ALCON's CILOXAN OPHTHALMIC CIPROFLOXACIN SOLUTION

Executive Summary

ALCON's CILOXAN OPHTHALMIC CIPROFLOXACIN SOLUTION is first quinolone antimicrobial to be approved for ocular use. The ciprofloxacin HCI 0.3% ophthalmic solution was approved on Dec. 31 for treating bacterial conjunctivitis and corneal ulcers. The NDA for Ciloxan was submitted by Alcon in July 1989. Approval took about 17 months. Miles, the innovator of the broad spectrum quinolone ciprofloxacin, markets the drug as Cipro tablets and Cipro I.V. Alcon began shipping Ciloxan on Jan. 24 and will start detailing the product to physicians by the end of February or the beginning of March. Ciloxan is available in 2.5 ml and 5 ml plastic dispensers at a price to wholesalers of $ 6.90 and $ 12.60, respectively. In a Feb. 8 release, Alcon noted that the use of Ciloxan in patients with corneal ulcers "may reduce or eliminate the need for costly hospitalization." Current corneal ulcer therapy, Alcon said, "often requires physicians or pharmacists to extemporaneously modify commercially available antimicrobials to prepare a fortified product." Merck has an NDA pending for use of a fluoroquinolone in ocular infections: Chibroxin (nonfloxacin) 0.3% ophthalmic solution. Merck markets norfloxacin tablets (Noroxin) for the treatment of urinary tract infections. Allergan reported in December that its ophthalmic ofloxacin NDA is "in the final stages of review" ("The Pink Sheet" Dec. 10, In Brief).