Ciba Vision, The Eye Care Unit Of
Novartis, Announced Today That The U.S. Food And Drug Administration
(FDA) Has Approved Rescula® (Unoprostone Isopropyl Ophthalmic Solution)
0.15%, A New Synthetic Docosanoid Compound For The Treatment Of
Open-Angle Glaucoma Or Ocular Hypertension.
Rescula differs from other anti-glaucoma drugs in that it is the only
available ocular therapy containing a docosanoid. Rescula consistently
and safely lowers intraocular pressure (IOP) when used as either a
monotherapy or in combination with other drugs, and IOP reduction is
maintained at a constant level throughout the day. In clinical studies
Rescula shows no loss of efficacy over 12 months.
"With this approval, we are now able to provide doctors with a major
new building block in glaucoma treatment," said Dan Myers, president of
CIBA Vision's North American Ophthalmics group. "Research shows that
unlike non- cardioselective beta blockers, Rescula safely lowers
intraocular pressure without affecting cardiovascular or pulmonary
The most common ocular adverse events with Rescula (occurring in
10-25% of patients during clinical studies) were burning/stinging,
burning and stinging upon instillation, dry eyes, itching, increased
length of eyelashes and injection(redness).
Patients will use Rescula, in the form of eye drops, twice a day. It
rapidly penetrates the cornea, achieving maximum effects in as soon as
"It's very exciting and important that we have as many different
as possible, including Rescula, in the medical treatment of glaucoma,"
Tom Mundorf, MD, a glaucoma specialist in Charlotte, N.C. "We're
learning in preliminary research that many of these medicines, in
addition to lowering pressure in the eye, may one day prove to have
other additional benefits to
the health of the eye."**
FDA approval of Rescula was based upon clinical studies in which more
than 1,100 patients were studied for up to 12 months at more than 50
study sites in the US, Canada, Europe and Israel.
Rescula at a 0.12% concentration is currently marketed in more than 25
countries globally. It has been licensed from Ueno Fine Chemicals
Industry, Ltd. and R-Tech Ueno, Ltd. of Japan, where more than 500,000
been treated over the last six years. Glaucoma is an eye disease
affecting an estimated 4 million people in the US and 5 million in
Europe, and is one of
the leading causes of preventable blindness.
Docosanoids are lipids with 22-carbon atoms. Naturally occurring
docosanoids are derived from docosahexaenoic acid. Numerous published
reports (in both human and animal studies) have shown that
docosahexaenoic acid is essential in the development and functioning of
Glaucoma is one of the leading causes of blindness in the US. As many
as 30 different types of the disease exist. Although the clinical
features of glaucoma are reasonably understood, the pathogenesis of
optic nerve damage remains unclear. Elevated IOP remains a
well-accepted and important risk factor in the development of the
disease; however, current understandings require definitions that are
multi-factorial or multi-dimensional.
In the early stages of the disease, glaucoma usually has no noticeable
symptoms. Loss of vision occurs in the late stages of the disease.
However, through early detection and continuing treatment, glaucoma
usually can be controlled and blindness prevented.
Patients with any type of glaucoma therapy sometimes get worse. As a
result, treatments may need to be changed. It is important for patients
to visit their eye care professionals regularly.
Rescula® is indicated for the lowering of intraocular pressure in
patients with open-angle glaucoma or ocular hypertension who are
intolerant of other intraocular pressure lowering medications or
insufficiently unresponsive (failed to achieve target IOP determined
after multiple measurements over
time) to another intraocular pressure lowering medication.