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

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 Disclosure(s)

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