NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY) announced today 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.
The statements in this release regarding NovaBay’s intent not to initiate any new studies of NVC-422 for adenoviral conjunctivitis, and its intent on where it will focus its energies and resources in the future, are forward-looking statements, which are based upon the company’s current expectations, assumptions, estimates, projections and beliefs. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to difficulties or delays in the market acceptance of i-Lid Cleanser, the ability to obtain final approval from the China FDA, and unexpected adverse side effects or inadequate therapeutic efficacy of NVC-422 for a urology application. Other risks, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay’s latest Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading “Risk Factors.” The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.
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