Use of sustained release dexamethasone in post-cataract surgery inflammation
Inventors
Wong, Vernon G. • White, William S. • Hu, Mae W. • Huang, Glenn T. • Karasina, Faina
Assignees
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Publication Number
US-10028965-B2
Publication Date
2018-07-24
Expiration Date
Abstract
The present embodiments provide for a treatment regimen and use of a short-term sustained release liquid formulation of dexamethasone in citrate, wherein a single administration of a minute dosage form into the anterior chamber of the eye provides for anti-inflammatory therapy following cataract surgery.
Core Innovation
The disclosure relates to post-cataract-surgery treatment of inflammation of an eye by administering a single intraocular injection of a formulation consisting essentially of dexamethasone in triethyl acetyl citrate. The administration is performed after completion of cataract surgery by injecting about 4 µL to about 6 µL of a single dose into the eye, with a specific exemplary single dose described as about 517 µg dexamethasone in triethyl acetyl citrate.
The formulation is characterized by sustained release of dexamethasone for at least 3 days as measured in saline solution under infinite sink conditions. Additional described release and retention characteristics include dexamethasone release for at least 7 days and no more than 35 days in the same test conditions, and retention of at least 30% of dexamethasone after 3 days as measured in saline solution under infinite sink conditions.
The disclosure positions the approach as addressing post-cataract inflammation using an intraocular sustained-release dexamethasone formulation associated with measurable anti-inflammatory effects, including anterior chamber cell grading assessed by slit lamp biomicroscopy and clinical outcomes supported by Phase II trial results. The document also describes in vitro and in vivo release/performance data, including saline infinite-sink release kinetics and rabbit aqueous humor release duration.
Claims Coverage
The partial content provides one independent claim. The independent claim covers treating inflammation of an eye following cataract surgery using a single intraocular injection of a dexamethasone/triethyl acetyl citrate formulation with specified dose and release performance under infinite sink conditions, with dependent claims further narrowing the injection site, dose volume, release duration, retention, and anterior chamber cell efficacy criteria.
Single intraocular injection after cataract surgery
Following completion of cataract surgery on the eye, administering by injecting into the eye a single dose of about 4 µL to about 6 µL of a formulation consisting essentially of about 517 µg dexamethasone in triethyl acetyl citrate.
Sustained dexamethasone release under infinite sink conditions
The formulation releases said dexamethasone for at least 3 days as measured in saline solution under infinite sink conditions.
Overall, the claim coverage centers on a method that delivers post-cataract inflammation treatment via a single intraocular injection of a dexamethasone in triethyl acetyl citrate formulation with dose volume and dexamethasone release duration defined by saline infinite-sink measurements, and dependent claims further constrain anterior chamber injection, dose volume specificity, release-time window, dexamethasone retention after 3 days, and anterior chamber cell outcome thresholds.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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