Newly released research findings support a potential new treatment option for dry eye disease associated with meibomian gland dysfunction (MGD) that is distinct from anti-inflammatory and immunomodulatory agents, according to industry leaders.
Bausch + Lomb and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in class ocular therapeutics, yesterday announced that Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the pivotal Phase 3 trial GOBI, which is one of two pivotal Phase 3 trials for NOV03 (perfluorohexyloctane).
NOV03 is being investigated to treat the signs and symptoms of dry eye disease associated with MGD.
The US Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.
Ms Christina Ackermann, president of ophthalmic pharmaceuticals at Bausch + Lomb, said NOV03 was specifically developed to address excess tear evaporation and alleviate the signs and symptoms of dry eye disease associated with MGD.
“These findings reinforce NOV03 as a potential new treatment option that is distinct from anti-inflammatory and immunomodulatory agents. We are excited that the FDA is reviewing the New Drug Application for NOV03, which, if approved, would provide millions of patients with dry eye disease associated with meibomian gland dysfunction a prescription treatment option.”
Dry eye disease is one of the most common ocular surface disorders, with MGD a major cause of development and progression, affecting approximately nine out of 10 people with dry eye disease.
There is currently no approved prescription eye drop in the US indicated for dry eye disease associated with MGD, which is caused by a deficient tear film lipid layer that leads to increased tear evaporation.
Novaliq CEO Dr Christian Roesky said the company is pleased to be able to share these exciting findings in Ophthalmology.
“These data show that the GOBI trial met both co-primary endpoints and all key secondary endpoints, with statistical significance achieved in treating the signs and symptoms of dry eye disease associated with meibomian gland dysfunction as early as day 15,” he said.
“We look forward to our continued collaboration with Bausch + Lomb to hopefully bring NOV03 to market in the United States, and ultimately address an unmet medical need for those suffering with dry eye disease associated with meibomian gland dysfunction.”
Dr Yehia Hashad, executive vice president of research and development and chief medical officer at Bausch + Lomb said all of the patients in the study were required to meet specific criteria indicating presence of meibomian gland dysfunction.
“The findings of this study reinforce NOV03 as a potential treatment option for this patient population with unmet medical needs,” Hashad said.
The data from the Phase 3, multicenter, randomised, hypotonic saline-controlled, double masked GOBI study was based on results from 597 subjects aged 18 years and older who were randomised to either receive treatment with NOV03 four times daily or hypotonic saline solution four times daily (n=303 NOV03; n=294 saline).
The two primary endpoints were change from baseline at Week 8 (Day 57 ± 2) in total corneal fluorescein staining (tCFS) and eye dryness Visual Analog Scale (VAS) score. Key secondary endpoints included change from baseline in eye dryness VAS score and tCFS at Week 2 (Day 15 ± 1) and eye burning/stinging VAS score and central corneal fluorescein staining (cCFS) at Week 8. Significant improvements versus hypotonic saline solution were seen as early as day 15.
More reading
How dry eye can elevate your practice
Phase 2b results for Azura Ophthalmics meibomian gland dysfunction therapy
Making dry eye work for your independent optometry practice
