Paragon BioTeck, Inc., a privately held biopharmaceutical company, has received US FDA approval of Phenylephrine hydrochloride ophthalmic solution, USP 2.5% and 10%, to dilate the pupil on March 20, 20130.  Phenylephrine hydrochloride ophthalmic solution, USP 2.5% and 10% is readily available through Bausch + Lomb.

“Paragon is committed to working proactively with the US FDA in an effort to prevent disrupting supply of this and future drugs that play a vital role in managing ocular health,” said Patrick H. Witham, president & CEO of Paragon BioTeck, Inc.

Phenylephrine hydrochloride ophthalmic solution, USP 2.5% and 10% is an alpha-1 adrenergic receptor agonist used for dilation of the pupil due to its vasoconstrictor and mydriatic action. Phenylephrine possesses predominantly a-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, USP 10% is contraindicated in patients with hypertension or thyrotoxicosis, as well as in paediatric patients under the age of one due to the increased risk of systemic toxicity. Phenylephrine hydrochloride ophthalmic solution, USP 2.5% should be used in these patients. It’s for topical ophthalmic use only, and not for injection.

Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing, and restoring people’s eyesight.

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.