June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
Phase 1 Study of OcuRing-K™ (Ketorolac Ophthalmic Implant) in Subjects Undergoing Cataract Surgery
Author Affiliations & Notes
  • Kenneth J Mandell
    LayerBio, Inc., Lexington, Massachusetts, United States
  • John D Sheppard
    Virginia Eye Consultants, Norfolk, Virginia, United States
  • Iqbal Ike K. Ahmed
    Prism Eye Institute, Ontario, Canada
  • Richard L. Lindstrom
    Minnesota Eye Consultants, Minneapolis, Minnesota, United States
  • Ehsan Sadri
    Visionary Eye Institute, Newport Beach, California, United States
  • Farrell Tyson
    Tyson Eye, Naples, Florida, United States
  • Roberto Gonzalez-Salinas
    Asociación para Evitar la Ceguera en México, Mexico City, Mexico
  • Footnotes
    Commercial Relationships   Kenneth Mandell, Layerbio, Inc. (E), Layerbio, Inc. (P); John Sheppard, Layerbio, Inc. (C), Layerbio, Inc. (I); Iqbal Ike Ahmed, Layerbio, Inc. (C); Richard Lindstrom, Layerbio, Inc. (C); Ehsan Sadri, Layerbio, Inc. (C); Farrell Tyson, Layerbio, Inc. (C); Roberto Gonzalez-Salinas, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2021, Vol.62, 573. doi:
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      Kenneth J Mandell, John D Sheppard, Iqbal Ike K. Ahmed, Richard L. Lindstrom, Ehsan Sadri, Farrell Tyson, Roberto Gonzalez-Salinas; Phase 1 Study of OcuRing-K™ (Ketorolac Ophthalmic Implant) in Subjects Undergoing Cataract Surgery. Invest. Ophthalmol. Vis. Sci. 2021;62(8):573.

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

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Purpose : Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are effective for the treatment of postoperative inflammation but have known limitations with respect to their tolerability and safety. Caution is recommended in patients with dry eye disease, diabetes, and systemic immunologic disorders due to an increased risk of corneal complications. There is a need for alternative delivery mechanisms that overcome the limitations of topical NSAIDs. Here we report the first clinical results with a novel sustained-release ketorolac implant in subjects undergoing cataract surgery.

Methods : A Phase 1, open-label study was conducted to assess the safety and efficacy of OcuRing-K™ (ketorolac ophthalmic implant) for treatment of postoperative inflammation after cataract surgery. Five subjects underwent cataract extraction with intraocular lens (IOL) implantation. Prior to IOL insertion, the OcuRing-K™ was applied to one haptic of the IOL, which was then inserted into the capsular bag using the standard surgical technique. No additional anti-inflammatory medications were administered. Subjects were evaluated postoperatively 1, 7, and 28 days after surgery. Inflammation was assessed by anterior chamber cell (ACC) score using the SUN scale. Postoperative pain was assessed using a visual analog scale (VAS).

Results : OcuRing-K™ was successfully implanted in five subjects without complication. In all five subjects, IOLs were observed to be centered on the visual axis without tilt, and OcuRing-K™ implants were visualized in their proper position on the IOL haptic at all visits. The mean postoperative ACC scores were 0.6 and 0.4 at days 1 and 7, respectively, and no ACC was observed in any subjects by day 28. All subjects were pain-free at days 1, 7, and 28. No treatment-related adverse events were reported. No subjects required rescue therapy with topical anti-inflammatory medication.

Conclusions : These results represent the first evidence of the safety and efficacy of OcuRing-K™ for use in cataract surgery. Although this was an open-label study with no comparators, the minimal inflammation observed and absence of pain among all subjects are highly consistent with the known anti-inflammatory and analgesic properties of ketorolac. These findings support the potential of the OcuRing-K™ implant as a safe and effective alternative to NSAID eye drops for use in cataract surgery.

This is a 2021 ARVO Annual Meeting abstract.


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