June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
Topical ocular TRPV1 antagonist SAF312 was well tolerated and effectively reduced pain after photorefractive keratectomy (PRK)
Author Affiliations & Notes
  • Kalliopi Stasi
    Novartis Institute of Biomedical Research, Cambridge, Massachusetts, United States
  • Vance Thompson
    Vance Thompson Vision, Sioux Falls, South Dakota, United States
  • Majid Moshirfar
    Hoopes Vision Research Center, Draper, Utah, United States
  • Thomas Clinch
    Eye Doctors of Washington, Washington, United States
  • Stephen Scoper
    Virginia Eye Consultants, Norfolk, Virginia, United States
  • Steven Linn
    Hoopes Vision Research Center, Draper, Utah, United States
  • Avery McIntosh
    Novartis Institute of Biomedical Research, Cambridge, Massachusetts, United States
  • Yifang Li
    Novartis Institute of Biomedical Research, Cambridge, Massachusetts, United States
  • Matt Eaton
    Novartis Institute of Biomedical Research, Cambridge, Massachusetts, United States
  • Michela Montecchi Palmer
    Novartis Pharmaceuticals Inc, Fort Worth, Texas, United States
  • Sameena Haque
    Novartis Pharma AG, Basel, Basel-Stadt, Switzerland
  • Michael Ferriere
    Novartis Institute of Biomedical Research, Cambridge, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Kalliopi Stasi, Novartis (E); Vance Thompson, Acufocus, Alcon, Allergan, Allotex, Avellino, Avisi Technologies, Inc, Bausch and Lomb, BRIM Biotechnology, Inc, Carl Zeiss Meditec, Conjtac, CSO, Equinox, Euclid Systems, Expert Opinion, eyeBrain Medical Inc, Eyedetec, EyeGate Pharma, Forsight Robotics, Glaukos, Healthe, Imprimis, iVeena, Johnson and Johnson, Leica, Melt Pharmaceuticals, Mynosys, Novaliq, Ocular Innovations, OneFocus, OPHTEC, ORA, Oyster Point Pharma, Percept, Precision Lens, ReFocus, RxSight, SightSciences, Stuart Therapeutics, Tarsus Rx, TearClear, TherOptix, ThruFocus, Treehouse Health, Veracity, Viewpoint Therapeutics, Visant, Visiometrics, Vivior AG. (C), Acufocus, Alcon, Allergan, Bausch and Lomb, Carl Zeiss Meditec, Equinox, EyeGate Pharma, Glaukos, Johnson and Johnson, and ORA, RxSight, and SightSciences (F), Acufocus, Alcon, Glaukos, and Johnson and Johnson (R), Acufocus, Allotex, Avellino, Conjtac, Euclid Systems, Equinox, EyeGate Pharma, Expert Opinion, eyeBrain Medical Inc, Eyedetec, Forsight Robotics, Healthe, iVeena, Melt Pharmaceuticals, Mynosys, Ocular Innovations, Oyster Point Pharma, Percept, RxSight, SightSciences, Stuart Therapeutics, Tarsus Rx, TearClear, TherOptix, Treehouse Health, Veracity, Visant, and Vivior AG (I); Majid Moshirfar, None; Thomas Clinch, Novartis (F); Stephen Scoper, Alcon, Novartis (C); Steven Linn, None; Avery McIntosh, Novartis (E); Yifang Li, Novartis (E); Matt Eaton, Novartis (E); Michela Montecchi Palmer, Novartis (E); Sameena Haque, Novartis (E); Michael Ferriere, Novartis (E)
  • Footnotes
    Support  This study is sponsored by Novartis Pharmaceuticals.
Investigative Ophthalmology & Visual Science June 2021, Vol.62, 967. doi:
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      Kalliopi Stasi, Vance Thompson, Majid Moshirfar, Thomas Clinch, Stephen Scoper, Steven Linn, Avery McIntosh, Yifang Li, Matt Eaton, Michela Montecchi Palmer, Sameena Haque, Michael Ferriere; Topical ocular TRPV1 antagonist SAF312 was well tolerated and effectively reduced pain after photorefractive keratectomy (PRK). Invest. Ophthalmol. Vis. Sci. 2021;62(8):967.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : SAF312 is a potent inhibitor of the transient receptor potential cation channel subfamily V member 1 (TRPV1). This Phase 2a study (NCT02961062) evaluated the safety and efficacy of topical ocular SAF312 in post-PRK ocular pain.

Methods : Patients (pts) aged 18-75 years and eligible for PRK with myopia ≤−4.00 D sphere, ≤−4.50 D spherical equivalent, and astigmatism ≤3.00 D were allowed in this double-masked, vehicle-controlled, multicenter study. Pts were randomized (1:1) to 2 treatment sequences in a bilateral PRK crossover design (SAF312 2.5% followed by vehicle [or vice versa], 1 drop, 4× daily for 72 h post-PRK; Fig 1). The primary endpoints were visual analog scale (VAS) pain severity scores at 6 h and average VAS scores over 0-12 h postoperatively (postop). Incidence of oral rescue medication (ORM) use, wound healing rate, conjunctival hyperemia, and safety were assessed. P≤0.10 was deemed statistically significant (per primary endpoint power calculation).

Results : All 40 pts (mean±SD age: 34±9.8 years) completed the study. Both primary endpoints were met; difference between SAF312-treated (n=30) and vehicle-treated (n=29) eyes in mean VAS pain scores at 6 h postop was −11.1 (−25%) (90% CI: −17.54, −4.71; P=0.005), and at 0-12 h postop was −8.56 (−22%) (90% CI: −14.29, −2.83; P=0.017). The mean VAS pain scores were lower with SAF312 than with vehicle from 1 h postop (-53%) up to 30 h postop (P≤0.10 in 8/11 timepoints). Less ORM (number of pills) was taken with SAF312 (n=40) vs vehicle (n=40) at 0-6 h postop (−25%, P=0.10), and up to 0-72 h postop (−14%, P=0.07), with a trend of fewer pts needing any ORM at 0-24 h postop with SAF312 (40%) vs vehicle (30%). No delay in wound healing was noted in SAF312- vs vehicle-treated eyes. Grade 4 conjunctival hyperemia 24 h postop was significantly lower in SAF312- vs vehicle-treated eyes, especially in the superior conjunctiva associated with most surgical manipulation (P=0.04). No deaths or serious adverse events (AEs) were reported. Of the 40 pts in this study, 8 and 5 had AEs while on SAF312 and vehicle, respectively; and all ocular AEs (3 in each group) were mild and transient. No AE was drug-related.

Conclusions : Topical SAF312 was well tolerated and effective in reducing ocular pain in the immediate post-PRK period. SAF312 is currently under evaluation for postop corneal induced chronic pain (NCT04630158).

This is a 2021 ARVO Annual Meeting abstract.

 

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