JPWO2020081941A5 - - Google Patents

Claims (20)

A composition for treating ophthalmic diseases/disorders or injuries associated with neurodegenerative diseases/disorders or neuro-ophthalmic disorders in a human patient in need thereof , comprising ibudilast or a pharmaceutically acceptable A composition comprising salt. 2. The composition of claim 1, wherein said eye disease/disorder or injury is macular injury. 2. The composition of claim 1, wherein said neurodegenerative disease/disorder is progressive multiple sclerosis. 4. The composition of claim 3, wherein administration results in a reduction in macular volume loss associated with progressive multiple sclerosis in said human patient . 5. Said administration of said ibudilast or a pharmaceutically acceptable salt thereof reduces macular volume loss in said human patient compared to no administration of said ibudilast or a pharmaceutically acceptable salt thereof. The composition according to . The composition of any one of claims 3-5, wherein the progressive multiple sclerosis has progressed beyond relapsing-remitting multiple sclerosis. A composition according to any one of claims 3 to 5, wherein the progressive multiple sclerosis is primary progressive multiple sclerosis. 8. The composition of claim 7, wherein the primary progressive multiple sclerosis is characterized by disease progression from onset with occasional stagnation and transient minor improvements, but not discrete relapses. . A composition according to any one of claims 3 to 5, wherein said progressive multiple sclerosis is secondary progressive multiple sclerosis. Said secondary progressive multiple sclerosis is characterized as an early relapsing-remitting course followed by progression, with or without occasional relapses, mild remissions and stagnation. Item 9. The composition of Item 9. 6. The composition of any one of claims 1-5, wherein the ibudilast or a pharmaceutically acceptable salt thereof is administered for at least about 12, 24, 36, 48, 60, 72, 84, or 96 weeks. things . 6. The composition of any one of claims 1-5, wherein the ibudilast or a pharmaceutically acceptable salt thereof is administered for at least about 1 year, 2 years, 3 years, 4 years, or 5 years. The composition of any one of claims 1-5, wherein the ibudilast or a pharmaceutically acceptable salt thereof is administered orally. 14. The composition of claim 13 , wherein the ibudilast or a pharmaceutically acceptable salt thereof is administered in a tablet, capsule, or microbead dosage form. 14. The composition of Claim 13 , wherein the ibudilast or a pharmaceutically acceptable salt thereof is administered in a liquid dosage form. 6. The composition of any one of claims 1-5, wherein the ibudilast or a pharmaceutically acceptable salt thereof is formulated as a sustained release formulation. 6. The composition of any one of claims 1-5, wherein the ibudilast or a pharmaceutically acceptable salt thereof is administered in an amount of about 0.1 mg/day to about 4,000 mg/day. 6. The composition of any one of claims 1-5, wherein the ibudilast or a pharmaceutically acceptable salt thereof is administered in an amount of about 60 mg/day to about 600 mg/day. The ibudilast or a pharmaceutically acceptable salt thereof is about 30 mg/day, about 60 mg/day, about 80 mg/day, about 90 mg/day, about 100 mg/day, about 120 mg/day, about 150 mg/day, about 180 mg /day, about 210 mg/day, about 240 mg/day, about 270 mg/day, about 300 mg/day, about 360 mg/day, about 400 mg/day, about 440 mg/day, about 480 mg/day, about 520 mg/day, about 580 mg 600 mg/day, about 620 mg/day, about 640 mg/day, about 680 mg/day, or about 720 mg/day . . 18. The composition of claim 17 , wherein the amount of ibudilast or a pharmaceutically acceptable salt thereof administered daily is divided into one, two, or three portions.