Bausch + Lomb announces topline results for phase III trial of NOV03 to treat DED associated with MGD

Bausch + Lomb and Novaliq GmbH have announced statistically significant topline data from the first phase 3 trial (GOBI trial) analyzing the investigational drug NOV03 as a first-in-class eye drop to treat dry eye disease (DED) associated with meibomian gland dysfunction (MGD).

The GOBI trial included 597 participants — aged 18 years and older — who randomly received either treatment with NOV03 four times a day or were administered a placebo (saline solution) four times a day, according to a company news release.

Conducted at 26 locations around the U.S., the double-masked, saline-controlled study also included four pre-specified secondary endpoints, which all demonstrated statistical superiority over the placebo.¹

The GOBI trial also met both of its co-primary, according to a company news release. This included:

• A change from baseline in total corneal fluorescein staining (tCFS) that achieved statistical significance at day 15 [p-value = 0.001] (secondary endpoint), with continued results through day 57 (primary endpoint) compared to control [p-value < 0.001]
  
• A change from baseline in dryness score that achieved statistical significance at day 15 [p-value = 0.009] (secondary endpoint), with continued results through day 57 (primary endpoint) compared to control [p-value < 0.001], as rated on a visual analogue scale (VAS) ranging from 0-100 (0 = no discomfort; 100 = maximum discomfort).
  

Overall, NOV03 was well-tolerated, with instillation site reactions below 0.5%, the release reported. Treatment emergent adverse events (TEAEs) were not reported by more than 3% of participants in either treatment group.¹

The number of patients who also reported at least one ocular TEAE was close between the treatment control arms, respectively.

With no current pharmaceutical therapy available in the U.S. for the treatment of DED associated with MGD, the latest topline results are encouraging, said Yolande Barnard, vice president and general manager, U.S. Pharmaceuticals at Bausch + Lomb, in the news release.

“These outstanding topline results are very encouraging that we may be able to bring this first-in-class treatment option to market for the millions of patients who have dry eye disease associated with meibomian gland dysfunction,” Barnard said.

Novaliq CEO Christian Roesky, PhD, expressed similar thoughts on the study’s results.

“We are very pleased with both the robustness and consistency of the results demonstrated in the GOBI trial as they confirm all efficacy and safety results from the previous Phase 2 SEECASE trial,” he said in a statement.

The trial program also includes an ongoing second phase 3, multi-center, randomized, double-masked saline-controlled trial (MOJAVE study), as well as a multi-center, single-arm 12-month safety extension trial (KALAHARI study).

If positive, topline results from the MOJAVE study would allow for a filing to the U.S. FDA in 2022.

References

1. Bausch + Lomb. Bausch + Lomb announces statistically significant topline results from the first phase 3 trial of NOV03 (perfluorohexyloctane) in dry eye disease associated with meibomian gland dysfunction. Available at: https://www.bausch.com/our-company/recent-news/artmid/11336/articleid/665/04132021-tuesday. Accessed 4/13/21.