PMID- 36917119
OWN - NLM
STAT- MEDLINE
DCOM- 20230316
LR  - 20230328
IS  - 2164-2591 (Electronic)
IS  - 2164-2591 (Linking)
VI  - 12
IP  - 3
DP  - 2023 Mar 1
TI  - Topical Ocular TRPV1 Antagonist SAF312 (Libvatrep) for Postoperative Pain After 
      Photorefractive Keratectomy.
PG  - 7
LID - 10.1167/tvst.12.3.7 [doi]
LID - 7
AB  - PURPOSE: Evaluation of safety and efficacy of topical ocular SAF312 (Libvatrep) 
      in post-photorefractive keratectomy (PRK) pain. METHODS: In this placebo 
      (vehicle)-controlled, participant- and investigator-masked study, 40 participants 
      were randomized (1:1) to two treatment sequences in a bilateral PRK crossover 
      design (SAF312 2.5% followed by vehicle [or vice versa], one eye drop, four times 
      daily for 72 hours after PRK). Primary endpoints were visual analog scale (VAS) 
      pain scores at 6 hours after first drop of study drug and average VAS scores over 
      0 to 12 hours postoperatively. Secondary endpoints included postoperative oral 
      rescue medication (ORM) use and adverse events (AEs). RESULTS: All 40 
      participants completed the study. Both primary endpoints were met; mean 
      difference in VAS pain scores between SAF312- and vehicle-treated eyes was -11.13 
      (P = 0.005, -25%) at 6 hours postoperatively and -8.56 (P = 0.017, -22%) over 0 
      to 12 hours. Mean VAS pain scores with SAF312 were consistently lower than with 
      vehicle from 1 hour postoperatively up to 30 hours (P </= 0.10 observed in 8/11 
      time points). Less ORM was taken with SAF312 up to 0 to 72 hours postoperatively, 
      with a trend of fewer participants taking ORM at 0 to 24 hours postoperatively 
      with SAF312 versus vehicle. No serious AEs were reported. All ocular AEs were 
      mild and transient, and none were drug related. SAF312-treated eyes showed no 
      delay in wound healing and had a lower grade 4 conjunctival hyperemia 24 hours 
      postoperatively versus vehicle-treated eyes. CONCLUSIONS: SAF312 was well 
      tolerated and effective in reducing ocular pain post-PRK. TRANSLATIONAL 
      RELEVANCE: Topical SAF312 presents a new therapeutic option for patients 
      undergoing PRK.
FAU - Thompson, Vance
AU  - Thompson V
AD  - Vance Thompson Vision, Sioux Falls, SD, USA.
AD  - University of South Dakota, Sanford School of Medicine, Sioux Falls, SD, USA.
FAU - Moshirfar, Majid
AU  - Moshirfar M
AD  - Hoopes, Durrie, Rivera Research, Hoopes Vision, Draper, UT, USA.
FAU - Clinch, Thomas
AU  - Clinch T
AD  - Eye Doctors of Washington, Washington, DC, USA.
FAU - Scoper, Stephen
AU  - Scoper S
AD  - Virginia Eye Consultants, Norfolk, VA, USA.
FAU - Linn, Steven H
AU  - Linn SH
AD  - Hoopes, Durrie, Rivera Research, Hoopes Vision, Draper, UT, USA.
FAU - McIntosh, Avery
AU  - McIntosh A
AD  - Novartis Pharmaceuticals Corp., East Hanover, NJ, USA.
FAU - Li, Yifang
AU  - Li Y
AD  - Novartis Pharmaceuticals Corp., East Hanover, NJ, USA.
FAU - Eaton, Matt
AU  - Eaton M
AD  - Novartis Institute of Biomedical Research, Cambridge, MA, USA.
FAU - Ferriere, Michael
AU  - Ferriere M
AD  - Novartis Institute of Biomedical Research, Cambridge, MA, USA.
FAU - Stasi, Kalliopi
AU  - Stasi K
AD  - Novartis Institute of Biomedical Research, Cambridge, MA, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Transl Vis Sci Technol
JT  - Translational vision science & technology
JID - 101595919
RN  - 0 (TRPV1 protein, human)
RN  - 0 (TRPV Cation Channels)
SB  - IM
MH  - Humans
MH  - *Photorefractive Keratectomy/adverse effects
MH  - Pain, Postoperative/drug therapy/etiology/prevention & control
MH  - Wound Healing
MH  - TRPV Cation Channels/therapeutic use
PMC - PMC10020951
COIS- Disclosure: V. Thompson, BRIM Biotechnology Inc (C), CSO (C), Imprimis (C), Leica 
      (C), LensAR (C), ReFocus (C), Stepwise Medical (C), Thea (C), 2EyesVision (C), Al 
      Optics (O), Fontana Biosciences (O), Singular Strategies (O), Allotex (C, O), 
      Avellino (C, O), Avisi Technologies Inc (C, O), Conjtac (C, O), D&D 
      Biopharmaceuticals (C, O), Euclid Systems (C, O), Expert Opinion (C, O), eyeBrain 
      Medical Inc (C, O), Eyedetec (C, O), Eyesafe (C, O), FemtoVision (C, O), Forsight 
      Robotics (C, O), iVeena (C, O), Ocular Innovations (C, O), OneFocus (C, O), 
      Oyster Point Pharma (C, O), Percept (C, O), Stuart Therapeutics (C, O), Tarsus Rx 
      (C, O), TearClear (C, O), TearOptix (C, O), TherOptix (C, O), Treehouse Health 
      (C, O), Visant (C, O), Vivior AG (C, O), Ocular Therapeutix (C), Rayner (C), 
      Allergan (C), Bausch and Lomb (C), BVI (C), Carl Zeiss Meditec (C), ORA (C), 
      Alcon (C, F, R), Glaukos (C, F, R), Johnson and Johnson (C, F, R), Centricity (C, 
      F, O), Equinox (C, F, O), EyeGate Pharma (C, F, O), Melt Pharmaceuticals (C, F, 
      O), RxSight (C, F, O), SightSciences (C, F, O), Visus (C, F, O), Acufocus (C, F, 
      O, R); M. Moshirfar, None; T. Clinch, Novartis (F); S. Scoper, Alcon (C), 
      Novartis (C); S.H. Linn, None; A. Mcintosh, Novartis (E), Pfizer (E); Y. Li, 
      Novartis (E); M. Eaton, Novartis (E); M. Ferriere, Novartis (E); K. Stasi, 
      Novartis (E), Tenpoint Therapeutics (E)
EDAT- 2023/03/15 06:00
MHDA- 2023/03/17 06:00
PMCR- 2023/03/14
CRDT- 2023/03/14 11:33
PHST- 2023/03/14 11:33 [entrez]
PHST- 2023/03/15 06:00 [pubmed]
PHST- 2023/03/17 06:00 [medline]
PHST- 2023/03/14 00:00 [pmc-release]
AID - 2785441 [pii]
AID - TVST-22-4975 [pii]
AID - 10.1167/tvst.12.3.7 [doi]
PST - ppublish
SO  - Transl Vis Sci Technol. 2023 Mar 1;12(3):7. doi: 10.1167/tvst.12.3.7.