Anti-inflammatory and mydriatic intracameral solutions for inhibition of postoperative ocular inflammatory conditions

a technology of ocular inflammatory conditions and intracameral solutions, which is applied in the direction of sense disorder, organic active ingredients, drug compositions, etc., can solve the problems of increased risk of injuring eye structures, increased risk of eye injury, so as to promote mydriasis, and inhibit a postoperative inflammatory condition

Inactive Publication Date: 2016-09-29
OMEROS CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0017]The present invention also provides a method for inhibiting a postoperative inflammatory condition following an ophthalmologic surgical procedure by identifying a subject with a physiologic risk of suffering from a postoperative inflammatory condition and administering intraocularly to the subject during an ophthalmologic surgical procedure a solution including a nonsteroidal anti-inflammatory drug (NSAID) and an alpha-1 adrenergic receptor agonist mydriatic agent in an intraocular irrigation carrier, wherein the NSAID and the mydriatic agent are included in the solution in amounts sufficient for the maintenance of intraoperative pupil diameter due to the intraoperative promotion of mydriasis by the mydriatic agent and the intraoperative inhibition of miosis by the NSAID, thereby reducing intraoperative trauma, and for the inhibition of the postoperative inflammatory condition by the intraoperative and postoperative anti-inflammatory effect of the NSAID.

Problems solved by technology

Ophthalmologic surgery necessarily results in trauma to delicate intraocular structures that induces prostaglandin synthesis and the inflammatory cascade.
The resulting inflammation can result in the occurrence of excess inflammation and associated postoperative inflammatory conditions, particularly in subjects having a preoperative condition placing them at elevated risk for postoperative inflammatory conditions or that may experience an elevated level of surgical trauma.
If pupil diameter is not maintained adequately throughout the procedure, the risk of injuring structures within the eye increases and the required operating time is often prolonged.
Clinically significant reductions in pupil diameter are associated with an increase in procedure-related complications, including posterior capsule tears, retained lens fragments and vitreous leaks.
This approach to miosis prevention is not optimal because intraoperative irrigation solution washes out preoperatively delivered agents from the areas within the eye that are bathed by the irrigation solution.

Method used

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  • Anti-inflammatory and mydriatic intracameral solutions for inhibition of postoperative ocular inflammatory conditions
  • Anti-inflammatory and mydriatic intracameral solutions for inhibition of postoperative ocular inflammatory conditions
  • Anti-inflammatory and mydriatic intracameral solutions for inhibition of postoperative ocular inflammatory conditions

Examples

Experimental program
Comparison scheme
Effect test

example 1

Clinical Studies Evaluating Phenylephrine 1% / Ketorolac 0.3% in Cataract Surgery and Intraocular Lens Replacement for Maintenance of Mydriasis and Prevention of Postoperative Pain

[0077]This example describes two Phase 3 clinical studies performed to evaluate the efficacy and safety of phenylephrine 1% and ketorolac 0.3% injection formulated as described in Table 1 above when used for the maintenance of mydriasis during, and prevention of postoperative pain following, cataract surgery and intraocular lens (IOL) replacement.

[0078]Methods

[0079]Two pivotal, multi-center, randomized, parallel-group, double-masked, placebo-controlled phase 3 studies (Study 1 and Study 2) that were conducted to support the use of phenylephrine 1% and ketorolac 0.3% injection (OMS302) for maintaining intraoperative mydriasis, preventing intraoperative miosis, and reducing early postoperative ocular pain associated with cataract surgery and IOL replacement. A total of 20 sites in the United States and Netherl...

example 2

Ocular Tissue Distribution of Ketorolac Following Administration of Phenylephrine 1% / Ketorolac 0.3% to Dogs During Intraocular Lens Replacement

[0098]This example describes the results of an in vivo study in dogs to determine the concentrations of ketorolac in the retina and other ocular tissues following the intracameral administration of phenylephrine 1% and ketorolac 0.3% injection formulated as described in Table 1 (OMS302) during IOL replacement in dogs.

[0099]Methods

[0100]IOL replacement by phacoemulsification was performed on 20 female beagles. During the procedure, OMS302 was administered in BSS solution via irrigation and intracameral injection immediately post-procedure. The target dose level of ketorolac was 5.71 mg / eye, and the target dose volume of OMS302 diluted in BSS solution was 250 mL per eye. Four animals per time point were sacrificed at 0, 2, 6, 8, and 10 hours post-procedure. Samples of blood and aqueous humor were collected. Enucleated eyes were frozen and disse...

example 3

Clinical Study Evaluating Intracameral Ketorolac Concentration Following Topical Ketorolac Administration Prior to Cataract Surgery

[0105]This example describes the results of a clinical study to determine postoperative intracameral concentrations of ketorolac in subjects receiving topical ketorolac prior to cataract surgery.

[0106]Methods

[0107]Patients undergoing cataract extraction and lens replacement (CELR) were eligible. Written informed consent was obtained from 14 subjects, each of whom received topical ophthalmic ketorolac according to the surgeon's usual practice, beginning one day preoperatively. Immediately prior to the initial surgical incision, the surgeon withdrew a 100-μL sample of aqueous humor from the operative eye with a 30-gauge tuberculin syringe. At the conclusion of CELR prior to final re-inflation of the anterior chamber and wound closure, the surgeon withdrew another 100-μL sample from the anterior chamber. The ketorolac concentrations of the intracameral flui...

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Abstract

The present invention provides methods for inhibiting postoperative inflammatory conditions following ophthalmologic surgical procedures by administering intraocularly during an ophthalmologic surgical procedure a solution including a nonsteroidal anti-inflammatory agent and an alpha-1 adrenergic mydriatic agent, such as a liquid irrigation solution of ketorolac and phenylephrine.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]The present invention claims the benefit of the filing date of U.S. Provisional Application No. 62 / 086,133 filed Dec. 1, 2014.I. FIELD OF THE INVENTION[0002]The present invention relates to methods of using liquid pharmaceutical compositions including a nonsteroidal anti-inflammatory agent and an alpha-adrenergic mydriatic agent for intraocular administration during an ophthalmologic surgical procedure to inhibit postoperative inflammatory conditions.II. BACKGROUND OF THE INVENTION[0003]Ophthalmologic surgery necessarily results in trauma to delicate intraocular structures that induces prostaglandin synthesis and the inflammatory cascade. The resulting inflammation can result in the occurrence of excess inflammation and associated postoperative inflammatory conditions, particularly in subjects having a preoperative condition placing them at elevated risk for postoperative inflammatory conditions or that may experience an elevated level of ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/407A61K31/137A61K9/00
CPCA61K31/407A61K31/137A61K9/0048A61K31/405A61K31/192A61K31/4174A61P27/02A61P27/08A61P27/12A61P29/00A61P31/22A61P43/00A61K2300/00A61K31/196A61K9/08A61K31/138
Inventor DEMOPULOS, GREGORY A.FLORIO, VINCENT A.
Owner OMEROS CORP
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