Perfluorohexyloctane eye drops for dry eye disease impresses in phase III trial

The novel NOV03 ophthalmic drop consisting of perfluorohexyloctane appears to help reduce both signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD), as shown in the results of the phase III MOJAVE study.

MOJAVE included 620 adult patients with a history of DED and signs of MGD. They were randomly assigned to treatment with either NOV03 (n=311) or hypotonic saline (0.6%; n=309) four times daily for 8 weeks.

The primary sign and symptom endpoints were changes in total corneal fluorescein staining (tCFS; National Eye Institute scale) and eye dryness score (0–100 visual analogue scale [VAS]), respectively, from baseline to the end of treatment.

At week 8, NOV03 produced significantly greater improvements than saline in both tCFS (least-squares (LS) mean treatment difference, –1.2, 95 percent confidence interval [CI], –1.7 to –0.8; p<0.001) and VAS dryness score (LS mean treatment difference, –10.2, 95 percent CI, –14.4 to –6.1; p<0.001). Significant between-group differences were seen as early as week 2.

NOV03 was well tolerated, with an adverse event profile comparable to that of saline. The frequency of ocular adverse events was 12.9 percent with NOV03 and 12.3 percent with saline. None of the participants experienced serious adverse events, and no adverse events led to treatment discontinuation.