RESTASIS

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Definition and Pathology

Chronic Dry Eye is a condition involving abnormalities and deficiencies in the tear film initiated by a variety of causes.

Keratoconjunctivitis sicca (KCS) – also known as Chronic Dry Eye or Dry Eye Disease – is a condition caused by many factors that can result in inflammation of the eye and the tear-producing glands. One cause of Chronic Dry Eye is inflammation, which can decrease the eye’s natural ability to produce normal tears that protect the surface of the eye and keep it moist and lubricated.

Many aspects of tear production, tear composition, and the ocular surface appear to be interconnected by a neural feedback loop. Essentially, this neural loop controls tear production according to the composition of tears at the ocular surface. That is, tear composition is normally "sensed" by receptors on the ocular surface, and this information is transmitted via sensory (afferent) nerve fibers to the brain. In response, the brain then sends signals back via efferent nerve fibers to the tear-secreting glands. When stimulated by these secretomotor nerve impulses, the lacrimal glands secrete more tears.

Click on the step numbers in the illustration below to activate the feedback loop. To compare how Chronic Dry Eye affects the feedback loop, click on the "CHRONIC DRY EYE TEAR PRODUCTION" button in the top right of the illustration and repeat the step process.

Recent evidence suggests that there may be dysfunction of one or more aspects of this neural feedback loop in Chronic Dry Eye patients. For example, the increased osmolarity of tears in patients with dry eye can impact many aspects of the normal physiology of the ocular surface, affecting the ability of the sensory nerves to carry information to the brain. This results in a failure of the signaling system that would normally increase tear production.

Click on the "CHRONIC DRY EYE TEAR PRODUCTION" menu button in the illustration above and step through the process to compare to normal tear production.

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RESTASIS® Ophthalmic Emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Important Safety Information:

RESTASIS® is contraindicated in patients with active ocular infections and has not been studied in patients with a history of herpes keratitis.

The most common adverse event was ocular burning (upon instillation) – 17%. Other events reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).

Please see full prescribing information for RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%.