Alcon, Inc and its partner, NovaBay Pharmaceuticals, Inc, announced that Alcon has begun treating patients in a phase-2 clinical trial of NovaBay's patented lead Aganocide compound, NVC-422, for viral conjunctivitis, a type of 'pink eye'. Conjunctivitis is a pervasive and painful condition that affects both adults and children, leading to more than four million doctor and emergency room visits in the United States each year.

NovaBay has a licensing and research collaboration agreement with Alcon, the world's leading eye-care company, for use of its Aganocide compounds in the eye, ear and sinus, and in contact lens solutions.

Developed by NovaBay to mimic the body's defense against infection, Aganocides are proprietary synthetic analogs of the same molecules used by white blood cells to destroy harmful microbes in the body, such as viruses and bacteria. Because of their natural mechanism of action, NovaBay believes that Aganocide compounds have a low potential for generating microbial resistance, offering a potential solution to the problem of rising resistance of microbes to traditional antibiotics.

The phase-2 viral conjunctivitis study follows a recently completed phase-1 trial in which safety and tolerability were successfully demonstrated in 120 healthy volunteers with no reported serious adverse events.

"We are pleased to be entering mid-stage clinical testing for viral conjunctivitis," said Ron Najafi, chairman and chief executive officer of NovaBay. "This is the first step in the ophthalmic clinical development programme for NVC-422, which has the immediate goal of developing the first effective product to address viral conjunctivitis for which there are limited treatment options."

The phase-2 multi-center, randomized, placebo-controlled trial is designed to determine the safety and efficacy of NVC-422 in people with viral conjunctivitis. The study calls for enrolling approximately 250 patients at more than 30 medical centers, mostly in the United States.

"This study is an important step forward with the clinical program for this potentially dual-acting therapy to address the multiple causes of conjunctivitis. Dual action against viral and bacterial conjunctivitis is important because when an infection is diagnosed it is difficult, time-consuming and expensive to determine the underlying cause of the infection and treat it properly," said Dr Sabri Markabi, Alcon's senior vice president of research and development and chief medical officer.

The Aganocide compounds are novel, proprietary, synthetic N-chlorinated antimicrobial molecules specifically developed by NovaBay to mimic the body's natural defense against infection.

Alcon is the world's leading eye care company, with sales of approximately $6.3 billion in 2008. Alcon, which has been dedicated to the ophthalmic industry for more than 65 years, researches, develops, manufactures and markets pharmaceutical products, surgical equipment and devices, contact lens care solutions and other vision care products that treat diseases, disorders and other conditions of the eye.

NovaBay Pharma is a mid-stage biopharmaceutical company focused on developing its proprietary and patented Aganocide compounds, which are novel, synthetic anti-infective product candidates that are bioequivalent to the active antimicrobial molecules generated within white blood cells to treat and prevent a wide range of infections without causing bacterial resistance.