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Cyclosporin compositions for ocular rosacea treatment

Cyclosporin compositions for ocular rosacea treatment description/claims

This application is a continuation of U.S. patent application Ser. No. 11/781,095, filed Jul. 20, 2007, which application is based, and claims priority under 35 U.S.C. § 120 to U.S. Provisional Application Ser. No. 60/820,239, filed Jul. 25, 2006; U.S. Provisional Application Ser. No. 60/829,796, filed Oct. 17, 2006; U.S. Provisional Application Ser. No. 60/829,808, filed Oct. 17, 2006; U.S. Provisional Application Ser. No. 60/883,525, filed Jan. 5, 2007; U.S. Provisional Application Ser. No. 60/916,352, filed May 7, 2007; and U.S. Provisional Application Ser. No. 60/869,459, filed Dec. 11, 2006; each of which is hereby incorporated by reference in their entirety.

Rosacea is a chronic and common skin disorder with no identified cause or cure. The pathogenesis of rosacea is thought to have multiple factors. Possible factors include exposure to the demodex folliculorum mite, gastrointestinal disease or a vasodilation disorder, and other triggers such as diet or sunlight. Patients may present with a variety of symptoms, including inflammatory papules, edema, telangiectasia, rhinophyma and ocular symptoms.

The ocular signs of rosacea include blepharitis, including anterior blepharitis, conjunctivitis, iritis, iridocyclitis, keratitis, meibomian gland dysfunction, telangiectasia, erythema, chalazion, hordeolum, interpalpebral hyperemia, conjuctival hyperemia, ciliary base injection, bulbar injection, crusts, sleeves, and superficial punctuate keratopathy. The ocular symptoms are nonspecific and may include burning, tearing, decreased tear secretion, redness, and foreign body or gritty or dry sensation, irritation, Itchiness, Blurred vision, Photosensitivity, Watery eyes, bloodshot eyes, Burning, telangiectasia, irregularity of the lid margins, and meibomian gland dysfunction.

FIG. 1 Mean (±SD) cornea cyclosporine A concentrations (semi-log) following a single bilateral topical ocular instillation of one of three 0.05% cyclosporine A formulations to New Zealand White rabbits.

FIG. 2 Mean (±SD) conjunctiva cyclosporine A concentrations (semi-log) following a single bilateral topical ocular instillation of one of three 0.05% cyclosporine A formulations to New Zealand White rabbits.

FIG. 3 Mean (±SD) sclera cyclosporine A concentrations (semi-log) following a single bilateral topical ocular instillation of one of three 0.05% cyclosporine A formulations to New Zealand White rabbits.

FIG. 4 Mean (±SD) eyelid margin cyclosporine A (concentrations (semi-log) following a single bilateral topical ocular instillation of one of three 0.05% cyclosporine A formulations to New Zealand White rabbits.

FIG. 5 Mean (±SD) nasolacrimal duct cyclosporine A concentrations (semi-log) following a single bilateral topical ocular instillation of one of three 0.05% cyclosporine A formulations to New Zealand White rabbits.

We have surprisingly discovered that aqueous compositions of cyclosporin A at a concentration of less than about 0.05% (w/v) can be prepared that will be effective in the treatment of ocular rosacea.

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Cyclosporin compositions
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