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US 2019/0100582 A1Published application
Compositions and methods for reducing ocular neovascularization
AssigneeAdverum Biotechnologies, Inc.
InventorsMark BLUMENKRANZ, Mehdi GASMI
Life of this patent
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Abstract
The present disclosure provides pharmaceutical compositions and methods thereof for the prevention or treatment of ocular neovascularization, such as AMD, in a subject, by administering to the subject a pharmaceutical composition comprising a rAAV vector having a nucleic acid sequence that encodes an anti-VEGF agent.
Claims26
1:
- A method of treating an eye disease or condition, the method comprising administering a unit dose of a pharmaceutical composition by intravitreal injection to an eye of a primate subject in need thereof, wherein the pharmaceutical suspension comprises:
- (a) a rAAV2 variant comprising an amino acid sequence LGETTRP (SEP ID NO:
- 1) inserted between positions 587 and 588 of capsid protein VP1, a nucleic acid comprising a sequence having at least 95% homology to SEQ ID NO:
- 9 and a sequence having at least 95% homology to SEQ ID NO:
- 10, and
- (b) a pharmaceutical acceptable excipient.
3 more elements
2:
- The method of claim 1, wherein the unit dose is between 2E12 to 6E12 vector genomes.
(canceled)
4:
- The method of claim 1, wherein the subject is a human.
5:
- The method of claim 1, wherein the eye condition or disease is neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema (DME), retinal vein occlusion, or diabetic retinopathy associated with DME.
6:
- The method of claim 1, wherein the eye condition or disease is choroidal neovascularization or AMD.
7:
- The method of claim 1, wherein administering the suspension results in a reduction in percentage of grade IV lesions by at least 5% as compared to a vehicle control, as measured by color fundus photography.
8:
- The method of claim 7, wherein the reduction in percentage of grade IV lesions is at least 10%.
9:
- The method of claim 1, wherein the unit dose comprises has a volume that is not more than 100 μL.
10:
- The method of claim 1, wherein the unit dose comprises has a volume that is not more than 50 μL.
(canceled)
12:
- The method of claim 1, wherein the subject is responsive to at least one of ranibizumab, bevacizumab, and sVEGFR-1.
13:
- The method of claim 1, wherein the subject has been pre-treated with ranibizumab or bevacizumab.
14-15. (canceled)
16:
- The method of claim 1, wherein the administering by injection occurs not more than once in at least 2 years.
17:
- The method of claim 1, wherein the administering by injection occurs not more than once in at least 5 years.
18:
- The method of claim 1, wherein the administering is a one-time administration.
19:
- The method of claim 1, further comprising agitating the suspension to ensure even distribution prior to the administering step.
20:
- The method of claim 1, further comprising warming the suspension to room temperature prior to the administering step.
21:
- The method of claim 1, wherein the suspension further comprises a surfactant.
22:
- The method of claim 21, wherein the surfactant is selected from polysorbates, sodium dodecyl sulfate, sodium lauryl sulfate, lauryl dimethyl amine oxide, polyethoxylated alcohols, polyoxyethylene sorbitan, octoxynol, Brij, pluronic, and polyoxyl castor oil.
23:
- The method of claim 1, wherein the suspension further comprises phenol, mannitol, sorbitol, or sodium chloride.
24:
- The method of claim 1, further comprising administering an antibiotic solution or an atropine sulfate ointment after the injection.
25:
- The method of claim 24, wherein the antibiotic solution comprises ciprofloxacin.
26-67. (canceled)
68:
- The method of claim 1, wherein the rAAV2 variant comprises a nucleic acid comprising the sequence of SEQ ID NO:
- 9 and the sequence of SEQ ID NO:
- 10.
Dependencies are inferred from the claim text.