Home » Drug Information » FDA Approved Drugs » 2000
Medical Areas: Ophthalmology | Family Medicine
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Rescula (unoprostone isopropyl ophthalmic solution) 0.15%
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Ciba Vision
Approval Status: Approved August 2000
Treatment Area: For the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Rescula is a docosanoid compound recently approved by the FDA
for treatment of open-angle glaucoma or ocular hypertension. It is
used for the lowering of intraocular pressure in patients who
cannot tolerate or fail to respond to other such medications.
Research indicates that Rescula lowers intraocular pressure without
affecting cardiovascular or pulmonary function. The recommended
dosage is one drop in the affected eye(s) twice daily, and it may
be used concomitantly with other topical ophthalmic drug
Glaucoma refers to a group of eye diseases that have certain
common features, which can include an abnormally high eye pressure,
damage to the optic nerve, and visual field loss. It is estimated
that 67 million people worldwide will have glaucoma by the year
2000. (from the Glaucoma Research Foundation).
Clinical studies showed that in subjects with a mean baseline
intraocular pressure (IOP) of 23 mm Hg, Rescula lowers intraocular
pressure by approximately 3 to 4 mm HG throughout the day. Rescula
appears to lower intraocular pressure without affecting
cardiovascular or pulmonary function. No loss of efficacy was
observed over 12 months. 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.
Ocular side effects reported with the use of Rescula include
(but are not limited to) the following:
- Burning or stinging (10 - 25% of patients)
- Dry eyes (10 - 25% of patients)
- Itching (10 - 25% of patients)
- Increased length of eyelashes and redness (10 - 25% of
- Abnormal vision (5 - 10% of patients)
- Eyelid disorder (5 - 10% of patients)
The most frequently reported non-ocular adverse event associated
with the use of Rescula in clinical trials was flu syndrome, which
was observed in approximately 6% of patients.
Rescula may also gradually change eye color, increasing the
amount of brown pigment in the iris. The long-terms effects and
consequences of potential injury to the eye are unknown. The change
in iris color occurs slowly and may not be noticeable for months to
Mechanism of Action
When instilled in the eye, Rescula is believed to reduce
elevated intraocular pressure (IOP), by increasing the outflow of
aqueous humor, but the exact mechanism is unknown at this time.
Rescula contains benzalkonium chloride which may be adsorbed by
contact lenses. Contact lenses should be removed prior to
administering the solution. Lenses may be reinserted fifteen
minutes after Rescula has been applied. Additionally, if more than
one topical ophthalmic drug is being used, the drugs should be
administered at least five minutes apart.
For additional information on glaucoma, please visit the web
site of the Glaucoma Research Foundation.