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. 2025 Apr 25;5(5):100806.
doi: 10.1016/j.xops.2025.100806. eCollection 2025 Sep-Oct.

Double-Masked, Dose-Response, Vehicle-Controlled Study of VVN461 Ophthalmic Solution in Postoperative Ocular Inflammation

James H Peace  1 , Kevin Y Jong  2 , Jason Bacharach  3 , Xiao-Yan Li  4 , Wang Shen  4 , Caroline Lu  4 , Gary D Novack  5   6
Affiliations

Double-Masked, Dose-Response, Vehicle-Controlled Study of VVN461 Ophthalmic Solution in Postoperative Ocular Inflammation

James H Peace et al. Ophthalmol Sci. .

Abstract

Purpose: To evaluate the safety and ocular efficacy of VVN461, a Janus kinase kinase inhibitor, for treatment of postoperative inflammation.

Design: This was a phase II, multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study in subjects who underwent routine unilateral cataract extraction and lens replacement surgery via phacoemulsification without surgical complication.

Participants: Ninety-one subjects at 9 private practice US ophthalmology offices.

Intervention: VVN61 0.5% and 1.0% topical ophthalmic solution or vehicle, 4 times daily.

Main outcome measures: The proportion of subjects with anterior chamber cell (ACC) grade 0 in the study eye at day 14.

Results: The proportion of subjects with ACC grade 0 in the study eye at day 14 was 60.0% (18/30), 53.3% (16/30), and 19.4% (6/31) in the VVN461, 1.0%, VVN461, 0.5%, and vehicle groups, respectively (P = 0.0012 and 0.0057). Treatment effects in favor of VVN461 were also seen in the need for rescue medication and reduction of anterior chamber flare. There were relatively few adverse events in either VVN461 treatment group (10%, 3/30, or less), and they were judged of mild severity.

Conclusions: In this double-masked, vehicle-controlled study, clinically and statistically significant anti-inflammatory efficacy was seen with few safety issues.

Financial disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Keywords: Cataract surgery; Inflammation; JAK kinase; VVN461.

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Figures

Figure 1
Figure 1
Number of subjects with an anterior chamber cell score of 0 by visit. Each active group was statistically significantly different from the vehicle at both day 14 and day 28 (P < 0.01). N = 30 to 31 for each treatment group. P values for comparison of VVN461 1.0% and 0.5% to vehicle: day 3: 0.57 and 0.9729; day 7: 0.05 and 0.26; day 14: <0.01 and <0.01, respectively.
See this image and copyright information in PMC

References

    1. Kim T., Sall K., Holland E.J., et al. Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery. Clin Ophthalmol. 2019;13:69–86. - PMC - PubMed
    1. Wen J., Hu H., Chen M., et al. Role of Janus kinase (JAK) inhibitor in autoimmune ocular inflammation: a systematic Review. J Immunol Res. 2021;2021 - PMC - PubMed
    1. Jabs D.A., Nussenblatt R.B., Rosenbaum J.T. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005;140:509–516. - PMC - PubMed
    1. Robin A.L., Novack G.D., Covert D.W., et al. Adherence in glaucoma: objective measurements of once-daily and adjunctive medication use. Am J Ophthalmol. 2007;14:533–540. - PubMed
    1. Schwartz A. Efficacy and safety of Clobetasol propionate ophthalmic nanoemulsion, 0.05% for the treatment of intraocular inflammation and pain associated with cataract surgery. Invest Ophthalmol Vis Sci. 2023;64:3314.

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