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 There is no cure for glaucoma, which damages the optic nerve and is
expected to affect more than 4 million Americans by 2030, up from
2.7 million today. But treatments help patients manage the disease
and may prevent the onset of blindness.
The new treatments promise to improve outcomes and reduce
side-effects associated with current medicines, exploiting a long
dearth of innovative new products for the disease. No new class of
medicine has been introduced since Pfizer Inc’s Xalatan, known
generically as latanoprost, in 1996.
The newcomers aim to disrupt market-leaders Alcon, a division of
Novartis AG, Allergan Inc, Pfizer and Valeant Pharmaceuticals
International Inc.
Leading the pack is Aerie Pharmaceuticals Inc, which plans to launch
its novel eye-drop Rhopressa in 2017 and another treatment, Roclatan,
a year later. The company sold 6.7 million shares for $10 each in
its 2013 market debut. They now top $26.
Following Aerie is Inotek Pharmaceuticals, whose trabodenoson
eye-drop is entering late-stage trials expected to be completed by
2017. Inotek has announced plans to sell 4.6 million shares at
between $13 and $15 each in an IPO expected soon.
Drugs to combat glaucoma, the second-leading cause of blindness in
the world, work by reducing pressure inside the eye. Aerie and
Inotek's drugs are the first to target the trabecular network, the
main drain through which fluid flows out of the eye, though they do
so in different ways.
Taking a different approach is Ocular Therapeutix Inc, which is
developing a tiny device that can be inserted into the eye to
deliver regular medication. The product is in mid-stage clinical
trials. Ocular's shares have risen to more than $30 from their IPO
price of $13 last year.
"There's a new graduating class of next-generation treatments," said
William Slattery, partner at Deerfield Management Company L.P.,
which holds shares in Aerie and recently provided the company with
$125 million in financing.
Prostaglandins are the most widely-prescribed glaucoma drugs. They
include latanoprost, Alcon’s Travatan, and Allergan’s Lumigan. But
prostaglandins can cause eye redness and changes to eye pigmentation
and eyelash length. Most patients need extra therapies such as
timolol, a decades-old beta-blocker that lowers eye pressure but can
slow a patient’s heart beat.
Rhopressa and trabodenoson work differently. They do not cause
changes to eye pigmentation or lash length, though Rhopressa can
still cause red eye. Experts say even incremental improvements in
treatments would be welcome.
"We continue to have people who are going blind from glaucoma and
that's a problem," said Dr. Wiley Chambers, deputy director of the
U.S. Food and Drug Administration’s transplant and ophthalmology
products. "We need alternatives."
WAVE OF INNOVATION
So far, analysts are betting that Aerie's second drug, Roclatan,
will be the most effective at lowering eye pressure. It is a
fixed-dose combination product that includes Rhopressa and
latanoprost. Both those constituents cause red eye, however.
Inotek's trabodenoson does not appear to cause red eye, making it a
potentially attractive product for physicians to prescribe as an
add-on therapy. The company is also testing it in a fixed dose
combination with latanoprost.
Vicente Anido Jr., Aerie's chief executive, predicts that Rhopressa
and Roclatan could generate $1 billion apiece worldwide a year. "We
think we could end up being the next Allergan or Alcon," he said.
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Some analysts agree with Anido's projections, and say that Aerie
could become a takeover target if late-stage clinical trial data to
be released mid-year are positive.
But Catherine Daly, a neurology and ophthalmology analyst at
research and consulting firm GlobalData Healthcare, thinks Aerie's
projections are too high. She sees combined sales closer to $600
million.
"It's going to take a lot to move people away from using
prostaglandins, which have a long track record," she said.
Daly predicts sales of trabodenoson will be less than half those of
Rhopressa and Roclatan, in part because Aerie is projected to reach
the market first. In addition, Aerie's drugs may work in a broader
patient population, including those whose eye pressure is normal but
are still losing vision.
Inotek, which last year hired long-time biotech executive
David Southwell as its chief executive, has received less attention
than Aerie. That could change after the company goes public.
Southwell is a former investment banker and canny dealmaker. As
chief financial officer at Human Genome Sciences he oversaw that
company's $3 billion sale to GlaxoSmithKline Plc in 2012.
The wave of innovation comes as big drugmakers are getting out of
eye-care or consolidating.
The most innovative of the big company products appears to be Bausch
& Lomb's Vesneo, which represents an advance on existing therapies
and could be on the market by next year. It combines latanoprost
with nitric oxide to add an extra pressure-lowering boost. The
company has said the drug could generate $500 million in u.s. sales
and $1 billion globally.
Alcon, whose glaucoma treatment revenues stood at $1.3 billion last
year, said it was "evaluating external partnerships" for access to
new glaucoma technologies.
Firms are also working on new drug delivery mechanisms. Allergan's
bimatoprost SR is in late-stage clinical trials and could become the
first long-acting implant to reach the market. Still, it faces
competition from several small firms including Ocular Therapeutix,
pSivida and Mati Therapeutics.
“By using their own proprietary delivery platforms with other
prostaglandin drugs they could become major competitors to Allergan
in the future,” Daly said.
(Editing by Stuart Grudgings)
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