FDA warning on Avastin has few implications for ophthalmic use, investigator says

Discussion in 'Optometry Archives' started by Irv Arons, Oct 2, 2006.

  1. Irv Arons

    Irv Arons Guest

    There were recent news stories about a possible problem for cancer
    patients taking Avastin systemically. Dr. Phlip Rosenfeld, the first
    ophthalmologist to use this drug "off label" to treat age-related
    macular degeneration, addressed this question in today's issue of
    Ocular Surgery News Online edition:

    OSN SuperSite Top Story 9/29/2006

    FDA warning on Avastin has few implications for ophthalmic use,
    investigator says

    The Food and Drug Administration has added a new label warning to
    bevacizumab after reports of cases of reversible posterior
    leukoencephalopathy syndrome in cancer patients taking the drug

    But the warning should have little bearing on ophthalmologic uses,
    according to Philip J. Rosenfeld, MD, PhD, of the Bascom Palmer Eye
    Institute, one of the pioneer investigators of the off-label use of
    bevacizumab for treating exudative age-related macular degeneration.

    According to a letter issued by Genentech, the maker of Avastin
    (bevacizumab), the brain-capillary leak syndrome was reported in less
    than 0.1% of cancer patients using the drug for its approved

    Dr. Rosenfeld explained to Ocular Surgery News that ophthalmologic uses
    of Avastin involve markedly lower dosing regimens and local rather than
    systemic delivery of the drug as in oncologic uses. Cancer patients
    receive high intravenous doses of the drug every 2 weeks, while AMD
    patients receive small monthly doses via intravitreal injection. Thus,
    he said, the risk of reversible posterior leukoencephalopathy syndrome
    (RPLS) in AMD patients is "probably quite remote."

    Additionally, he noted, in oncologic uses, Avastin is used with
    adjuvant chemotherapy, which dramatically weakens patients' immune

    All patients who developed RPLS had weakened immune systems, Dr.
    Rosenfeld said.

    Other common side effects related to Avastin use in cancer patients,
    such as hypertension, have not been seen in AMD patients treated with
    the drug, which suggests that RLPS is not likely for ophthalmic
    patients, he added.

    "If you look at the many other drugs that we inject into the eye
    off-label, almost all of them have the possibility of serious systemic
    adverse events ... at their usual high dose systemically," Dr.
    Rosenfeld said. "[But] we don't see [these adverse events] when
    injected in small doses into the eye. So the issue with Avastin is not

    Irv Arons
    Irv Arons, Oct 2, 2006
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  2. Irv Arons

    LarryDoc Guest

    Irv, this is totally irrelevant to this newsgroup or the discussion
    relating to eyes in general, to wit:

    So why bother us with the rest of the "information" ?

    I just came back from a meeting on retina disease led by internationally
    renowned and published researchers. A key point, when discussing Avastin
    vs. Lucentis, for example, is that there is absolutely no clinical data
    that indicates that one drug is less systemically toxic than the other.
    None. Theory, yes. Fact, not supported.

    That's information.

    LB, O.D.
    LarryDoc, Oct 3, 2006
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  3. Irv Arons

    Irv Arons Guest


    That's exactly why I posted it -- because the original warning DOES NOT
    apply to ophthalmic uses of this drug -- and I wanted to make that

    As you know, Avastin does work very similarly to Lucentis (now FDA
    approved for AMD), but is much lower in cost. Anyone who is not covered
    by an insurance plan can get treated with Avastin (as an off label use)
    with out of pocket money.

    I just wanted to make clear that the dangers faced by systemic use of
    this drug to treat cancer patients do not apply to those who need this
    drug for ophthalmic use.

    Irv Arons
    Irv Arons, Oct 3, 2006
  4. Irv Arons

    Scott Guest

    When did you get to be the moderator of this group?
    I enjoy his posts.

    Scott, Oct 5, 2006
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