Ophthalmologic irrigation solutions and method

a technology for ophthalmologic irrigation and solutions, applied in the direction of anti-noxious agents, drug compositions, peptide/protein ingredients, etc., can solve the problems of reducing the therapeutic efficacy of the agent, not always providing a defined dosage method, etc., to reduce the side effects of ocular therapy, increase the efficacy, and reduce the intraocular pressure

Inactive Publication Date: 2004-04-15
OMEROS CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

0018] The present invention provides for controlled, site-specific drug delivery to the eye for the dual purposes of increasing efficacy and decreasing side effects of ocular therapy. A therapeutic concentration range is rapidly achieved, and is subsequently maintained at an effectively constant level during the period of irrigation.
0019] The present invention also provides a method for manufacturing a medicament compounded as a dilute irrigation solution for use in continuously irrigating an operative site or wound during an operative procedure. The method entails dissolving in a physiologic electrolyte carrier fluid a plurality of analgesic agents, anti-inflammatory agents, mydriatic agents, and/or agents that decrease intraocular pressure ("IOP reducing agents"), each agent included at a concentration of preferably no more than 100,000 nanomolar, and more preferably no more than 10,000 nanomolar, except for local anesthetics, which may be applied at a concentration of no more than 100,000,000 nanomolar, preferably no more than 10,000,000 nanomolar, more preferably no more than 1,000,000 nanomolar, and still more preferably no more than 100,000 nanomolar.
0020] The method of the present invention provides for the delivery of a dilute combination of multiple receptor antagonists and agonists and enzyme inhibitors and activators directly to a wound or operative or procedural site of the eye, during surgical, therapeutic or diagnostic procedures for the inhibition of pain and inflammation, reduction or control of intraocular pressure, and/or the promotion of mydriasis. Because the active ingredients in the solut

Problems solved by technology

Liquid compositions for topical drop-wise instillation of a pharmaceutical agent to the eye do not always provide an accurate method for delivering a defined dosage, because portions of the drop are either blinked away or drain away during administration.
Furthermore, subsequent use of

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0095] Exemplary ophthalmologic solutions of the present invention for use during cataract removal surgery are described in Tables 20, 21 and 22. This solution, and the following solutions of Tables 23-25, are provided by way of example only, and are not intended to limit the invention. Anti-inflammatories are believed to be particularly useful in cataract solutions of the invention, to potentially reduce the post-operative incidence of, or hasten resolution of, cystoid macular edema (CME). These exemplary solutions and the other exemplary ophthalmologic irrigation solutions described herein below are provided in terms of the concentration of each agent included in the previously described preferred balanced-salt solution. The solution may suitably be supplied in 500 ml bags, this being the quantity of irrigation solution typically applied during a procedure, by way of non-limiting example.

20TABLE 20 Exemplary Cataract Solution Concentration Class of (Nanomolar): Most Agent Drug The...

example 2

[0098] A similar irrigation solution including multiple agents for effective reduction of inflammation and to provide mydriasis for invasive ophthalmologic surgery, such as a trabeculectomy, is provided in Table 23.

23TABLE 23 Exemplary Trabeculectomy Solution Concentration Class (Nanomolar): Most of Agent Drug Therapeutic Preferred Preferred anti- prednis-10-1,000,000 100-100,000 1,000-10,000 inflam- olone matory anti- flurbi- 10-1,000,000 100-100,000 1,000-10,000 inflam-profen matory IOP red. timolol 10-1,000,000 100-100,000 1,000-10,000 agent mydriatic phenyle- 50-500,000 500-100,000 1,000-10,000 phrine

example 3

[0099] Irrigation solutions suitably used for extensive ophthalmologic surgery or posterior ocular chamber procedures, such as vitrectomy, provide increased analgesia by the addition of a local anesthetic. Such solutions of the present invention including a local anesthetic are provided in Tables 24 and 25.

24TABLE 24 Exemplary Local Anesthetic Ophthalmologic Solution Concentration Class (Nanomolar): Most of Agent Drug Therapeutic Preferred Preferred IOP red. timolol 10-1,000,000 100-100,000 1,000-10,000 agent anti- flurbi- 10-1,000,000 100-100,000 1,000-10,000 inflam- profen matory mydriatic tropica- 10-1,000,000 100-100,000 1,000-10,000 mide analgesic lidocaine 1,000-10,000- 100,000- 100,000,000 10,000,000 1,000,000

[0100]

25TABLE 25 Alternate Exemplary Local Anesthetic Ophthalmologic Solution Concentration Class of (Nanomolar): Most Agent Drug Therapeutic Preferred Preferred IOP red. timolol 10-1,000,000 100-100,000 1,000-10,000 agent anti- flurbi- 10-1,000,000 100-100,000 1,000-10,...

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Abstract

Solutions for perioperative intraocular application by continuous irrigation during ophthalmologic procedures are provided. These solutions include multiple agents that act to inhibit inflammation, inhibit pain, effect mydriasis (dilation of the pupil), and/or decrease intraocular pressure, wherein the multiple agents are selected to target multiple molecular targets to achieve multiple differing physiologic functions, and are included in dilute concentrations in a balanced salt solution carrier.

Description

I. CROSS REFERENCE TO RELATED APPLICATIONS[0001] The present invention claims the benefit of the filing date of U.S. Provisional Application No. 60 / 399,899, filed Jul. 30, 2002.II. FIELD OF THE INVENTION[0002] The present invention relates to surgical irrigation solutions and methods, and particularly to irrigation solutions for use during ophthalmologic procedures.III. BACKGROUND OF THE INVENTION[0003] Ophthalmologic surgery typically requires the use of a physiologic irrigation solution to protect and maintain the physiological integrity of intraocular tissues. Examples of ophthalmologic surgical procedures usually requiring irrigation solutions are cataract operations, corneal transplant operations, vitreoretinal operations and trabeculectomy operations for glaucoma.[0004] Solutions that have been used in ophthalmologic surgical irrigation include normal saline, lactated Ringer's solution and Hartmann's lactated Ringer's solution, but these are not optimal due to potential unfavo...

Claims

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Application Information

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IPC IPC(8): A61FA61K9/00A61K31/00A61K31/19A61K31/192A61K31/485A61K31/56A61K31/573A61K38/00A61K45/06
CPCA61K31/573A61K9/0048A61K31/5377A61K45/06A61K31/4409A61K31/445A61K31/4164A61K31/137A61K31/4174A61K31/00A61K31/192A61K31/167A61P23/00A61P23/02A61P25/02A61P25/04A61P27/02A61P27/04A61P27/08A61P27/12A61P29/00A61P29/02A61P39/06A61P41/00A61P43/00A61K9/08
Inventor DEMOPULOS, GREGORY A.PALMER, PAMELA PIERCEHERZ, JEFFREY M.
Owner OMEROS CORP
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