Extended, High Dose VEGF Antagonist Regimens for Treatment of Angiogenic Eye Disorders
AssigneesRegeneron Pharmaceuticals, Inc., Bayer HealthCare LLC
InventorsRobert L. Vitti, Alyson J. Berliner, Karen W. Chu, Friedrich Asmus, Sergio Casimiro da Silva Leal, Thomas Eißing, Kay D. Rittenhouse
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Abstract
The present invention relates to regimens for the treatment of angiogenic eye disorders such as nAMD, DR and DME characterized by high doses of aflibercept extended periods between doses.
Claims63
A method
- for treating an angiogenic eye disorder in a subject in need thereof,
- for improving best corrected visual acuity in a subject in need thereof with an angiogenic eye disorder;
- or
- for promoting retinal drying in a subject with an angiogenic eye disorder in need thereof;
- comprising administering to an eye of the subject, one or more doses of about 8 mg (±0.8 mg) or more of VEGF receptor fusion protein about once every 8-24, 12-24, 16-24, 20-24, 21-24, 21, 22, 23 or 24 weeks.
A method for slowing the clearance of free aflibercept from the ocular compartment after an intravitreal injection relative to the rate of clearance of aflibercept from the ocular compartment after an intravitreal injection of 2 mg or ≤4 mg aflibercept comprising intravitreally injecting into an eye of a subject in need thereof,
- a single initial dose of about 8 mg (±0.8 mg) or more of aflibercept, followed by
- one or more secondary doses of about 8 mg (±0.8 mg) or more of the aflibercept, followed by
- one or more tertiary doses of about 8 mg (±0.8 mg) or more of the aflibercept;
- wherein each secondary dose is administered about 2 to 4 weeks after the immediately preceding dose;
- and
- wherein each tertiary dose is administered about 8-24, 12-24, 16-24, 20-24, 21-24, 21, 22, 23 or 24 weeks after the immediately preceding dose.
6-7. (canceled)
A method for increasing the duration of efficacy and/or the time for the amount of free aflibercept to reach the lower limit of quantitation (LLOQ) in the ocular compartment of a subject after an intravitreal injection of aflibercept, relative to the time to reach LLOQ of the amount of free aflibercept in the ocular compartment of a subject after an intravitreal injection of about 2 mg or ≤4 mg aflibercept, comprising intravitreally injecting into an eye of a subject in need thereof,
- a single initial dose of about 8 mg (±0.8 mg) or more of aflibercept, followed by
- one or more secondary doses of about 8 mg (±0.8 mg) or more of the aflibercept, followed by
- one or more tertiary doses of about 8 mg (±0.8 mg) or more of the aflibercept;
- wherein each secondary dose is administered about 2 to 4 weeks after the immediately preceding dose;
- and
- wherein each tertiary dose is administered about 8-24, 12-24, 16-24, 20-24, 21-24, 21, 22, 23 or 24 weeks after the immediately preceding dose.
9-12. (canceled)
A method for increasing the time for free aflibercept to reach the lower limit of quantitation (LLOQ) in the plasma of a subject after an intravitreal injection of aflibercept relative to the time to reach LLOQ of free aflibercept in the plasma of a subject after an intravitreal injection of about 2 or ≤4 mg aflibercept, comprising intravitreally injecting into an eye of a subject in need thereof,
- a single initial dose of about 8 mg (±0.8 mg) or more of aflibercept, followed by
- one or more secondary doses of about 8 mg (±0.8 mg) or more of the aflibercept, followed by
- one or more tertiary doses of about 8 mg (±0.8 mg) or more of the aflibercept;
- wherein each secondary dose is administered about 2 to 4 weeks after the immediately preceding dose;
- and
- wherein each tertiary dose is administered about 8-24, 12-24, 16-24, 20-24, 21-24, 21, 22, 23 or 24 weeks after the immediately preceding dose.
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Dependencies are inferred from the claim text.