Use of a VEGF antagonist to treat angiogenic eye disorders
The present invention provides methods for treating angiogenic eye disorders by sequentially administering multiple doses of a VEGF antagonist to a patient. The methods of the present invention include the administration of multiple doses of a VEGF antagonist to a patient at a frequency of once every 8 or more weeks. The methods of the present invention are useful for the treatment of angiogenic eye disorders such as age related macular degeneration, diabetic retinopathy, diabetic macular edema, central retinal vein occlusion, branch retinal vein occlusion, and corneal neovascularization.
1. A method of treating an angiogenic eye disorder in a patient in need thereof comprising sequentially administering to the patient a single initial dose of 2 mg of aflibercept, followed by two secondary doses of 2 mg of aflibercept followed by one or more tertiary doses of 2 mg of aflibercept;
wherein each secondary dose is administered to the patient by intravitreal injection approximately 4 weeks following the immediately preceding dose; and
wherein each tertiary dose is administered on an as needed or pro re nata (PRN) basis, based on visual or anatomic outcomes as assessed by a qualified medical professional;
wherein the patient achieves a gain in visual acuity within 52 weeks following the initial dose.
2. The method of claim 1 wherein the patient gains at least 8 letters Best Corrected Visual Acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
3. The method of claim 2 wherein the patient achieves the gain in visual acuity within 24 weeks following the initial dose.
4. The method of claim 1 wherein the patient gains at least 9 letters Best Corrected Visual Acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
5. The method of claim 4 wherein the patient achieves the gain in visual acuity within 24 weeks following the initial dose.
6. The method of claim 1 wherein the patient gains at least 10 letters Best Corrected Visual Acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
7. The method of claim 6 wherein the aflibercept is formulated as an isotonic solution.
8. The method of claim 7 wherein the isotonic solution contains a sugar.
9. The method of claim 6 wherein the aflibercept is formulated with a non-ionic surfactant.
10. The method of claim 6 wherein the patient achieves the gain in visual acuity within 24 weeks following the initial dose.
11. The method of claim 10 wherein the aflibercept is formulated as an isotonic solution.
12. The method of claim 11 wherein the isotonic solution contains a sugar.
13. The method of claim 10 wherein the aflibercept is formulated with a non-ionic surfactant.
14. The method of claim 1 , wherein each tertiary dose is administered on an as needed or pro re nata (PRN) basis, based on visual and anatomic outcomes as assessed by a qualified medical professional.
15. The method of claim 1 , wherein each tertiary dose is administered on an as needed or pro re nata (PRN) basis, based on visual outcomes as assessed by a qualified medical professional.
16. The method of claim 1 , wherein each tertiary dose is administered on an as needed or pro re nata (PRN) basis, based on anatomic outcomes as assessed by a qualified medical professional.
17. The method of claim 1 , wherein the qualified medical professional is a physician.
18. A method of treating diabetic macular edema in a patient in need thereof comprising sequentially administering to the patient a single initial dose of 2 mg of aflibercept, followed by one or more secondary doses of 2 mg of aflibercept, followed by one or more tertiary doses of 2 mg of aflibercept;
wherein each secondary dose is administered to the patient by intravitreal injection approximately 4 weeks following the immediately preceding dose; and
wherein each tertiary dose is administered on an as needed or pro re nata (PRN) basis, based on visual or anatomic outcomes as assessed by a qualified medical professional.
19. The method of claim 18 wherein the patient gains at least 9 letters Best Corrected Visual Acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score within 52 weeks following the initial dose.
20. The method of claim 19 wherein the patient achieves the gain in visual acuity within 24 weeks following the initial dose.
21. The method of claim 18 wherein the patient gains at least 10 letters Best Corrected Visual Acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score within 52 weeks following the initial dose.
22. The method of claim 21 wherein the aflibercept is formulated as an isotonic solution.
23. The method of claim 22 wherein the isotonic solution contains a sugar.
24. The method of claim 21 wherein the aflibercept is formulated with a non-ionic surfactant.
25. The method of claim 21 wherein the patient achieves the gain in visual acuity within 24 weeks following the initial dose.
26. The method of claim 25 wherein the aflibercept is formulated as an isotonic solution.
27. The method of claim 26 wherein the isotonic solution contains a sugar.
28. The method of claim 25 wherein the aflibercept is formulated with a non-ionic surfactant.
29. The method of claim 18 wherein exclusion criteria for the patient include both of:
(1) active ocular inflammation; and
(2) active ocular or periocular infection.
30. The method of claim 18 wherein four secondary doses are administered to the patient.
31. The method of claim 18 , wherein each tertiary dose is administered on an as needed or pro re nata (PRN) basis, based on visual and anatomic outcomes as assessed by a qualified medical professional.
32. The method of claim 18 , wherein each tertiary dose is administered on an as needed or pro re nata (PRN) basis, based on visual outcomes as assessed by a qualified medical professional.
33. The method of claim 18 , wherein each tertiary dose is administered on an as needed or pro re nata (PRN) basis, based on anatomic outcomes as assessed by a qualified medical professional.
34. The method of claim 18 , wherein the qualified medical professional is a physician.
35. A method of treating age-related macular degeneration in a patient in need thereof comprising sequentially administering to the patient a single initial dose of 2 mg of aflibercept, followed by one or more secondary doses of 2 mg of aflibercept, followed by one or more tertiary doses of 2 mg of aflibercept;
wherein each secondary dose is administered to the patient by intravitreal injection approximately 4 weeks following the immediately preceding dose; and
wherein each tertiary dose is administered on an as needed or pro re nata (PRN) basis, based on visual or anatomic outcomes as assessed by a qualified medical professional;
wherein the method is as effective in achieving a gain in visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose.
36. The method of claim 35 wherein only two secondary doses are administered to the patient.
37. The method of claim 35 wherein the gain in visual acuity is measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
38. The method of claim 35 , wherein each tertiary dose is administered on an as needed or pro re nata (PRN) basis, based on visual and anatomic outcomes as assessed by a qualified medical professional.
39. The method of claim 35 , wherein each tertiary dose is administered on an as needed or pro re nata (PRN) basis, based on visual outcomes as assessed by a qualified medical professional.
40. The method of claim 35 , wherein each tertiary dose is administered on an as needed or pro re nata (PRN) basis, based on anatomic outcomes as assessed by a qualified medical professional.
41. The method of claim 35 , wherein the qualified medical professional is a physician.