Methods and compositions for preventing or treating ophthalmic conditions
Inventors
Liu, Liping • Tang, Shibo • Liang, Xiaoling
Assignees
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Publication Number
US-11612633-B2
Publication Date
2023-03-28
Expiration Date
Abstract
The disclosure generally describes methods of preventing or treating ophthalmic diseases or conditions in a mammalian subject, such as diabetic retinopathy, cataracts, retinitis pigmentosa, glaucoma, macular degeneration, choroidal neovascularization, retinal degeneration, and oxygen-induced retinopathy. The methods comprise administering an effective amount of an aromatic-cationic peptide to subjects in need thereof.
Core Innovation
The disclosed invention relates to aromatic-cationic peptides for treating or preventing an ophthalmic condition in a mammalian subject in need thereof. The method comprises administering a therapeutically effective amount of a peptide represented by the formula D-Arg-2′,6′-Dmt-Lys-Phe-NH2 or Phe-D-Arg-Phe-Lys-NH2. The peptide variants are described as SS-31/MTP-131/Bendavia or SS-20.
The ophthalmic conditions explicitly discussed include retinitis pigmentosa, as well as diabetic retinopathy, cataracts, glaucoma, macular degeneration, choroidal neovascularization (CNV), retinal degeneration, and oxygen-induced retinopathy. The peptide is administered as part of a pharmaceutical composition using ophthalmic formulations, with administration routes including intraocular and iontophoretic administration, and combination-therapy formulation options with a second active agent administered separately, sequentially, or simultaneously.
The document provides peptide structure and compositional parameter constraints for the aromatic-cationic peptide, including relationships related to net positive charge and aromatic groups, an amino acid count, optional non-natural and/or D-amino acids, and an amidated C-terminus. It also states that the peptides are provided in therapeutically effective amounts for the treatment or prevention of the ophthalmic conditions, and that the peptides can reduce apoptosis and reactive oxygen species, preserve mitochondrial membrane potential, and mitigate retinal and microvascular pathology across multiple model contexts described in the document.
Claims Coverage
The independent claim provides a method for treating or preventing an ophthalmic condition in a mammalian subject by administering one of two specific aromatic-cationic peptide formulas, with the ophthalmic condition specified as retinitis pigmentosa. Across the dependent claims, the peptide variant, subject class, administration routes, and combination therapy with a second active agent are further specified, including restriction to categories and a defined enumerated list of named agents.
Treating or preventing retinitis pigmentosa with a therapeutically effective amount of a specified peptide formula
A method for treating or preventing an ophthalmic condition in a mammalian subject in need thereof, comprising administering a therapeutically effective amount of a peptide represented by D-Arg-2′,6′-Dmt-Lys-Phe-NH2 or Phe-D-Arg-Phe-Lys-NH2, wherein the ophthalmic condition is retinitis pigmentosa.
Using the D-Arg-2′,6′-Dmt-Lys-Phe-NH2 peptide variant
The method uses the specific peptide D-Arg-2′,6′-Dmt-Lys-Phe-NH2.
Administering the peptide by one of multiple delivery routes
The method includes administering the peptide by one of several delivery routes, including intraocular, iontophoretic, oral, topical, systemic, intravenous, subcutaneous, or intramuscular administration.
Combination therapy by administering a second active agent separately, sequentially, or simultaneously
The method further includes administering a second active agent either separately, sequentially, or simultaneously.
Selecting the second active agent from specified therapeutic categories
The second active agent is chosen from antioxidant, metal complexer, anti-inflammatory drug, antibiotic, or antihistamine.
Selecting the second active agent from a defined enumerated list of named active agents
The second active agent is selected from a defined list of named active agents, including pharmaceutically acceptable salts and combinations thereof.
Claim coverage centers on administering a therapeutically effective amount of either D-Arg-2′,6′-Dmt-Lys-Phe-NH2 or Phe-D-Arg-Phe-Lys-NH2 to treat or prevent retinitis pigmentosa in a mammalian subject. Dependent coverage specifies the SS-31 variant, provides multiple administration routes, and adds combination therapy with a second active agent, first restricted to therapeutic categories and then further restricted to an enumerated list of named agents.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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