PMID- 31884564
OWN - NLM
STAT- MEDLINE
DCOM- 20201001
LR  - 20210110
IS  - 1179-1950 (Electronic)
IS  - 0012-6667 (Print)
IS  - 0012-6667 (Linking)
VI  - 80
IP  - 2
DP  - 2020 Feb
TI  - 24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant 
      (Bimatoprost SR) in Glaucoma Patients.
PG  - 167-179
LID - 10.1007/s40265-019-01248-0 [doi]
AB  - OBJECTIVE: The objective of this study was to evaluate the safety and intraocular 
      pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost 
      sustained-release implant (Bimatoprost SR) administration versus topical 
      bimatoprost 0.03% in patients with open-angle glaucoma (OAG). METHODS: This was a 
      phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical 
      trial. At baseline following washout, adult patients with OAG (N = 75) received 
      Bimatoprost SR (6, 10, 15, or 20 microg) intracamerally in the study eye; the fellow 
      eye received topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering 
      medication or single repeat administration with implant was permitted. The 
      primary endpoint was IOP change from baseline. Safety measures included adverse 
      events (AEs). RESULTS: At month 24, mean IOP reduction from baseline was 7.5, 
      7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 microg, 
      respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled 
      study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. 
      AEs in study eyes that occurred </= 2 days post-procedure typically were transient. 
      After 2 days post-procedure, overall AE incidence was similar between study and 
      fellow eyes, with some events typically associated with topical prostaglandin 
      analogs having lower incidence in study eyes. CONCLUSIONS: Bimatoprost SR showed 
      favorable efficacy and safety profiles up to 24 months, with all evaluated dose 
      strengths demonstrating overall IOP-reducing effects comparable to those of 
      topical bimatoprost. Targeted and sustained delivery of bimatoprost resulted in 
      protracted IOP lowering, suggesting that Bimatoprost SR may represent a 
      transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: 
      NCT01157364.
FAU - Craven, E Randy
AU  - Craven ER
AUID- ORCID: 0000-0002-2077-659X
AD  - Johns Hopkins University School of Medicine, 600 N. Wolfe Street, 110, Baltimore, 
      MD, 21287, USA. erandycraven@gmail.com.
FAU - Walters, Thomas
AU  - Walters T
AD  - Keystone Research, Ltd, Austin, TX, USA.
FAU - Christie, William C
AU  - Christie WC
AD  - Scott & Christie and Associates, Pittsburgh, PA, USA.
FAU - Day, Douglas G
AU  - Day DG
AD  - Coastal Research Associates, Roswell, GA, USA.
FAU - Lewis, Richard A
AU  - Lewis RA
AD  - Sacramento Eye Consultants, Sacramento, CA, USA.
FAU - Goodkin, Margot L
AU  - Goodkin ML
AD  - Allergan plc, Irvine, CA, USA.
FAU - Chen, Michelle
AU  - Chen M
AD  - Allergan plc, Irvine, CA, USA.
FAU - Wangsadipura, Veronica
AU  - Wangsadipura V
AD  - Allergan plc, Irvine, CA, USA.
FAU - Robinson, Michael R
AU  - Robinson MR
AD  - Allergan plc, Irvine, CA, USA.
FAU - Bejanian, Marina
AU  - Bejanian M
AD  - Allergan plc, Irvine, CA, USA.
CN  - Bimatoprost SR Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT01157364
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PL  - New Zealand
TA  - Drugs
JT  - Drugs
JID - 7600076
RN  - 0 (Antihypertensive Agents)
RN  - QXS94885MZ (Bimatoprost)
SB  - IM
MH  - *Absorbable Implants
MH  - Aged
MH  - Antihypertensive Agents/*administration & dosage/adverse effects/*therapeutic use
MH  - Bimatoprost/*administration & dosage/adverse effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Glaucoma/diagnosis/*drug therapy
MH  - Humans
MH  - Injections, Intraocular
MH  - Intraocular Pressure/drug effects
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC7007425
COIS- E. Randy Craven is a consultant for Aerie, Alcon, Allergan, Ivantis, Santen, and 
      WL Gore and has received grant support from Allergan. Thomas Walters is a 
      consultant for Allergan, Nicox, Ocular Therapeutix, and Sun. William C. Christie 
      is a consultant for Allergan and Johnson & Johnson. Douglas G. Day is a 
      consultant for Allergan. Richard A. Lewis is a consultant for Aerie, Alcon, 
      Allergan, Aquesys, AVS, Envisia, Glaukos, Ivantis, Oculeve, PolyActiva, ViSci, 
      and Zeiss. Margot L. Goodkin, Michelle Chen, Veronica Wangsadipura, Michael R. 
      Robinson, and Marina Bejanian are Allergan employees.
FIR - Aung, Tin
IR  - Aung T
FIR - Beck, Allen D
IR  - Beck AD
FIR - Branch, James D
IR  - Branch JD
FIR - Christie, William C
IR  - Christie WC
FIR - Coote, Michael
IR  - Coote M
FIR - Crane, Charles J
IR  - Crane CJ
FIR - Craven, E Randy
IR  - Craven ER
FIR - Crichton, Andrew
IR  - Crichton A
FIR - Day, Douglas G
IR  - Day DG
FIR - Day, Steven
IR  - Day S
FIR - Durcan, F Jane
IR  - Durcan FJ
FIR - Evans, Richard M
IR  - Evans RM
FIR - Flynn, William J
IR  - Flynn WJ
FIR - Gagne, Sebastien
IR  - Gagne S
FIR - Goldberg, Damien F
IR  - Goldberg DF
FIR - Greiner, Jack V
IR  - Greiner JV
FIR - Jeppsen, Paul
IR  - Jeppsen P
FIR - Jinapriya, Delan
IR  - Jinapriya D
FIR - Johnson, C Starck
IR  - Johnson CS
FIR - Kurtz, Shimon
IR  - Kurtz S
FIR - Lewis, Richard A
IR  - Lewis RA
FIR - Mansberger, Steven L
IR  - Mansberger SL
FIR - Martel, Joseph R
IR  - Martel JR
FIR - Perera, Shamira A
IR  - Perera SA
FIR - Rotberg, Michael H
IR  - Rotberg MH
FIR - Saltzmann, Robert M
IR  - Saltzmann RM
FIR - Schenker, Howard I
IR  - Schenker HI
FIR - Tepedino, Michael E
IR  - Tepedino ME
FIR - Yap-Veloso, Maria Imelda R
IR  - Yap-Veloso MIR
FIR - Uy, Harvey S
IR  - Uy HS
FIR - Walters, Thomas R
IR  - Walters TR
EDAT- 2019/12/31 06:00
MHDA- 2020/10/02 06:00
PMCR- 2019/12/28
CRDT- 2019/12/30 06:00
PHST- 2019/12/31 06:00 [pubmed]
PHST- 2020/10/02 06:00 [medline]
PHST- 2019/12/30 06:00 [entrez]
PHST- 2019/12/28 00:00 [pmc-release]
AID - 10.1007/s40265-019-01248-0 [pii]
AID - 1248 [pii]
AID - 10.1007/s40265-019-01248-0 [doi]
PST - ppublish
SO  - Drugs. 2020 Feb;80(2):167-179. doi: 10.1007/s40265-019-01248-0.