NZ732418B2 - Anti-inflammatory and mydriatic intracameral solutions for inhibition of postoperative ocular inflammatory conditions - Google Patents
Anti-inflammatory and mydriatic intracameral solutions for inhibition of postoperative ocular inflammatory conditions Download PDFInfo
- Publication number
- NZ732418B2 NZ732418B2 NZ732418A NZ73241815A NZ732418B2 NZ 732418 B2 NZ732418 B2 NZ 732418B2 NZ 732418 A NZ732418 A NZ 732418A NZ 73241815 A NZ73241815 A NZ 73241815A NZ 732418 B2 NZ732418 B2 NZ 732418B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- solution
- medicament
- ketorolac
- procedure
- phenylephrine
- Prior art date
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- 230000002980 postoperative effect Effects 0.000 title claims abstract 10
- 230000004968 inflammatory condition Effects 0.000 title claims abstract 8
- 230000005764 inhibitory process Effects 0.000 title claims 5
- 230000003110 anti-inflammatory effect Effects 0.000 title 1
- 230000002911 mydriatic effect Effects 0.000 title 1
- 238000001356 surgical procedure Methods 0.000 claims abstract 12
- OZWKMVRBQXNZKK-UHFFFAOYSA-N ketorolac Chemical compound OC(=O)C1CCN2C1=CC=C2C(=O)C1=CC=CC=C1 OZWKMVRBQXNZKK-UHFFFAOYSA-N 0.000 claims abstract 9
- 229960004752 ketorolac Drugs 0.000 claims abstract 9
- SONNWYBIRXJNDC-VIFPVBQESA-N phenylephrine Chemical compound CNC[C@H](O)C1=CC=CC(O)=C1 SONNWYBIRXJNDC-VIFPVBQESA-N 0.000 claims abstract 7
- 229960001802 phenylephrine Drugs 0.000 claims abstract 7
- 238000000034 method Methods 0.000 claims abstract 6
- 230000002401 inhibitory effect Effects 0.000 claims abstract 5
- 239000002637 mydriatic agent Substances 0.000 claims abstract 2
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 claims abstract 2
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 claims abstract 2
- 239000000243 solution Substances 0.000 claims 12
- 239000003814 drug Substances 0.000 claims 10
- 206010058202 Cystoid macular oedema Diseases 0.000 claims 4
- 208000001344 Macular Edema Diseases 0.000 claims 4
- 206010036346 Posterior capsule opacification Diseases 0.000 claims 4
- 201000010206 cystoid macular edema Diseases 0.000 claims 4
- 230000002262 irrigation Effects 0.000 claims 4
- 238000003973 irrigation Methods 0.000 claims 4
- 210000001747 pupil Anatomy 0.000 claims 3
- 108010037464 Cyclooxygenase 1 Proteins 0.000 claims 2
- 108010037462 Cyclooxygenase 2 Proteins 0.000 claims 2
- 206010027646 Miosis Diseases 0.000 claims 2
- 208000006550 Mydriasis Diseases 0.000 claims 2
- 239000004677 Nylon Substances 0.000 claims 2
- 102100038277 Prostaglandin G/H synthase 1 Human genes 0.000 claims 2
- 102100038280 Prostaglandin G/H synthase 2 Human genes 0.000 claims 2
- 102000004005 Prostaglandin-endoperoxide synthases Human genes 0.000 claims 2
- 108090000459 Prostaglandin-endoperoxide synthases Proteins 0.000 claims 2
- 206010039705 Scleritis Diseases 0.000 claims 2
- 206010046851 Uveitis Diseases 0.000 claims 2
- 230000000694 effects Effects 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
- 239000007924 injection Substances 0.000 claims 2
- 208000014674 injury Diseases 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 230000003547 miosis Effects 0.000 claims 2
- 229920001778 nylon Polymers 0.000 claims 2
- 230000001737 promoting effect Effects 0.000 claims 2
- 208000011580 syndromic disease Diseases 0.000 claims 2
- 230000008733 trauma Effects 0.000 claims 2
- 206010054045 Anterior capsule contraction Diseases 0.000 claims 1
- 208000024304 Choroidal Effusions Diseases 0.000 claims 1
- 208000004683 Corneal Endothelial Cell Loss Diseases 0.000 claims 1
- 206010011033 Corneal oedema Diseases 0.000 claims 1
- 206010012688 Diabetic retinal oedema Diseases 0.000 claims 1
- 206010012689 Diabetic retinopathy Diseases 0.000 claims 1
- 208000001351 Epiretinal Membrane Diseases 0.000 claims 1
- 206010015084 Episcleritis Diseases 0.000 claims 1
- 102000009123 Fibrin Human genes 0.000 claims 1
- 108010073385 Fibrin Proteins 0.000 claims 1
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 claims 1
- 206010016654 Fibrosis Diseases 0.000 claims 1
