ACL » Topics » New RETAANE ® Clinical Study Data Reported at Macula Society Meeting

This excerpt taken from the ACL 6-K filed Feb 25, 2005.

New RETAANE® Clinical Study Data Reported
at Macula Society Meeting

FORT WORTH, Texas – February 25, 2005 – Alcon, Inc. (NYSE:ACL) reported the results of a clinical pharmacokinetic (PK) study evaluating the effectiveness of a counter pressure device (CPD) it developed to control reflux during the administration of RETAANE® 15mg (anecortave acetate for depot suspension) by posterior juxtascleral depot (PJD). The results of this PK study demonstrated that the CPD was effective in controlling drug reflux in 100 percent of the study participants. Reflux occurs when a portion of the drug leaks back out through the small incision in the conjunctiva during or immediately following the PJD procedure. Henry L. Hudson, M.D. of Tucson, Ariz., and Donald Roy, M.D. of Fresno, Calif., conducted the study. Allen C. Ho, M.D. of Philadelphia, Pa., presented the data at the 28th Annual Macula Society Meeting in Key Biscayne, Fla.

        In addition to measuring reflux, the study also measured the concentration of drug in blood plasma to confirm that effectively controlling reflux correlated with a higher level of drug absorption. The results of this study supported this relationship, as the patients in this study had higher concentrations of drug than did patients in previous trials who experienced drug reflux. These data establish that PJD administration of RETAANE® depot using the CPD results in effective delivery of the drug.

        “With Alcon’s new counter pressure device, reflux was effectively controlled during administration of RETAANE® in Dr. Hudson’s and Dr. Roy’s study,” said Dr. Ho. “These positive results clearly demonstrate that Alcon has successfully resolved drug reflux. Now physicians and patients can expect to have a sufficient amount of drug to last for the entire six-month treatment interval.”

        Stella Robertson, PhD, vice president of ophthalmic research and development at Alcon, added, “This study responds to the FDA’s specific request that we demonstrate that reflux can be controlled with the counter pressure device, and its success should mitigate any concern about reflux. We know from our phase III data that 57 percent of patients who experienced no reflux and were treated with RETAANE® within six months maintained their vision, compared to 49 percent of patients treated with VISUDYNE®*; and these results met the seven percent non-inferiority standard originally assigned to the trial. Furthermore, the overall results of our phase III trial meet a 14 percent criterion more specific to the patients evaluated in the study.”

        In addition the company announced the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for RETAANE® depot as fileable and has confirmed a priority review assignment. Based on the date of its submission, Alcon expects an FDA decision in late-May.

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