NovaBay Pharmaceuticals, Inc., announced that it has enrolled the first patients in its global phase 2b clinical study. The study (BAYnovation) will evaluate the company's lead compound, NVC-422, for treating adenoviral conjunctivitis, a highly contagious form of pink eye.
After providing certain suggestions and insight into the design of BAYnovation at an end-of-phase 2A meeting, the Food and Drug Administration (FDA) confirmed that the trial has all the design elements (controls, sample size, end-points) of a pivotal trial.
"We are very pleased with the guidance that we have received from the FDA and we are excited to launch BAYnovation as a global clinical trial to develop a treatment for adenoviral conjunctivitis," said Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay. "We believe the FDA recognizes the need for a well-tolerated, topically administered therapy in this indication, as there is no current treatment for viral conjunctivitis. We look forward to continuing clinical development of NVC-422 and working closely with the FDA to ensure this product reaches the market as quickly as possible."
"Viral conjunctivitis remains the largest untreated ocular infection globally," commented Dr. David Stroman, PhD, Senior Vice President, Ophthalmology at NovaBay Pharmaceuticals. "I am personally thrilled that patient enrollment has begun in this new conjunctivitis study, the design of which was based on the important clinical findings seen in the previous study of NVC-422. NovaBay is committed to providing a novel therapeutic solution for the millions of Americans and people around the world who suffer from this highly contagious ocular infection every year."
Previously, NovaBay reported very encouraging data from its Phase 2a clinical study, which suggested that NVC-422 may be efficacious in patients infected with adenoviral serotypes associated with epidemic keratoconjunctivitis (EKC), the most highly contagious and potentially sight-threatening form of adenoviral conjunctivitis.