NovaBay Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing its proprietary and patented Aganocide compounds, announced that its NVC-422 ophthalmic formulation did not meet the primary or secondary endpoints in a phase 2 clinical study in patients with adenoviral conjunctivitis.
The trial was a global, multi-centered, randomized study that enrolled patients with adenoviral conjunctivitis in the United States, India, Sri Lanka, and Brazil. The endpoints measured clearing of bulbar conjunctival injection (red eye), eradication of adenovirus from the tear film, spread of infection to the fellow eye, reduction in sub-epithelial infiltrates, clearing of blurred vision compared to its Vehicle at Test-of-Cure Visit (Day 18). No significant adverse events were reported in the trial.
NovaBay does not intend to initiate any new studies of NVC-422 for this indication. Going forward, the company is focusing its resources on: • The commercial launch of NovaBay’s new i-Lid Cleanser; • Supporting Pioneer Pharma in the commercial launch of NeutroPhase in China, pending China FDA approval; and • The clinical development of NVC-422 Irrigation Solution for blockage and encrustation in indwelling long-term urinary catheters.
“Demonstrating clinical benefit in patients with adenoviral conjunctivitis remains a significant challenge for the entire pharmaceutical industry. Our energies and resources in the future will be committed to supporting our sales force, which is now deployed across the United States supporting our i-Lid Cleanser launch,” said Dr Ron Najafi, CEO of NovaBay.