Bausch + Lomb Novaliq announce GOBI trial met both co-primary endpoints

Bausch + Lomb and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in class ocular therapeutics 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 DED associated with Meibomian gland dysfunction MGD . The U.S. Food and Drug Administration FDA assigned NOV03 a Prescription Drug User Fee Act PDUFA action date of June 28 . "NOV03 was specifically developed to address excess tear evaporation and alleviate the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction," said Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb. "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."1 DED is one of the most common ocular surface disorders, with MGD as a major cause of development and progression, affecting approximately nine out of 10 people with DED.2,3 DED due to MGD is caused by a deficient tear film lipid layer that leads to increased tear evaporation. There is currently no approved prescription eye drop in the United States indicated for DED associated with MGD. "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," said Christian Roesky, Ph.D., CEO, Novaliq. "We are pleased to be able to share these exciting findings in Ophthalmology, and 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."