The US Food and Drug Administration (US FDA) has approved Paragon BioTeck's phenylephrine hydrochloride ophthalmic solution, USP 2.5 per cent and 10 per cent, to dilate the pupil, is readily available through Bausch Lomb or primary wholesaler.
"Paragon is committed to working proactively with the 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 & chief executive officer, of Paragon BioTeck, Inc. "We are acutely aware of just how important phenylephrine's unique mechanism of action is in providing maximum pupil dilation, which is of paramount importance in protecting the public health through early detection, diagnosis and treatment of serious eye diseases."
There is no longer a need to continue using unapproved versions of phenylephrine hydrochloride ophthalmic solution, as Paragon BioTeck's FDA approved phenylephrine hydrochloride ophthalmic solution, USP 2.5 per cent and 10 per cent is readily available through Bausch Lomb or primary wholesaler.
Phenylephrine hydrochloride ophthalmic solution, USP 2.5 per cent and 10 per cent 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.
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.