Compositions and methods for treating noninfectious uveitis

Patent metadata

Field	Value
Publication number	US-2022249517-A1
Application number	US-202117478112-A
Country	US
Kind code	A1
Filing date	Sep 17, 2021
Priority date	Mar 5, 2018
Publication date	Aug 11, 2022
Grant date	—

Abstract

The present invention relates to methods, devices, and compositions for treating ocular disorders such as uveitis, macular edema associated with uveitis, and diabetic macular edema. For example, the methods include treatment of subjects having macular edema associated with non-infectious uveitis, or diabetic macular edema, by administering to the subjects a triamcinolone composition via non-surgical administration to the suprachoroidal space (SCS) of the eye.

First claim

1 - 54 . (canceled)

55 . A method of treating macular edema associated with uveitis in a human subject in need thereof, comprising administering to the human subject a composition comprising an effective amount of triamcinolone acetonide to the suprachoroidal space (SCS) of the eye, wherein the method increases a Best Corrected Visual Acuity (BCVA) of at least 15 letters from a baseline measurement prior to the administration of the triamcinolone acetonide to the SCS at 24 weeks.

56 . The method of claim 55 , wherein the effective amount of triamcinolone acetonide is about 4 mg.

57 . The method of claim 55 , wherein the triamcinolone acetonide is formulated at 40 mg/mL.

58 . The method of claim 57 , wherein the composition comprises 0.02% (w/v) polysorbate 80 and 0.5% (w/v) carboxymethylcellulose sodium.

59 . The method of claim 58 , wherein the triamcinolone acetonide is formulated as a suspension of microparticles having a D 50 of 3 μm or less.

60 . The method of claim 55 , wherein the uveitis is a non-infectious uveitis selected from the group consisting of pan, anterior, intermediate, or posterior uveitis.

61 . The method of claim 58 , wherein the uveitis is a non-infectious uveitis selected from the group consisting of pan, anterior, intermediate, or posterior uveitis.

62 . The method of claim 61 , wherein the increase in BCVA from baseline is maintained for 48 weeks.

63 . The method of claim 61 , wherein administering results in no change in intraocular pressure.

64 . The method of claim 61 , wherein the administering results in decreased ocular inflammation.

65 . The method of claim 61 , wherein the administering comprises the use of a microneedle.

66 . The method of claim 65 , wherein the microneedle is an SCS microinjector.

67 . The method of claim 65 , wherein the microneedle comprises a 30-gauge needle that is about 900 μm or about 1100 μm in length.

68 . The method of claim 65 , wherein the administering comprises the steps of: (a) positioning the needle perpendicular to the ocular surface of the eye, between 4-4.5 mm posterior to the limbus of the eye; (b) compressing the conjunctiva and sclera to create a dimple, and (c) injecting the composition over several seconds.

69 . The method of claim 67 , wherein the administering comprises the steps of: (a) positioning the needle perpendicular to the ocular surface of the eye, between 4-4.5 mm posterior to the limbus of the eye; (b) compressing the conjunctiva and sclera to create a dimple, and (c) injecting the composition over several seconds.

70 . The method of claim 58 , comprising administering two doses of the composition about 12 weeks apart.

71 . A method of treating macular edema associated with uveitis in a human subject in need thereof, comprising administering to the human subject a composition comprising an effective amount of triamcinolone acetonide to the suprachoroidal space (SCS) of the eye, wherein the method reduces a central subfield thickness (CST) of the human subject at 24 weeks from a baseline measurement prior to the administration of the triamcinolone acetonide to the SCS, wherein the reduction in CST is by at least about 100 μm from the baseline.

72 . The method of claim 71 , wherein the effective amount of triamcinolone acetonide is about 4 mg.

73 . The method of claim 71 , wherein the triamcinolone acetonide is formulated at 40 mg/mL.

74 . The method of claim 73 , wherein the composition comprises 0.02% (w/v) polysorbate 80 and 0.5% (w/v) carboxymethylcellulose sodium.

75 . The method of claim 74 , wherein the triamcinolone acetonide is formulated as a suspension of microparticles having a D 50 of 3 μm or less.

76 . The method of claim 71 , wherein the uveitis is a non-infectious uveitis selected from the group consisting of pan, anterior, intermediate, or posterior uveitis.

77 . The method of claim 74 , wherein the uveitis is a non-infectious uveitis selected from the group consisting of pan, anterior, intermediate, or posterior uveitis.

78 . The method of claim 77 , wherein the reduction in CST from baseline is maintained for 48 weeks.

79 . The method of claim 77 , wherein administering results in no change in intraocular pressure.

80 . The method of claim 77 , wherein the administering results in decreased ocular inflammation.

81 . The method of claim 77 , wherein the administering comprises the use of a microneedle.

82 . The method of claim 81 , wherein the microneedle is an SCS microinjector.

83 . The method of claim 81 , wherein the microneedle comprises a 30-gauge needle that is about 900 μm or about 1100 μm in length.

84 . The method of claim 81 , wherein the administering comprises the steps of: (a) positioning the needle perpendicular to the ocular surface of the eye, between 4-4.5 mm posterior to the limbus of the eye; (b) compressing the conjunctiva and sclera to create a dimple, and (c) injecting the composition over several seconds.

85 . The method of claim 83 , wherein the administering comprises the steps of: (a) positioning the needle perpendicular to the ocular surface of the eye, between 4-4.5 mm posterior to the limbus of the eye; (b) compressing the conjunctiva and sclera to create a dimple, and (c) injecting the composition over several seconds.

86 . The method of claim 74 , comprising administering two doses of the composition about 12 weeks apart.

Assignees

• Clearside Biomedical Inc

Inventors

• White Daniel
• Noronha Glenn
• Kissner Jennifer

Classifications

• A61P27/02

  Ophthalmic agents · CPC title

• A61M2037/0061

  Methods for using microneedles · CPC title

• A61K47/26

  Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin · CPC title

• A61K47/12

  Carboxylic acids; Salts or anhydrides thereof · CPC title

• A61K47/38

  Cellulose; Derivatives thereof · CPC title