Allergan, Inc. has received approval from the United States Food & Drug Administration (FDA) for RESTASIS (cyclosporine ophthalmic emulsion, 0.05%).

FDA has approved Restasis for the following indication: to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (chronic dry eye). Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Published reports about cyclosporine suggest that it acts by reducing inflammatory cells like activated lymphocytes in the conjunctiva (Arch Ophthalmol 2000;118:1489-96) as well as by other means such as by increasing the number of mucin secreting goblet cells (Arch Ophthalmol 2002;120:330-7). Restasis action thus seems to be to reduce inflammation. However when patients are already taking other anti-inflammatory eyedrops then the beneficial effect of Restasis on tear production is not seen.

An important point to consider is that it may require several weeks of Restasis treatment (one drop twice a day) to produce a clinical therapeutic effect and it may take up to 6 months for maximum improvement. Therefore, Restasis is not an appropriate drug for immediate relief of an uncomfortable irritated eye. Among the available treatment options for immediate relief, topical corticosteroids (Lotemax, FML or Vexol) have the most rapid onset of action. They may be used for the short-term (2 to 4 weeks). It is worth remembering here that long-term use of streoid eyedrops can cause a rise in eye pressure (perhaps even glaucoma) and development of a cataract. Therefore, Restasis, which is devoid of these steroid-related side effects, seems to be a reasonable choice for long-term anti-inflammatory effect.

Allergan cites four clinical studies performed in approximately 1200 patients with moderate to severe dry eyes. 15% of Restasis-treated patients experienced an increase in Schirmer scores of 10 mm or greater compared with 5% of vehicle-treated patients (vehicle refers to the fluid in which Restasis is formulated and dispensed). However most patients will not get such a dramatic increase (clinical trial data). The Phase 3 clinical trials also reported that the corneal staining is reduced after using Restasis for 6 months. Reference:Ophthalmology 2000;107:631-9.
The vehicle also has some beneficial effect. This is perhaps not surprising because the vehicle contains ingredients like Castor Oil, which has also been shown to independently help in chronic dry eye (Ophthalmology 2002;109:2030-5). The most common side effect following the use of RESTASIS™ is ocular burning in 17% patients.

A recent article has reported that not only does topical cyclosporin eye drop therapy improved the signs and symptoms of dry eye disease, it also results in high patient satisfaction, fewer patients with chronic dry eye visiting the ophthalmologist, and less ancillary drug use (Manag Care Interface 2002;15:44-9). Since the eye drop is used twice a day, compliance is expected to be a non-issue. Restasis is prescription eyedrop (you cannot buy it over the counter without a doctors prescription) and is supplied as single use vials.

AgingEye Times comment: Restasis is not the cure for dry eyes. At best, it is a useful addition to the plethora of available options for managing dry eyes. As a first step one should use artificial tears, environmental measures to increase humidity, local treatment of blepharitis, meibomian gland disease (Rosacia related eyelid inflammation) & other external eye conditions and review oral medications that can cause dry eye. If despite these measures the eyes remain red and irritated, then Restasis treatment should be considered. The only justification in switching to Restasis if your current treatment regimen has adequately controlled your dry eye symptoms and the eyes feel comfortable is if you are on steroid eye drops. Otherwise, stay the current course and consider Restasis if symptoms of dry eyes worsen. It is reasonable to consider Restasis anti-inflammatory therapy for patients using artificial tears who continue to have clinically detectable ocular surface disease, particularly if inflammatory signs (for example, conjunctival redness) and irritation symptoms are present.
Some can have the erroneous impression that since Restasis is a prescription eye drop, it is likely to be more effective than over-the-counter eye drops for managing dry eyes. Being available only with a doctor's prescription is an FDA regulatory issue and has nothing to do with how effective a drug is.

For more information visit the Restasis website.

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