BUSINESS WIRE
Othera Pharmaceuticals, Inc., announced today the submission of an
Investigational New Drug (IND) application to the U.S. Food and Drug
Administration (FDA) for OT-730, an oculoselective beta-blocker, as a
potential treatment for glaucoma. A Phase 1-2 safety and efficacy trial
is planned for completion by the end of 2008.
OT-730 is a novel, internally developed next generation topical
beta-blocker designed to lower intra-ocular pressure (IOP), the leading
risk factor for developing glaucoma. Beta-blockers as a class are among
the most widely-prescribed drugs for glaucoma, but carry label warnings
regarding the potential for serious systemic side effects. In
preclinical animal studies, OT-730 demonstrated comparable IOP-lowering
efficacy and superior systemic safety to the most-prescribed ocular
beta-blocker, timolol maleate. OT-730 is by design an oculoselective
drug, having excellent beta-blocking activity in the eye, yet easily
metabolized into inert components upon entry into the bloodstream.
“We believe that OT-730 may represent a
significant advance in terms of patient safety in the treatment of
glaucoma,” commented Dr. Al Reaves, Sr. VP of
Clinical Development. “All of the current drug
therapies for glaucoma on the market today have side effects, some
potentially life-threatening. OT-730 has been specifically designed as a
prodrug to deliver a potent beta-blocker locally within the eye, but
then rapidly break down to inactive metabolites upon entry into the
systemic circulation. Our goal in clinical trials will be to compare its
IOP-lowering effect against timolol (the most-prescribed ocular
beta-blocker) and to determine its effects, if any, on cardiovascular
and pulmonary function. We believe that OT-730’s
unique safety profile could ultimately position it as a leading
monotherapy or in combination with other classes of drugs for use in
glaucoma patients.”
The study is a randomized, multi-center, investigator-masked, timolol-
and placebo-controlled, Phase 1-2 evaluation of the safety and efficacy
of OT-730 ophthalmic solution in reducing the intraocular pressure in
subjects with ocular hypertension or open-angle glaucoma. Subjects will
be randomized to placebo or 0.5% timolol maleate or 0.75% OT-730.
About Glaucoma
Glaucoma is a leading cause of blindness in the world today, affecting
more than 65 million people globally. A sight-threatening disease,
glaucoma can cause optic nerve damage, visual field loss and even
blindness when left untreated. Elevated IOP is considered one of the
leading risk factors for glaucoma, and beta-blockers have been
successfully used by ophthalmologists for thirty years as first-line or
combination therapy with other agents to lower IOP. According to
published IMS data, approximately 4 million prescriptions are written in
the U.S. each year for ophthalmic beta-blockers, primarily for timolol
in a variety of formulations and strengths.
About Othera Pharmaceuticals
Founded in 2002, Othera Pharmaceuticals, Inc. is a specialty
pharmaceutical company focused on developing novel, patient-administered
products for ophthalmic disease. In addition to OT-730, Othera is also
developing OT-551, a topically-dosed, novel, small molecule that
inhibits oxidative stress and disease-induced inflammation. The company
has completed enrollment of a Phase 2 clinical trial of OT-551 for the
treatment of an advanced form of dry age-related macular degeneration,
which is also termed geographic atrophy (GA). Dry AMD affects over 10
million people in the U.S. alone with no approved drug treatments.
For information please visit Othera's website at www.othera.com.