WO2022244765A1 - 近視抑制用点眼剤 - Google Patents
近視抑制用点眼剤 Download PDFInfo
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- WO2022244765A1 WO2022244765A1 PCT/JP2022/020514 JP2022020514W WO2022244765A1 WO 2022244765 A1 WO2022244765 A1 WO 2022244765A1 JP 2022020514 W JP2022020514 W JP 2022020514W WO 2022244765 A1 WO2022244765 A1 WO 2022244765A1
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- WIPO (PCT)
- Prior art keywords
- myopia
- eye
- suppressing
- bunazosin
- eye drop
- Prior art date
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- 208000001491 myopia Diseases 0.000 title claims abstract description 46
- 239000003889 eye drop Substances 0.000 title claims abstract description 41
- 230000004379 myopia Effects 0.000 title claims abstract description 37
- RHLJLALHBZGAFM-UHFFFAOYSA-N Bunazosinum Chemical compound C1CN(C(=O)CCC)CCCN1C1=NC(N)=C(C=C(OC)C(OC)=C2)C2=N1 RHLJLALHBZGAFM-UHFFFAOYSA-N 0.000 claims abstract description 23
- 229960002467 bunazosin Drugs 0.000 claims abstract description 23
- 229940012356 eye drops Drugs 0.000 claims description 21
- 239000000203 mixture Substances 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 238000000034 method Methods 0.000 claims description 2
- 230000001629 suppression Effects 0.000 claims description 2
- 239000000243 solution Substances 0.000 abstract 1
- 210000001508 eye Anatomy 0.000 description 22
- 230000004323 axial length Effects 0.000 description 17
- 230000000694 effects Effects 0.000 description 16
- 239000002997 ophthalmic solution Substances 0.000 description 9
- 208000010412 Glaucoma Diseases 0.000 description 8
- 229940054534 ophthalmic solution Drugs 0.000 description 8
- 229960004317 unoprostone Drugs 0.000 description 8
- TVHAZVBUYQMHBC-SNHXEXRGSA-N unoprostone Chemical compound CCCCCCCC(=O)CC[C@H]1[C@H](O)C[C@H](O)[C@@H]1C\C=C/CCCC(O)=O TVHAZVBUYQMHBC-SNHXEXRGSA-N 0.000 description 8
- 238000002474 experimental method Methods 0.000 description 7
- 239000006196 drop Substances 0.000 description 5
- 241000699670 Mus sp. Species 0.000 description 4
- 230000004329 axial myopia Effects 0.000 description 4
- 241000699666 Mus <mouse, genus> Species 0.000 description 3
- 239000000654 additive Substances 0.000 description 3
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 3
- XXUPXHKCPIKWLR-JHUOEJJVSA-N isopropyl unoprostone Chemical compound CCCCCCCC(=O)CC[C@H]1[C@H](O)C[C@H](O)[C@@H]1C\C=C/CCCC(=O)OC(C)C XXUPXHKCPIKWLR-JHUOEJJVSA-N 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 239000002953 phosphate buffered saline Substances 0.000 description 3
- 229950008081 unoprostone isopropyl Drugs 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 2
- 210000005252 bulbus oculi Anatomy 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- LSIXBBPOJBJQHN-UHFFFAOYSA-N 2,3-Dimethylbicyclo[2.2.1]hept-2-ene Chemical compound C1CC2C(C)=C(C)C1C2 LSIXBBPOJBJQHN-UHFFFAOYSA-N 0.000 description 1
- 101800004538 Bradykinin Proteins 0.000 description 1
- 241000725101 Clea Species 0.000 description 1
- PANKHBYNKQNAHN-JTBLXSOISA-N Crocetin Natural products OC(=O)C(\C)=C/C=C/C(/C)=C\C=C\C=C(\C)/C=C/C=C(/C)C(O)=O PANKHBYNKQNAHN-JTBLXSOISA-N 0.000 description 1
- QXZGBUJJYSLZLT-UHFFFAOYSA-N H-Arg-Pro-Pro-Gly-Phe-Ser-Pro-Phe-Arg-OH Natural products NC(N)=NCCCC(N)C(=O)N1CCCC1C(=O)N1C(C(=O)NCC(=O)NC(CC=2C=CC=CC=2)C(=O)NC(CO)C(=O)N2C(CCC2)C(=O)NC(CC=2C=CC=CC=2)C(=O)NC(CCCN=C(N)N)C(O)=O)CCC1 QXZGBUJJYSLZLT-UHFFFAOYSA-N 0.000 description 1
- 206010020675 Hypermetropia Diseases 0.000 description 1
- 102100035792 Kininogen-1 Human genes 0.000 description 1
- 208000022873 Ocular disease Diseases 0.000 description 1
