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Publication Number
US-11524045-B2
Publication Date
2022-12-13
Expiration Date
Abstract
Disclosed are ophthalmic compositions, methods for using the compositions and kits comprising the compositions for treating dry eye in a subject in need thereof. The composition comprises at least one peptide that is an inhibitor of trans-endothelial migration, an analogue, variant, derivative, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient for treating dry eye and ocular diseases of inflammation.
Core Innovation
Peptides are provided that inhibit trans-endothelial migration of T cells. The therapeutic objective is treatment of dry eye disease and ocular inflammatory diseases in which T-cell trans-endothelial migration is implicated. The approach is presented in terms of peptide and analogue variants defined by SEQ ID NO:1-35.
The disclosure frames the peptides as an ocular therapy with pharmaceutical composition embodiments. The scope includes ophthalmic compositions and administration in an ocular context, together with pharmaceutically acceptable excipient(s) and defined peptide variant sets. The peptide inhibitors are applicable across dry eye subtypes including keratoconjunctivitis sicca, aqueous tear-deficiency dry eye, and evaporative dry eye.
The disclosure includes reported supporting murine data comparing a peptide, SEQ ID NO:1, to Lifitegrast. The cited outcome measures include tear film break-up time, corneal fluorescein staining, and activated T-cell infiltration assessed by flow cytometry. The disclosure indicates use in broader ocular inflammatory diseases including uveitis, scleritis, post-eye surgery inflammation, conjunctivitis, glaucoma/ocular hypertension, and pterygium.
Claims Coverage
The partial record includes two independent claims. Across the independent claims, there are two main inventive features: a composition containing one or more peptides selected from a defined set of peptide sequences, and a peptide composition containing one or more peptides selected from the same defined set.
Composition comprising one or more peptides selected from SEQ ID NO:2-35
A composition comprising one or more peptides selected from the group consisting of the enumerated peptide sequences SEQ ID NO:2-35.
Peptide composition consisting of one or more peptides selected from SEQ ID NO:2-35
A composition consisting of one or more peptides selected from the group consisting of the enumerated peptide sequences SEQ ID NO:2-35.
The claim coverage is centered on compositions defined by a specific enumerated set of peptide sequences. One independent claim frames the invention as a composition comprising one or more of the selected peptides, while the other frames the invention as a composition consisting of one or more peptides comprising one selected peptide from the same set.
Stated Advantages
Inhibits trans-endothelial migration of T cells.
Supports improvement of tear film stability as measured by tear film break-up time.
Reduces corneal fluorescein staining.
Reduces activated T-cell infiltration as assessed by flow cytometry.
Documented Applications
Treating dry eye disease, including keratoconjunctivitis sicca, aqueous tear-deficiency dry eye, and evaporative dry eye.
Treating ocular inflammatory diseases, including uveitis, scleritis, post-eye surgery inflammation, conjunctivitis, glaucoma/ocular hypertension, and pterygium.
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