Abstract
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.