June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Two Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Studies of the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution 8% (AG-920)
Author Affiliations & Notes
  • Victor H Gonzalez
    Ophthalmology, Valley Retina Institute, McAllen, Texas, United States
    Molecular, The University of Texas Rio Grande Valley School of Medicine, Edinburg, Texas, United States
  • Gary D Novack
    Ophthalmology, University of California Davis, Davis, California, United States
  • David Wirta
    Ophthalmology, Eye Research institute, New Port Beach, California, United States
  • Martin Uram
    American Genomics, Little Silver, New Jersey, United States
  • Audrey Schupp
    CMC Turnkey solutions, Lone tree, Colorado, United States
  • Michelle C Widmann
    Cal Clinical Trials solution, Apex, North Carolina, United States
  • Footnotes
    Commercial Relationships   Victor Gonzalez Unity, Bausch and Lomb, American Genomics,, Code C (Consultant/Contractor), Genentech, Regeneron, Allergan, Alimera, Valeant, Bausch and Lomb, Santen, Iconic, Boehringer, insite, Topcon, Beaver-Visitec, Astellas, Opthea, 60 degree pharm, Apellis, RIBOMIC, Iveric, Nanoscope, Occuphire, Unity,, Code F (Financial Support); Gary Novack American Genomics, Code C (Consultant/Contractor); David Wirta American Genomics, Code C (Consultant/Contractor); Martin Uram American Genomics, Code C (Consultant/Contractor); Audrey Schupp American Genomics, Code C (Consultant/Contractor); Michelle Widmann American Genomics, Code C (Consultant/Contractor)
  • Footnotes
    Support  This study was supported by American Genomics.
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 334 – F0165. doi:
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      Victor H Gonzalez, Gary D Novack, David Wirta, Martin Uram, Audrey Schupp, Michelle C Widmann; Two Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Studies of the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution 8% (AG-920). Invest. Ophthalmol. Vis. Sci. 2022;63(7):334 – F0165.

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

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Purpose : We desired to develop a new topical ocular anesthetic with good bioavailability in anterior segment tissues. As well, given concerns about contamination and sterility in multi-dose products, we selected a unit-dose, non-preserved presentation in blow-fill-seal containers (similar to currently marketed pharmacological therapies for dry eye disease). The primary objective of these two Phase 3, randomized, placebo-controlled, double-masked, parallel design studies in healthy subjects was to evaluate anesthetic efficacy of AG-920. The secondary objectives included and the safety and tolerability of AG-920.

Methods : In each study, 120 subjects were randomized to receive a single dose of AG-920 or identical looking placebo into one (study) eye (2 drops 30 seconds apart). Subjects underwent a conjunctival pinch procedure and the pain associated with the pinch assessed. A priori, the primary endpoint was “no pain at 5 minutes”.

Results : AG-920 provide a rapid onset of local anesthesia (less than one minute) with clinically and statistically significantly greater effect in AG-920 (68% and 83%) than placebo (3% and 18%, for Study 1 and Study 2, respectively, p < 0.0001). The most frequently adverse event was instillation site pain (27% vs 3%), followed by conjunctival hyperemia (probably related to the pinch, 9% vs 10%) in the AG-920 and placebo groups, respectively.

Conclusions : A single dose of AG-920 (two drops 30 seconds apart) resulted in local ocular anesthesia in a short period of less than half minute and lasting up to approximately 15 minutes or longer. Other than mild conjunctival hyperemia, there were no clinically significant safety findings.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.


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