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:

Approval Status:

Approved August 2000

Specific Treatments:

For the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Therapeutic Areas

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General Information

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 products.

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 Results

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.

Side Effects

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 patients)
  • 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 several years.

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.

Additional Information

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.