Investigational drug for dry eye disease scores high in phase III study
Treatment with the NOV03 (perfluorohexyloctane) ophthalmic drop is well tolerated and yields significant improvements in the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction, according to the results of a phase III study.
The study included 597 adult patients with a history of DED for ≥6 months, tear film breakup time ≤5 seconds, meibomian gland dysfunction score ≥3 (0-15 scale), Schirmer I test (without anaesthesia) score ≥5 mm, and total corneal fluorescein staining (tCFS) score ≥4 and ≤11 (0-15 National Eye Institute [NEI] scale).
The participants were randomized to apply either NOV03 (n=303) or hypotonic (0.6%) saline (n=294) eye drops four times daily for 8 weeks. The primary sign and symptom endpoints were change in tCFS and eye dryness score (0–100 visual analogue scale [VAS]) at week 8. Secondary endpoints were changes in eye dryness score at week 2, tCFS at week 2, eye burning/stinging score (0–100 VAS) at week 8, and central corneal fluorescein staining (cCFS; 0–3 NEI scale) at week 8.
Compared with saline, NOV03 was associated with significantly greater improvements in both the week-8 tCFS (mean difference, –0.97, 95 percent confidence interval [CI], –1.40 to –0.55; p<0.001) and VAS dryness score (mean difference, –7.6, 95 percent CI, –11.8 to –3.4; p<0.001).
All key secondary endpoints also showed significant differences, in favour of NOV03. The mean differences were –4.7 (95 percent CI, –8.2 to –1.2) for VAS dryness score at week 2, –0.6 (95 percent CI, –0.9 to –0.2) for tCFS at week 2, –5.5 (95 percent CI, –9.5 to –1.6) for VAS burning/stinging score at week 8, and –0.2 (95 percent CI, –0.4 to –0.1) for cCFS at week 8 (p<0.01 for all).
There were ocular adverse events reported, although most of them were mild in severity. None of the patients had serious ocular adverse events. One patient discontinued NOV03 due to eye irritation.