AUG 22, 2014
NovaBay Pharmaceuticals, Inc., 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 company does not plan to initiate any new studies of NVC-422 for this indication.
The trial was a global, multicentered, randomized study. The endpoints measured clearing of bulbar conjunctival injection, eradication of adenovirus from the tear film, spread of infection to the fellow eye, reduction in subepithelial infiltrates and clearing of blurred vision compared to vehicle at day 18. No significant adverse events were reported in the trial.
NovaBay plans to focus its resources on the commercial launch of its new i-Lid Cleanser and on the development and launch of other products.
“Demonstrating clinical benefit in patients with adenoviral conjunctivitis remains a significant challenge for the entire pharmaceutical industry,” said Dr. Ron Najafi, CEO of NovaBay. “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.”