Pursuing FDA registration, researchers behind the phase-3 ‘Gobi’ trial of NOV03 (perfluorohexyloctane) eye drops to treat the symptoms of dry eye disease (DED) have reported positive outcomes by day 15 of treatment.
Developed by Bausch + Lomb and biopharmaceutical company Novaliq, and distributed in Australia and New Zealand by AFT Pharmaceuticals under the brand name NovaTears, NOV03 targets meibomian gland dysfunction (MGD). Its first US phase 3 trial included 597 participants who were randomised to receive saline placebo or NOV03 drops four times daily. Primary endpoints were met, including a change from baseline in total corneal fluorescein staining (tCFS), which achieved statistical significance at day 15, with continued results through to day 57 compared with the control group. The change in the patient’s dryness score from baseline also achieved statistical significance by day 15, with continued results through to day 57, as rated on a visual analogue scale (VAS) ranging from 0-100 (0 = no discomfort; 100 = maximum discomfort). The Gobi trial also met all of its secondary endpoints, showing statistically significant improvements in both the signs and symptoms of DED associated with MGD that were studied. Novaliq also reported that NOV03 was well tolerated by patients.
Joseph Papa, CEO of Bausch Health, said, “The rapid onset of action and statistical significance demonstrated in this trial is impressive. It also gets us a step closer to bringing forward this potential first-in-class treatment option, which could be a promising development for millions of patients.”
NOV03’s second phase-3 ‘Mojave’ trial began in November 2020; positive results will allow for a US Food and Drug Administration filing in 2022.
For more, see https://www.youtube.com/watch?v=tpYqOwZBI24