Compositions and methods of use for treating aberrant inflammation in peri-ocular secretory glands or at the ocular surface

Abstract

Provided herein are pharmaceutical compositions comprising a therapeutically effective amount of a lipophilic compound and a pharmaceutically acceptable carrier adapted for peri-ocular transdermal delivery of the lipophilic compound to one or more periorbital glands and / or the ocular surface tissues of a subject. Further provided herein are methods of using such pharmaceutical compositions for providing relief of one or more signs or symptoms of an ocular disease, methods of using one or more Meibomian glands (and meibum therein) as a drug delivery system for a lipophilic compound (e.g., a steroid) to the ocular surface, and kits related thereto.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS [0002] This application claims priority to U.S. Provisional Application 62 / 589,493, filed November 21, 2017, entitled "Compositions and Methods for the Treatment of Abnormal Inflammation in the Periocular Secretory Glands or on the Ocular Surface," the entire contents of which are via Incorporated herein by reference. [0003] Field of Invention [0004] The present invention relates to pharmaceutical compositions suitable for periocular transdermal delivery of one or more lipophilic compounds; methods of their use; and kits comprising such pharmaceutical compositions. Background technique [0005] Topical drops have become the delivery method of choice for eye care practitioners, especially for conditions such as dry eye, uveitis, bacterial conjunctivitis, and glaucoma, as the ocular surface is considered the primary target tissue for drug delivery. When the drops hit the eye, the three parts of the anterior segment (ie, the ...

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Problems solved by technology

[0006] However, topical eye drops have several disadvantages: 1) they are difficult for the patient to physically administer; 2) there are some physical and physiological barriers that protect the eye and significantly reduce the amount of drug delivered (e.g., low corneal permeability, blinking reflex and tear turnover); 3) epithelial tight junctions prevent diffusion of larger molecules

However, only short-term use of topical ophthalmic corticosteroids given as eye drops is generally recommended because long-term use may lead to adverse ocular events, including increased intraocular pressure (IOP), cataracts, and ocular infections (Becker, 1964 ; Bowling and Russell, 2011; Dinning, 1976)

[0010] Although steroid ointments / creams are widely used to manage chronic or chronic non-ophthalmologic inflammatory conditions (due to their low penetration / permeability), current formulations of steroid ointments / creams are strongly not recommended for long-term use on or near the eye used because ophthalmic use of these preparations may cause serious adverse events such as increased IOP (which may lead to ocular hypertension or glaucoma, or to decreased vision), posterior capsular cataract, delayed corneal epithelial healing, corticosteroids Meningitis, mydriasis and ptosis, infection, and other possible side effects (e.g., transient eye discomfort, steroid-induced calcium deposits, etc.)

In fact, topical application of typical dexamethasone ointment to eyelids in children significantly increased IOP

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