Perfluorohexyloctane drops significantly improve dry eye due to Meibomian gland dysfunction

1. In a phase 3 randomized controlled trial of about 600 patients with dry eye disease, NOV03, a perfluorohexyloctane eye drop, was associated with significantly lower fluorescein staining on examination and self-reported dryness scores than saline drops at 8 weeks of treatment.

2. NOV03 was also associated with significant improvement compared to saline drops after 2 weeks of treatment based on both exam-based fluorescein scores and self-reported dryness scores.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Dry eye disease is an extremely common, multifactorial ocular condition that can cause irritation, blurred vision, and reduced quality of life. Meibomian gland dysfunction (MGD), deficiency or change in fatty secretions that form the tear film, contributes to most cases of dry eye disease. Currently, dry eye therapy is centered around artificial tears, warm compresses, and immune-directed eye drops that do not specifically target MGD. This phase 3 randomized trial including 597 patients aimed to assess the efficacy of NOV03, a perfluorohexyloctane eye drop that is thought to form a layer that preserves the tear film, in patients with MGD-associated dry eyes. Compared to patients using saline drops, patients using NOV03 had significantly lower fluorescein staining on exam by 0.97 points on a scale of 15, indicating improvement in dry eye, as well as self-reported improvement in dryness by 7.6 out of 100 points after 8 weeks of treatment. NOV03 was also associated with significantly greater improvement in both exam-based and self-reported scores than saline drops at both 2 week and 8 week timepoints. This trial provides convincing evidence of a modest but meaningful physiological and symptomatic benefit of this novel medication for patients with dry eye disease driven by MGD. The study included only patients with significant dry eye symptoms lasting at least 6 months and significant MGD based on exam, so further study in broader populations with dry eye symptoms will be necessary to determine which patients are likely to benefit.

Click to read the study in Ophthalmology

Relevant Reading: Modern approach to the treatment of dry eye, a complex multifactorial disease: A P.I.C.A.S.S.O. board review

In-Depth [randomized controlled trial]: Adults with symptomatic dry eye disease at 26 centers in the United States were included between 2019 and 2021. Among the inclusion criteria were tear break-up time of 5 seconds or less and MGD score above 3 on a scale from 0 to 15. The study was double-masked; patients in the control group received hypotonic saline drops. Patients did not use artificial tears or contact lenses during the trial. Subjects were randomized in a 1:1 ratio stratified by site and baseline dry eye severity. One drop of NOV03 or saline was used 4 times per day for 8 weeks. Fluorescein staining scores were based on physician rating on a scale from 0 to 3 at each of 5 corneal sites. The primary intention-to-treat analysis used hierarchical fixed testing on a predefined sequence of endpoints. At 8 weeks, the least-squares (LS) mean treatment difference in corneal fluorescein staining scores was -0.97 [95% confidence interval (CI) -1.40 to -0.55; p<0.001], and in dryness scores was -7.6 (95% CI -11.8 to -3.4; p<0.001). At 2 weeks, the LS mean treatment difference in fluorescein staining scores was -0.6 (95% CI -0.9 to -0.2; p=0.001) and in dryness scores was -4.7 (-8.2 to -1.2; p=0.009).

Image: PD

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