# US 11,744,908 B2 · Methods for determining biodistribution of intravitreal administered medicaments

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- Number: US 11,744,908 B2
- Document ID: US11744908B2
- Status: Granted
- Kind: B2
- Application number: 16/663,190
- Filed: 2019-10-24
- Published: 2020-04-30
- Granted: 2023-09-05
- Earliest claimed: 2018-10-25
- Applicants: John Christoforidis; Michael Knopp
- Inventors: John Christoforidis; Michael Knopp
- Web page: https://patentgrep.com/patent/US11744908B2

## CPC

- A61K 51/1021: {against cytokines, e.g. growth factors, VEGF, TNF, lymphokines or interferons}
- A61B 6/037: {Emission tomography}
- A61B 6/4057: {by using radiation sources located in the interior of the body (A61B6/037 takes precedence)}
- A61B 6/508: {for non-human patients}
- A61B 6/5235: {combining images from the same or different ionising radiation imaging techniques, e.g. PET and CT}
- A61K 51/12: characterised by a special physical form, e.g. emulsion, microcapsules, liposomes {, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules (liposomes A61K51/1234)}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Methods for determining systemic biodistribution characteristics of intravitrially administered medicaments. In some embodiments, radiolabeled agents or medicaments, such as I-124 labeled bevacizumab, ranibizumab and aflibercept, was imaged utilizing PET/CT in a non-human primate model, with radioactivity emission measurements made to determine the intravitreal half-lives of each agent and to determine the differences of radioactivity uptake in non-ocular organs.

## Claims

### Claim 1

A method for determining a systemic biodistribution of a radiolabeled intravitreally-placed medicament in a subject, the method comprising the steps of:
intraocularly placing a radiolabeled medicament including an anti-vascular endothelial growth factor (anti-VEGF) drug into the vitreous cavity of a subject's eye through the pars plana of the subject's eye; and
with a digital PET/CT (dPET/CT) apparatus, performing positron emission tomography (PET) imaging of radioactive emission of bodily parts that include the subject's eye and one or more of bladder, liver, heart, spleen, renal organs, and femur bones covered by a field-of-view of said dPET/PC apparatus, to quantify an uptake of said medicament containing the anti-VEGF drug systemically by said bodily parts to identify systemic side effects of the uptake of said medicament following the intraocularly placing.

### Claim 2 (depends on 1)

The method of claim 1, wherein said performing PET imaging includes
imaging with said dPET/CT apparatus a systemic biodistribution of a drug including one or more of bevacizumab, ranibizumab, and aflibercept in said bladder, liver, heart, spleen, renal organs, and femur bones.

### Claim 3 (depends on 1)

The method of claim 1, wherein said PET imaging is performed using a positron emission tomography/magnetic resonance imaging (PET/MRI) apparatus.

### Claim 4 (depends on 1)

The method of claim 1, wherein said subject is a mammal.

### Claim 5 (depends on 1)

The method of claim 1, wherein said subject is a non-human primate.

### Claim 6 (depends on 1)

The method of claim 1, wherein said performing PET imaging includes performing serial imaging of non-ocular organs within the field-of-view of said dPET/CT apparatus.

### Claim 7

A method for determining a biodistribution of a radiolabeled medicament containing an anti-vascular endothelial growth factor (anti-VEGF) drug in a subject, the method comprising the step of:
performing positron emission tomography (PET) imaging of radioactive emission of a subject's eye and one or more non-ocular organs within a field of view of a tomographer used for said imaging to identify systemic uptake of said anti-VGEF drug by the one or more non-ocular organs after intraocular placement of said radiolabeled medicament containing an anti-VEGF drug into the vitreous cavity of the subject's eye through the pars plana of the subject's eye.

### Claim 8 (depends on 7)

The method of claim 7, wherein said PET imaging is performed using a high-resolution digital PET/CT (dPET/CT) apparatus having a field-of-view covering the subject's eye and said one or more non-ocular organs that include one or more of bladder, liver, heart, spleen, renal organs, and femur bones.

### Claim 9 (depends on 7)

The method of claim 7, wherein said PET imaging is performed using a positron emission tomography/magnetic resonance imaging (PET/MRI) apparatus.

### Claim 10 (depends on 7)

The method of claim 7, wherein said subject is a mammal.

### Claim 11 (depends on 7)

The method of claim 7, wherein said subject is a non-human primate.

### Claim 12 (depends on 7)

The method of claim 7, wherein said performing PET imaging includes performing serial imaging.