BAUSCH & LOMB'S OPCON A TO BE AVAILABLE OVER-THE-COUNTER

BAUSCH & LOMB'S OPCON A TO BE AVAILABLE OVER-THE-COUNTER by the end of 1994 following FDA's approval of the company's Rx-to- OTC switch application on June 8. The antihistamine/decongestant eye drops (pheniramine .315%/naphazolinc HCl .027%) "will be available in food and drug stores and mass merchandise outlets across the country by late 1994," Bausch & Lomb said. The NDA (20- 065) switch application, which was filed in March 1990, included clinical trial data and manufacturing information, Bausch & Lomb said.

Opcon A has been available by prescription for 14 years and is indicated for temporary relief of redness and itching of the eye due to ragweed, pollen, and animal hair, The product will be sold in a .5 ounce bottle. The OTC recommended dosage is 1-2 drops four times daily. "Some users may experience a brief tingling sensation," approved draft labeling states.

Opcon A combines the vasoconstrictor ingredient naphazoline, which acts as an ophthalmic decongestant, with the antihistamine pheniramine. A number of OTC eye redness products currently contain naphazolinc, which is listed in the Ophthalmic Drug Products Final Monograph, including Ross Labs Clear Eyes.

In the approval letter, FDA warns that any advertising or promotional materials for Opcon A "will be considered false and misleading if it presents the product as safe and effective in the treatment of allergies, the treatment of ocular discomfort/irritation or as an ocular lubricant."