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US 12,005,060 B2Granted
Ophthalmic formulations of methotrexate
AssigneeAldeyra Therapeutics, Inc.
InventorsDean Eliott, Stephen Gitu Machatha, Pramod Sarpotdar, Tomasz Stryjewski
Life of this patent
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Abstract
The present disclosure provides formulations of methotrexate for ocular administration, including intravitreal administration, and use of the formulations for treating proliferative vitreoretinopathy (PVR), intraocular lymphoma (e.g., PVRL), and intraocular inflammation.
Claims16
A composition suitable for intravitreal administration, comprising:
- methotrexate, a density enhancing agent, and a phosphate buffer, wherein the composition has a transit rate of less than 10 min in 1 mL of silicone oil (SiO) having a viscosity of at least 1000 centistoke and depth of 1 cm;
- the methotrexate is at a concentration of about 7 mg/mL to about 9 mg/mL, the density enhancing agent comprises sucrose at a concentration of about 7.0% w/v to about 8.0% w/v;
- the phosphate buffer is sodium phosphate dibasic dihydrate at a concentration of about 0.113 mg/mL to 0.142 mg/mL, and the composition is in a pre-filled syringe and has an administration volume of about 40 μL, about 45 μL, about 50 μL, or about 60 μL.
Dependencies are inferred from the claim text.