US 12,156,942 B2
Sustained delivery of therapeutic agents to an eye compartment
Peter J. McDonnell, Baltimore, MD (US); Yasin A. Khan, Baltimore, MD (US); Samuel K. Lai, Chapel Hill, NC (US); Renata T. Kashiwabuchi, Baltimore, MD (US); Ashley Behrens, Baltimore, MD (US); and Justin S. Hanes, Baltimore, MD (US)
Assigned to THE JOHNS HOPKINS UNIVERSITY, Baltimore, MD (US)
Filed by The Johns Hopkins University, Baltimore, MD (US)
Filed on Sep. 15, 2021, as Appl. No. 17/475,528.
Application 17/475,528 is a continuation of application No. 16/502,359, filed on Jul. 3, 2019, abandoned.
Application 16/502,359 is a continuation of application No. 15/884,158, filed on Jan. 30, 2018, granted, now 10,369,107, issued on Aug. 6, 2019.
Application 15/884,158 is a continuation of application No. 15/138,132, filed on Apr. 25, 2016, granted, now 9,937,130, issued on Apr. 10, 2018.
Application 15/138,132 is a continuation of application No. 14/521,904, filed on Oct. 23, 2014, granted, now 9,566,242, issued on Feb. 14, 2017.
Application 14/521,904 is a continuation of application No. 13/581,454, granted, now 8,889,193, issued on Nov. 18, 2014, previously published as PCT/US2011/026321, filed on Feb. 25, 2011.
Claims priority of provisional application 61/308,035, filed on Feb. 25, 2010.
Claims priority of provisional application 61/308,042, filed on Feb. 25, 2010.
Claims priority of provisional application 61/308,053, filed on Feb. 25, 2010.
Prior Publication US 2022/0142924 A1, May 12, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/16 (2006.01); A61K 9/00 (2006.01); A61K 9/50 (2006.01); A61K 9/51 (2006.01); A61K 31/519 (2006.01); A61K 31/52 (2006.01); A61K 45/06 (2006.01); A61K 47/58 (2017.01); A61K 47/60 (2017.01); A61K 47/69 (2017.01)
CPC A61K 9/1676 (2013.01) [A61K 9/0048 (2013.01); A61K 9/0051 (2013.01); A61K 9/1641 (2013.01); A61K 9/1647 (2013.01); A61K 9/5026 (2013.01); A61K 9/5031 (2013.01); A61K 9/5146 (2013.01); A61K 9/5153 (2013.01); A61K 31/519 (2013.01); A61K 31/52 (2013.01); A61K 45/06 (2013.01); A61K 47/58 (2017.08); A61K 47/60 (2017.08); A61K 47/6921 (2017.08); A61K 47/6931 (2017.08)] 26 Claims
 
1. An injectable composition for administration to the eye of a patient in need thereof, comprising a drug delivery system that comprises:
i) microparticles having a diameter of 30 μm or less including a core comprising the biodegradable polymer polylactide-co-glycolide or polylactide;
ii) a coating non-covalently associated with the microparticles, wherein the coating is formed of molecules having a polyethylene glycol hydrophilic region and a hydrophobic region;
iii) a therapeutically effective amount of a therapeutic agent for intraocular efficacy over a period of at least three months;
iv) in a sterile suspension suitable for delivery into the eye;
wherein the drug delivery system provides sustained release of a therapeutically effective amount of the therapeutic agent into the eye of the patient over a period of time of at least three months, and
wherein the eye exhibits at least 10% less inflammation or intraocular pressure than if the particles were uncoated, for at least about 30 days post-intraocular administration.