US 12,263,160 B2
Methods of treating ocular inflammatory diseases
Elizabeth W. Jeffords, Hillsborough, CA (US); Hovhannes John Gukasyan, Orange, CA (US); Rozemarijn Verhoeven, Siler City, NC (US); Houman David Hemmati, Santa Monica, CA (US); Daniel J. Estes, San Diego, CA (US); and Richard Graham, Irvine, CA (US)
Assigned to IOLYX THERAPEUTICS, INC., Burlingame, CA (US)
Filed by Iolyx Therapeutics, Inc., Burlingame, CA (US)
Filed on Sep. 22, 2022, as Appl. No. 17/950,802.
Claims priority of provisional application 63/247,174, filed on Sep. 22, 2021.
Claims priority of provisional application 63/251,874, filed on Oct. 4, 2021.
Prior Publication US 2023/0090417 A1, Mar. 23, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/4468 (2006.01); A61K 31/335 (2006.01); A61K 31/573 (2006.01); A61P 27/02 (2006.01)
CPC A61K 31/4468 (2013.01) [A61K 31/335 (2013.01); A61K 31/573 (2013.01); A61P 27/02 (2018.01)] 21 Claims
 
1. A method for treating a patient having an ocular inflammatory or immune-mediated disorder, comprising:
administering a stable ophthalmic pharmaceutical suspension comprising a therapeutically effective amount of between 0.1% w/v to 3.0% w/v of roflumilast or a pharmaceutically acceptable salt thereof, an amount of a viscosity agent between 0.1% w/v and 5.0% w/v, an amount of a surfactant between 0.05% w/v and 3.0% w/v, and an amount of a buffer between 0.1% w/v and 5.0% w/v to an ocular surface of said patient,
wherein said administration results in a reduction of at least one side effect relative to administration of an immunosuppressant, immunomodulatory, or a non-steroidal anti-inflammatory agent,
wherein a pH of said stable ophthalmic pharmaceutical suspension is between 6.0 and 6.7.