seeks to prove intracameral efficacy and safety at around 100 participat-
ing sites and, if so, secure FDA approval. Currently it's in the planning
phase and seeking funding from a combination of federal and pharma-
ceutical industry sources, says Douglas Rhee, MD, chair of the
Department of Ophthalmology & Visual Sciences at Case Western
Reserve University in Cleveland, Ohio. Dr. Rhee, who is leading the
study, isn't one of the growing number of U.S. surgeons — roughly 45%,
per an ASCRS survey — who performs intracameral injections.
"I have been happy with my regimen of post-operative topical," he
says. "Actually, I think it makes me a perfect person to study this,
because there's the important concept of equipoise, which means you
have to truly believe that either option could be good and that either
option could win out."
2. There's still no single-use product. Just why is the FDA so
reluctant to approve a treatment that's accepted practice elsewhere?
For starters, Dr. Miller says the FDA's stringent protocol requirements
for clinical trials and studies are difficult to achieve in this case
because endophthalmitis is so rare. Secondly, adds Dr. Miller, what
incentive is there for a pharmaceutical company to get a product on
the market that might sell for $25 a vial — and cannibalize sales of
already successful antibiotic prophylactics?
3. Intracameral antibiotics must be compounded. You must
rely on a compounding pharmacy to prepare intracameral injections.
"You have to trust the pharmacy to mix it properly and not contami-
nate it," says Dr. Miller. "That's what scares a lot of people from using
intracamerals: the incompetence of the source."
Among the potential problems from poor compounding are the inad-
vertent presence of preservatives, overdosing that can lead to compli-
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