Ophthalmic solution for adenoviral conjunctivitis shows positive results in phase 2 trial

EMERYVILLE, Calif. — NovaBay Pharmaceuticals announced positive results of a phase 2 clinical study that evaluated an ophthalmic solution in the treatment of adenoviral conjunctivitis, according to a company press release.

The multicenter, double-masked, parallel, randomized U.S. study included 452 patients who received either NVC-422 ophthalmic solution or placebo eight times a day for 10 days. Of the patients, 81 had adenoviral conjunctivitis.

Although the primary endpoint of "sustained microbiological success of 20% greater than placebo" was not met, 38% of patients infected with adenovirus associated with epidemic keratoconjunctivitis had positive results. Specifically, researchers observed a sustained clearing of blurred vision in all patients treated with NVC-422 when compared with placebo.

"As a 'proof-of-concept' study, this trial has successfully generated many important hypotheses as to the mechanism of action of the drug and its potential benefits for the treatment of viral conjunctivitis, a serious unmet medical need in ophthalmology. We were also very encouraged by the fact that the treatment was well-tolerated," Ron Najafi, PhD, chairman and CEO of NovaBay, said in the release.

The most common adverse event was eye irritation, which was mild to moderate and resolved without treatment, the release said.