# US 2019/0169279 A1 · Compositions and methods of treating ocular diseases

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- Number: US 2019/0169279 A1
- Document ID: US20190169279A1
- Status: Published application
- Kind: A1
- Application number: 16/254,173
- Filed: 2019-01-22
- Published: 2019-06-06
- Earliest claimed: 2013-12-24
- Assignees: Novelmed Therapeutics, Inc.
- Applicants: Novelmed Therapeutics, Inc.
- Inventors: Rekha Bansal
- Web page: https://patentgrep.com/patent/US20190169279A1

## CPC

- C07K 16/18: against material from animals or humans
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 27/02: Ophthalmic agents
- C07K 16/22: against growth factors {; against growth regulators}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/55: Fab or Fab'
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/71: Decreased effector function due to an Fc-modification
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A method of treating a complement mediated ocular inflammation, hemorrhaging and fibrosis, and the pathological consequences thereof, in a subject in need thereof, the method comprising of administering to the subject a therapeutically effective amount of an antibody which inhibits the alternative complement pathway, wherein the antibody administered is effective for inhibiting complement mediated ocular inflammation, hemorrhaging and fibrosis, and the pathological consequences thereof.

## Claims

### Claim at position 1

1-79. (canceled)

### Claim 80

A method of treating ocular pathologies associated with fibrosis and hemorrhage within and around the macula of a subject in need thereof, the method comprising: administering to the subject a therapeutically effective amount of an anti-Bb antibody or antigen binding fragment thereof that binds to a component of alternative pathway and inhibits alternative pathway activation, wherein the ant-Bb antibody or antigen binding fragment thereof includes a light chain variable domain including 3CDRs of SEQ ID NO: 36 and a heavy chain variable domain including 3CDRs of SEQ ID NO: 79.

### Claim 81 (depends on 80)

The method of claim 80, wherein the antibody or antigen binding fragment thereof inhibits alternative complement pathway activation without inhibiting classical pathway activation.

### Claim 82 (depends on 80)

The method of claim 80, wherein the antibody or antigen binding fragment thereof selectively inhibits C3a, C5a, C3b, C5b, and C5b-9 produced by the alternative pathway, without inhibiting any of the classical pathway's ability to produce C3a, C5a, C3b, C5b, and C5b-9.

### Claim 83 (depends on 80)

The method of claim 80, wherein the antibody or antigen binding fragment thereof selectively inhibits formation of PC3bBb produced by the alternative pathway.

### Claim 84 (depends on 80)

The method of any of claim 80, wherein the antibody or antigen binding fragment thereof neutralizes the component of the alternative pathway function.

### Claim 85 (depends on 80)

The method of claim 80, wherein the therapeutically effective amount of antibody or antigen binding fragment thereof is an amount effective for comprehensive treatment of macular degeneration, geographic atrophy and retinal fibrosis.

### Claim 86 (depends on 80)

The method of claim 80, wherein the subject has dry age-related macular degeneration and the therapeutically effective amount of antibody or antigen binding fragment thereof is an amount of antibody effective to treat the dry age-related macular degeneration.

### Claim 87 (depends on 80)

The method of claim 80, wherein the subject has wet age-related macular degeneration and the therapeutically effective amount of antibody or antigen binding fragment thereof is an amount of anti-properdin antibody effective to treat the wet age-related macular degeneration.

### Claim 88 (depends on 80)

The method of claim 80, wherein the subject has geographic atrophy and the therapeutically effective amount of antibody or antigen binding fragment thereof is an amount of antibody or antigen binding fragment thereof effective to treat the geographic atrophy.

### Claim 89 (depends on 80)

The method of claim 80, wherein the subject has geographic atrophy post onset of wet age-related macular degeneration and the therapeutically effective amount of antibody or antigen binding fragment thereof is an amount of antibody or antigen binding fragment thereof effective to treat the geographic atrophy.

### Claim 90 (depends on 80)

The method of claim 80, wherein the subject has geographic atrophy post onset of dry age-related macular degeneration and the therapeutically effective amount of antibody or antigen binding fragment thereof is an amount of antibody or antigen binding fragment thereof effective to treat the geographic atrophy.

### Claim 91 (depends on 80)

The method of claim 80, wherein the subject has early-stage age-related macular degeneration or excessive drusen pre-age-related macular degeneration and the therapeutically effective amount of antibody or antigen binding fragment thereof is an amount of antibody or antigen binding fragment thereof effective to inhibit onset of age-related macular degeneration.

### Claim 92

A method of treating ocular disorders in a subject in need thereof, comprising administering to the subject undergoing anti-VEGF, anti-PDGF treatment a therapeutically effective amount of an anti-Bb antibody or antigen binding fragment thereof that binds to a component of alternative pathway and inhibits alternative pathway activation, wherein the anti-Bb antibody or antigen binding fragment thereof includes a light chain variable domain including 3CDRs of SEQ ID NO: 36 and a heavy chain variable domain including 3CDRs of SEQ ID NO: 79.

### Claim 93 (depends on 92)

The method of claim 92, wherein the antibody or antigen binding fragment thereof has a reduced effector function.

### Claim 94 (depends on 92)

The method of claim 92, wherein the antibody is a hybrid of two antibody isoforms.

### Claim 95 (depends on 92)

The method of claim 92, wherein the antibody or antigen binding fragment thereof binds to a component of alternative pathway C3 convertase and inhibits alternative pathway activation.

### Claim 96 (depends on 92)

The method of claim 92, wherein the antibody or antigen binding fragment thereof selectively inhibits C3a, C5a, C3b, C5b, and C5b-9 produced by the alternative pathway but not the classical pathway.
