Alcon, Inc. (NYSE: ACL)
and its partner, NovaBay Pharmaceuticals, Inc. (NYSE-AMEX: NBY),
announced today 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, Ph.D., chairman and chief executive
officer of NovaBay. “This is the first step in the ophthalmic clinical
development program 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.
