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New Dry Eye Treatment ALLERGAN'S RESTASIS APPROVED BY THE FDA
The First And Only Therapeutic Treatment To Increase Tear Production in Patients With Dry Eye Due To Ocular Inflammation RESTASIS is now available for the treatment of dry eyes.
RESTASIS (cyclosporine ophthalmic emulsion 0.05%)
Increased tear production was not seen
Restasis and Dry Eye Disease
Patients who do not produce enough tears often suffer from dry eye disease - one of the most common eye diseases in America.
Dry eye disease is a condition in which the tear film on the eye is diminished due to chronic inflammation. It is this inflammation that leads to decreased tear production, which is a common cause of dry eye disease.
Dry eye disease symptoms include a dry, gritty feeling in the eyes that is often accompanied by burning and redness. Often this condition can be very painful and interfere with sufferers' normal routines.
Restasis is the first product for dry eye disease that goes beyond providing temporary relief for dry eye symptoms to also treat inflammation, an underlying cause of the condition.
Restasis is also thought to act as a partial immunomodulator, although its exact mechanism of action is unknown.
Restasis is formulated as an eye drop and the recommended dosage is one drop in each eye twice a day approximately 12 hours apart. Restasis can be used concomitantly with artificial tears, allowing a 15 minute interval between products. Patients can expect their use of artificial tears to decrease while on Restasis.
Restasis should not be used while wearing contact lenses.
Unique Mechanism of Action That Increases Tear Production
Restasis was developed based on scientific research that shows inflammation is an underlying pathophysiology of dry eye disease. Current treatments, such as artificial tears and ointments, provide only symptomatic relief and do not address inflammation. Increased tear production was not seen in patients currently taking a topical anti-inflammatory or using punctal plugs.
Although the exact mechanism of action is not known, it is thought that Restasis works in two ways: 1.Partial immunomodulator (also known as the T-cell effect, meaning it inhibits T-cells from going into "battle mode" to protect the eyes from an outside attack);
2.Anti-inflammatory (prevents T cells from releasing cytokines, which are special proteins that start the inflammatory effect of dry eye disease). Restasis is the only dry eye disease therapy available that safely treats the underlying inflammation of the ocular (eye) surface and lacrimal (tear glands) tissue. This improves production to a normal volume of tears.
Clinical Development Program
The Restasis Phase III clinical development program consisted of four multi-center, randomized and controlled trials of 1200 patients diagnosed as suffering from moderate to severe keratoconjunctivitis sicca (dry eye disease).
These studies showed Restasis to be a safe and effective treatment for increasing Schirmer wetting in patients whose tear production was presumed to be suppressed due to ocular inflammation.
At six months, significantly more patients responded to Restasis than to treatment with a castor oil based topical emulsion vehicle.
Restasis should not be used in patients with active ocular infection and in patients with known or suspected sensitivity to any of the ingredients in the formulation.
The most common side effect among patients in the clinical trials was ocular burning, which occurred in approximately 17 percent of patients. - "Other side effects reported by one to five percent of patients include conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging and visual disturbance (most often blurring).
Restasis was found to be well-tolerated as well as safe and effective.
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