- 206010066373 Floppy iris syndrome Diseases 0.000 claims 1
- 206010061218 Inflammation Diseases 0.000 claims 1
- 206010022941 Iridocyclitis Diseases 0.000 claims 1
- 206010053675 Iris incarceration Diseases 0.000 claims 1
- 208000031471 Macular fibrosis Diseases 0.000 claims 1
- 206010063938 Posterior capsule rupture Diseases 0.000 claims 1
- 208000002367 Retinal Perforations Diseases 0.000 claims 1
- 206010066366 Toxic anterior segment syndrome Diseases 0.000 claims 1
- 206010063942 Vitreous loss Diseases 0.000 claims 1
- 206010047663 Vitritis Diseases 0.000 claims 1
- 230000001154 acute effect Effects 0.000 claims 1
- 201000009327 acute endophthalmitis Diseases 0.000 claims 1
- 239000000951 adrenergic alpha-1 receptor antagonist Substances 0.000 claims 1
- 210000002159 anterior chamber Anatomy 0.000 claims 1
- 201000004612 anterior uveitis Diseases 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 201000004778 corneal edema Diseases 0.000 claims 1
- 206010012601 diabetes mellitus Diseases 0.000 claims 1
- 201000011190 diabetic macular edema Diseases 0.000 claims 1
- 208000029436 dilated pupil Diseases 0.000 claims 1
- 206010014801 endophthalmitis Diseases 0.000 claims 1
- 238000000605 extraction Methods 0.000 claims 1
- 229950003499 fibrin Drugs 0.000 claims 1
- 230000004761 fibrosis Effects 0.000 claims 1
- 201000010884 herpes simplex virus keratitis Diseases 0.000 claims 1
- 208000013653 hyalitis Diseases 0.000 claims 1
- 201000009285 hypopyon Diseases 0.000 claims 1
- 230000002757 inflammatory effect Effects 0.000 claims 1
- 230000004054 inflammatory process Effects 0.000 claims 1
- GGXICVAJURFBLW-CEYXHVGTSA-N latanoprost Chemical compound CC(C)OC(=O)CCC\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1CC[C@@H](O)CCC1=CC=CC=C1 GGXICVAJURFBLW-CEYXHVGTSA-N 0.000 claims 1
- 229960001160 latanoprost Drugs 0.000 claims 1
- 230000007774 longterm Effects 0.000 claims 1
- 208000002780 macular degeneration Diseases 0.000 claims 1
- 208000029233 macular holes Diseases 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
- 230000000144 pharmacologic effect Effects 0.000 claims 1
- 230000035755 proliferation Effects 0.000 claims 1
- 230000000717 retained effect Effects 0.000 claims 1
- 208000004644 retinal vein occlusion Diseases 0.000 claims 1
- 208000037905 systemic hypertension Diseases 0.000 claims 1
- 229940124597 therapeutic agent Drugs 0.000 claims 1
- 231100000331 toxic Toxicity 0.000 claims 1
- 230000002588 toxic effect Effects 0.000 claims 1
- 231100000419 toxicity Toxicity 0.000 claims 1
- 230000001988 toxicity Effects 0.000 claims 1
- 230000001800 adrenalinergic effect Effects 0.000 abstract 1
- 229940113601 irrigation solution Drugs 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/407—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/08—Mydriatics or cycloplegics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/12—Ophthalmic agents for cataracts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
- A61P31/22—Antivirals for DNA viruses for herpes viruses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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.
Claims (14)
1. Use of a solution in the manufacture of a medicament for inhibiting a postoperative inflammatory condition following an ophthalmologic surgical procedure in a subject identified as having an elevated risk of suffering from a 5 postoperative inflammatory condition, wherein the solution includes ketorolac and phenylephrine in an intraocular irrigation carrier, wherein ketorolac and phenylephrine are included in the solution in amounts sufficient to maintain intraoperative pupil diameter by promoting mydriasis and inhibiting miosis during the ophthalmologic surgical procedure, 10 wherein the medicament is adapted for administration intraocularly to the subject during an ophthalmologic surgical procedure, and wherein the medicament is adapted to administer an amount sufficient for uptake of an amount of ketorolac in ocular tissues sufficient for inhibition of cyclooxygenases for a period of at least six hours postoperatively, thereby inhibiting 15 the postoperative inflammatory condition.
