ACL » Topics » New RETAANE ® Clinical Study Data Reported at Macula Society Meeting
This excerpt taken from the ACL 6-K filed Feb 25, 2005.
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.
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.
Alcons new counter pressure device, reflux was effectively controlled during
administration of RETAANE® in Dr. Hudsons and Dr.
Roys 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
Robertson, PhD, vice president of ophthalmic research and development at Alcon, added,
This study responds to the FDAs 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
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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