By Cassandra Jaramillo
Aerie Pharmaceuticals Inc. said Monday that the U.S. Food and
Drug Administration has allowed the drug maker to modify what will
determine a successful late-stage clinical trial for its glaucoma
treatment.
Shares of Aerie Pharmaceuticals, down 54% over the past three
months, jumped 43% to $18.93 in after-hours trading as the trial's
new endpoints were seen as being easier to achieve.
Adding to the stock gains was the need for some investors to
cover their short positions. About 20% of the stock's float was
sold short, meaning those shares profit when the stock price
falls.
Aerie's glaucoma treatment, called Rhopressa, is a once-a-day
eye drop that targets the diseased tissue responsible for the
elevated intraocular pressures that result in glaucoma.
Under the pact with the FDA, Aerie is changing its primary
endpoint to include patients with baseline intraocular pressures
ranging from above 20 millimeters of mercury to below 25
millimeters of mercury.
The new range is the same as an earlier trial of Rhopressa, in
which the drug showed it was at least equally effective as a
current glaucoma treatment.
Aerie said the new endpoint range wouldn't require additional
patients for the current trial.
Previously, the trial's range included patients with baseline
intraocular pressures ranging from above 20 millimeters of mercury
to below 27 millimeters of mercury. Aerie said the previous range
will now represent a secondary endpoint range for the trial.
The company said three-month efficacy results from the current
trial are expected by the third quarter.
Additionally, Aerie said it expected to start another late-stage
trial for Rhopressa in the third quarter.
Write to Cassandra Jaramillo at Cassandra.Jaramillo@wsj.com
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