2. The use of Claim 1, wherein the solution comprises phenylephrine at a concentration of from 240 to 720 µM and the ketorolac is present at a concentration of from 44 to 134 µM.
3. The use of Claim 1, wherein the solution results in at least 90% inhibition 20 of baseline cyclooxygenase-1 and cyclooxygenase-2 activity levels in ocular tissues for a period of at least six hours postoperatively.
4. The use of Claim 1, wherein the solution results in at least 90% inhibition of baseline cyclooxygenase-1 and cyclooxygenase-2 activity levels in ocular tissues for a period of at least eight hours postoperatively. 25 5. The use of Claim 1, wherein the postoperative inflammatory condition is selected from the group consisting of toxic anterior-segment syndrome, cystoid macular edema, acute endophthalmitis, posterior capsule opacification, anterior capsule contraction, herpes simplex virus keratitis after cataract surgery, postsurgical hypotony, nylon suture toxicity, long-term corneal endothelial cell loss after cataract surgery, corneal edema, iris chafing, corneo-retinal inflammatory syndrome, scleritis, episcleritis, vitreous wick syndrome, post-operational acute iridocyclitis, uveitis,
5 epiretinal deposits after cataract extraction, reiterative membranous proliferation with giant-cell deposits, toxic vitreitis, posterior synechia, postoperative intraocular fibrin formation, incisional fibrosis, complications of macular hole surgery, choroidal effusion, and hypopyon.
6. The use of Claim 1, wherein the subject is at elevated risk of a 10 postoperative inflammatory condition because of a preoperative physiologic condition or characteristic, a preoperative treatment history, surgical trauma, or the surgical placement of a device that is associated with an enhanced incidence of postoperative inflammation.
7. The use of Claim 6, wherein the subject is at elevated risk of a 15 postoperative inflammatory condition because of a preoperative physiologic condition or characteristic including a preoperative dilated pupil diameter of less than 6 mm, floppy iris syndrome, uveitis, retinal vein occlusion, epiretinal membrane, being over 65 years of age, diabetes mellitus, diabetic macular edema, diabetic retinopathy, macular degeneration, or systemic hypertension; a preoperative 20 treatment history including previous ocular surgery or pharmacologic treatment with an alpha-1 adrenergic receptor antagonist or latanoprost; surgical trauma including posterior capsule rupture, secondary capsulotomy, iris incarceration, retained lens material, or vitreous loss; and the surgical placement of nylon sutures, iris-fixated intraocular lens or an anterior chamber intraocular lens. 25
8. Use of a solution in the manufacture of a medicament for reducing the incidence or severity of cystoid macular edema following an ophthalmologic surgical procedure in a subject identified as having an elevated risk of suffering from cystoid macular edema, wherein the solution includes ketorolac and phenylephrine in an intraocular irrigation carrier, wherein ketorolac and phenylephrine are included in the solution in amounts sufficient to maintain intraoperative pupil diameter by promoting mydriasis and inhibiting miosis during the ophthalmologic surgical procedure, 5 wherein the medicament is adapted for administration intraocularly to the subject during an ophthalmologic surgical procedure, and wherein the medicament is adapted to administer an amount sufficient for uptake of an amount of ketorolac in ocular tissues sufficient for inhibition of cyclooxygenases for a period of at least six hours postoperatively, thereby reducing 10 the incidence or severity of cystoid macular edema.
9. The use of Claim 8, wherein the solution comprises phenylephrine at a concentration of from 240 to 720 µM and the ketorolac is present at a concentration of from 44 to 134 µM.
10. The use of Claim 8, wherein a sufficient amount of the NSAID and the 15 mydriatic agent are included in the solution to maintain an intraoperative pupil diameter of at least 6.0 mm during the procedure.
11. The use of Claim 8, wherein the medicament is adapted for administration by continuous intracameral irrigation during the procedure.
12. The use of Claim 8, wherein the medicament is adapted for administration 20 by continuous intracameral irrigation during the procedure followed by injection of a bolus of the solution at the end of the procedure.
13. The use of Claim 8, wherein the medicament is adapted for administration by intracameral injection during a procedure in which another therapeutic agent is injected intraocularly. 25
14. The use of claim 1, substantially as herein described with reference to any one of the Examples and/or
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462086133P | 2014-12-01 | 2014-12-01 | |
| PCT/US2015/062929 WO2016089739A2 (en) | 2014-12-01 | 2015-11-30 | Anti-inflammatory and mydriatic intracameral solutions for inhibition of postoperative ocular inflammatory conditions |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| NZ732418A NZ732418A (en) | 2023-11-24 |
| NZ732418B2 true NZ732418B2 (en) | 2024-02-27 |
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