Novartis says glaucoma
stent setback will not derail Alcon spin-off
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[August 29, 2018]
By John Miller
ZURICH (Reuters) - Novartis' eye care unit
Alcon is withdrawing a surgical stent for glaucoma patients after
clinical data showed it may damage the eye, but the Swiss drugmaker said
the move would not affect plans to spin off the unit next year.
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Novartis shares fell 0.6 percent by 0832 GMT on Wednesday, although
one analyst said the company's swift reaction should help keep it
out of the crosshairs of lawyers.
As part of its voluntary withdrawal of the CyPass Micro-Stent, Alcon
advised surgeons treating glaucoma patients to stop implanting the
stents immediately, the company said in a statement on Wednesday.
"We believe that withdrawing the CyPass Micro-Stent from the market
is in patients' best interest and is the right thing to do," said
Alcon's chief medical officer, Stephen Lane.
"Although we are removing the product from the market now out of an
abundance of caution, we intend to partner with the FDA and other
regulators to explore labeling changes that would support the
reintroduction of the CyPass Micro-Stent in the future."
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The stent was designed to reduce pressure in the eye.
Based on two years of clinical data, the U.S. Food and Drug
Administration had approved the CyPass Micro-Stent in July 2016 for
use in conjunction with cataract surgery in adult patients with
mild-to-moderate primary open-angle glaucoma.
But five-year post-surgery data showed patients experienced
statistically significant endothelial cell loss compared to the
group who underwent cataract surgery alone. Endothelial cells are
believed to help maintain visual function.
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The Alcon eye care business has highlighted the stent's contribution
to a recovery in sales. In the second quarter, Novartis said
double-digit percentage growth of implantables including the CyPass
stent helped drive an 8 percent surge in revenue from its surgical
devices to $1.03 billion.
But a company spokesman said that CyPass sales were "immaterial" to
Alcon's total sales of $3.6 billion in the first half, and there
would be no change to its target of mid-single-digit percentage
sales growth in constant currencies this year.
The spokesman said the withdrawal would not have an impact on
Alcon's plans for a spin-off in the first half of 2019.
Zuercher Kantonalbank analyst Michael Nawrath estimated revenue from
the stent at around $90-100 million.
Novartis's quick move to withdraw the device after five years of
patient follow-up will give little leverage to any lawyers
considering potential claims against Alcon, he said.
"A withdrawal is always negative, but if you react appropriately you
can avoid becoming the potential target of litigation and legal
costs," Nawrath said.
(Reporting by John Miller, Editing by Michael Shields and Louise
Heavens)
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