 0.5% twice daily. 
      IOP was measured at baseline and at Weeks 2, 4, 8, 12, 26, 40, and 52. RESULTS: 
      Significant reductions in mean diurnal IOP from baseline occurred at every visit 
      (P < 0.0001). Mean +/- SE diurnal IOP reduction at Week 52 was -3.7 +/- 0.3 mmHg 
      (Group 1), -5.6 +/- 0.5 mmHg (Group 2), and -8.4 +/- 0.6 mmHg (Group 3). Most adverse 
      events (AEs) were mild, and no serious treatment-related AEs were reported. 
      Conjunctival hyperemia (incidence: monotherapy [Groups 1 and 2], 18.8%; 
      concomitant [Group 3], 45.0%) and macular edema (ME)/cystoid macular edema (CME) 
      (incidence: monotherapy, 11.8%; concomitant, 15.0%) occurred most frequently. All 
      treatment-related ME/CME cases occurred in pseudophakic eyes and responded to 
      standard-of-care treatment and study drug discontinuation. CONCLUSIONS: In this 
      study, OMDI 0.002%, alone or administered concomitantly with timolol 0.5%, 
      resulted in sustained IOP reduction over 52 weeks in patients with OAG or OHT. 
      Concomitant treatment resulted in increased efficacy and increased incidence of 
      conjunctival hyperemia.
CI  - (c) 2021. Japanese Ophthalmological Society.
FAU - Aihara, Makoto
AU  - Aihara M
AD  - Ophthalmology, University of Tokyo, Tokyo, Japan.
FAU - Lu, Fenghe
AU  - Lu F
AD  - Santen Inc., 6401 Hollis Street, Suite 125, Emeryville, CA, 94608, USA. 
      Fenghe.Lu@santen.com.
FAU - Kawata, Hisashi
AU  - Kawata H
AD  - Santen Pharmaceutical Co., Ltd., Osaka, Japan.
FAU - Iwata, Akihiro
AU  - Iwata A
AD  - Santen Pharmaceutical Co., Ltd., Osaka, Japan.
FAU - Odani-Kawabata, Noriko
AU  - Odani-Kawabata N
AD  - Santen Inc., 6401 Hollis Street, Suite 125, Emeryville, CA, 94608, USA.
AD  - Santen Pharmaceutical Co., Ltd., Osaka, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT02822729
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
DEP - 20210908
PL  - Japan
TA  - Jpn J Ophthalmol
JT  - Japanese journal of ophthalmology
JID - 0044652
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Ophthalmic Solutions)
RN  - 0 (Pyrazoles)
RN  - 0 (Pyridines)
RN  - 817W3C6175 (Timolol)
RN  - G0G0H52U6K (omidenepag isopropyl)
RN  - TE7660XO1C (Glycine)
SB  - IM
MH  - Antihypertensive Agents/adverse effects
MH  - Double-Blind Method
MH  - *Glaucoma, Open-Angle/diagnosis/drug therapy
MH  - Glycine/analogs & derivatives
MH  - Humans
MH  - Intraocular Pressure
MH  - *Ocular Hypertension/drug therapy
MH  - Ophthalmic Solutions
MH  - Pyrazoles
MH  - Pyridines
MH  - Timolol/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - EP2 receptor agonist
OT  - Glaucoma
OT  - Ocular hypertension
OT  - Omidenepag isopropyl
OT  - Phase 3
EDAT- 2021/09/09 06:00
MHDA- 2021/10/27 06:00
CRDT- 2021/09/08 12:29
PHST- 2021/02/26 00:00 [received]
PHST- 2021/06/28 00:00 [accepted]
PHST- 2021/09/09 06:00 [pubmed]
PHST- 2021/10/27 06:00 [medline]
PHST- 2021/09/08 12:29 [entrez]
AID - 10.1007/s10384-021-00868-y [pii]
AID - 10.1007/s10384-021-00868-y [doi]
PST - ppublish
SO  - Jpn J Ophthalmol. 2021 Nov;65(6):810-819. doi: 10.1007/s10384-021-00868-y. Epub 
      2021 Sep 8.