Treatment of ocular neovascularization using anti-vegf proteins
AssigneeAvalanche Australia Pty Ltd.
InventorsIan J. Constable, P. Elizabeth Rakoczy, Chooi-May Lai, Thomas W. Chalberg, Jr.
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Abstract
The present disclosure provides compositions and methods for the prevention or treatment of ocular neovascularization, such as AMD, in a human subject, by administering subretinally a pharmaceutical composition comprising a pharmaceutically effective amount of a vector comprising a nucleic acid encoding soluble Fms-related tyrosine kinase-1 (sFlt-1) protein to the human subject.
Claims24
A method for the treatment of ocular neovascularization in a human subject suffering from ocular neovascularization, the method comprising:
- i) administering a first dose of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent to the human subject;
- ii) within 90 days of administering the anti-VEGF agent to the eye according to step (i), administering to the eye of the human subject a single unit dose of a pharmaceutical composition comprising a recombinant adeno-associated virus (rAAV) comprising a nucleic acid sequence encoding an anti-VEGF protein, wherein the anti-VEGF protein comprises a polypeptide selected from the group consisting of (a) a polypeptide having at least 90% identity to SEQ ID NO:
- 121 and (b) a polypeptide having at least 90% identity to SEQ ID NO:
- 121 plus a domain 3, wherein the domain 3 is selected from domain 3 of sFLT and domain 3 of KDR, wherein the single unit dose comprises at least 1×106 and at most 1×1015 vector genomes of the rAAV;
- and
- iii) administering a second dose of an anti-VEGF agent within 30 days post administration of the rAAV.
A unit dose of a pharmaceutical composition for use in a method for the treatment of an ocular neovascular disease in a human subject having ocular neovascularization, the unit dose comprising recombinant adeno-associated viruses (rAAVs) of 1×1010 to 3×1012 vector genomes of the rAAV, wherein the recombinant viruses comprise a promoter operatively linked to a nucleic acid sequence encoding an anti-VEGF protein, wherein the anti-VEGF protein comprises a polypeptide selected from the group consisting of (a) a polypeptide having at least 90% identity to SEQ ID NO:
- 121 and (b) a polypeptide having at least 90% identity to SEO ID NO:
- 121 plus a domain 3, wherein domain 3 is selected from domain 3 of sFLT and domain 3 of KDR, wherein the human subject has previously received a first intravitreal injection of an anti-Vascular Endothelial Growth Factor (VEGF) agent in an amount such that the anti-VEGF agent is present in the eye of the subject at a concentration sufficient to prevent progression of the neovascularization at the time of administration of the unit dose.
Dependencies are inferred from the claim text.