Recent U.S. FDA Approval of NDA Clears the Way for Commercialization
MADISON, N.J. and TIGARD, Ore., April 19, 2013 /PRNewswire/ — Bausch + Lomb, the global eye health company, and Paragon BioTeck, Inc. today announced that the companies have entered into a license agreement for Bausch + Lomb to commercialize and distribute Paragon’s phenylephrine in the United States on an exclusive basis beginning this month.
“This agreement with Paragon demonstrates Bausch + Lomb’s commitment to partnering with companies with eye health products that can benefit from our commercial capabilities,” said Dan Wechsler, president, Global Pharmaceuticals, Bausch + Lomb. “It is also an example of our on-going efforts to provide a comprehensive portfolio of eye health products to eye care practitioners and the patients they serve.”
“We are enthusiastic about embarking on this new relationship with Bausch + Lomb, as this level of collaboration is consistent with Paragon’s ongoing commitment to further develop and foster an unparalleled network of collaborative partners,” said Patrick H. Witham, president and chief executive officer, Paragon BioTeck, Inc.
About Phenylephrine Hydrochloride Ophthalmic Solution
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5 percent and 10 percent is an alpha-1 adrenergic receptor agonist used for dilation of the pupil due to its vasoconstrictor and mydriatic action. Phenylephrine possesses predominantly alpha-adrenergic effects. In the eye, phenylephrine acts locally as a potent vasoconstrictor and mydriatic by constricting ophthalmic blood vessels and the radial muscle of the iris.
Phenylephrine Hydrochloride Ophthalmic Solution Important Safety Information
Phenylephrine Hydrochloride Ophthalmic Solution, USP 10 percent is contraindicated in patients with hypertension or thyrotoxicosis, as well as in pediatric patients under the age of one due to the increased risk of systemic toxicity. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5 percent should be used in these patients. It’s for topical ophthalmic use only, and not for injection.
Serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, some fatal and significant elevations in blood pressure have been reported. Caution is advised in pediatric patients less than five years of age, and in patients with elevated blood pressure, cardiovascular disease or hyperthyroidism. Blood pressure should be monitored in patients with cardiovascular or endocrine disease. Rebound miosis has been reported one day after instillation.
Ocular adverse reactions include eye pain and stinging on instillation, temporary blurred vision and photophobia. Cardiovascular adverse reactions include increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage.
About Paragon BioTeck, Inc.
Paragon BioTeck is a privately held ophthalmic-focused biopharmaceutical and medical device company pursuing the development and commercialization of products addressing unmet medical needs in the fight to protect and preserve eyesight. For more information on the company and its work, visit http://www.paragonbioteck.com.