- 230000002350 accommodative effect Effects 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 210000001742 aqueous humor Anatomy 0.000 description 1
- 210000001110 axial length eye Anatomy 0.000 description 1
- 239000003899 bactericide agent Substances 0.000 description 1
- IUGQFMIATSVYLK-UHFFFAOYSA-N benzyl 2-(4-hydroxyphenyl)acetate Chemical compound C1=CC(O)=CC=C1CC(=O)OCC1=CC=CC=C1 IUGQFMIATSVYLK-UHFFFAOYSA-N 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- QXZGBUJJYSLZLT-FDISYFBBSA-N bradykinin Chemical compound NC(=N)NCCC[C@H](N)C(=O)N1CCC[C@H]1C(=O)N1[C@H](C(=O)NCC(=O)N[C@@H](CC=2C=CC=CC=2)C(=O)N[C@@H](CO)C(=O)N2[C@@H](CCC2)C(=O)N[C@@H](CC=2C=CC=CC=2)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)CCC1 QXZGBUJJYSLZLT-FDISYFBBSA-N 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 229960003612 bunazosin hydrochloride Drugs 0.000 description 1
- PANKHBYNKQNAHN-JUMCEFIXSA-N carotenoid dicarboxylic acid Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C(=O)O)C=CC=C(/C)C(=O)O PANKHBYNKQNAHN-JUMCEFIXSA-N 0.000 description 1
- 239000002738 chelating agent Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 239000002826 coolant Substances 0.000 description 1
- PANKHBYNKQNAHN-MQQNZMFNSA-N crocetin Chemical compound OC(=O)C(/C)=C/C=C/C(/C)=C/C=C/C=C(\C)/C=C/C=C(\C)C(O)=O PANKHBYNKQNAHN-MQQNZMFNSA-N 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000036040 emmetropia Effects 0.000 description 1
- 230000029142 excretion Effects 0.000 description 1
- 230000004305 hyperopia Effects 0.000 description 1
- 201000006318 hyperopia Diseases 0.000 description 1
- 230000006698 induction Effects 0.000 description 1
- 230000004410 intraocular pressure Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000002075 main ingredient Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000010172 mouse model Methods 0.000 description 1
- 238000012014 optical coherence tomography Methods 0.000 description 1
- -1 pH adjusters Substances 0.000 description 1
- 239000002304 perfume Substances 0.000 description 1
- 239000002831 pharmacologic agent Substances 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000004515 progressive myopia Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 230000004436 pseudomyopia Effects 0.000 description 1
- 230000004331 refractive myopia Effects 0.000 description 1
- 239000003590 rho kinase inhibitor Substances 0.000 description 1
- 230000003595 spectral effect Effects 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 230000004304 visual acuity Effects 0.000 description 1
Images
Classifications
-
- 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
- A61P27/10—Ophthalmic agents for accommodation disorders, e.g. myopia
-
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
-
- 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
Definitions
- the present invention relates to eye drops for suppressing myopia.
- Myopia is especially common among Asians, especially Japanese, and the percentage of strong myopia of -5D or higher is also high.
- myopia has been increasing all over the world, and the percentage of children with unaided visual acuity of less than 1.0 is increasing year by year in Japan. It is also known that myopia progresses rapidly during the childhood period from 7 to 12 years old (see Non-Patent Document 1).
- Myopia is classified into refractive myopia, accommodative myopia (pseudomyopia), and axial myopia according to its onset mechanism, but myopia progression in school children is mainly axial myopia.
- the human eye is hyperopic immediately after birth, and the extent of hyperopia decreases due to eye axis extension during growth, and becomes emmetropia when children enter school. Axial elongation after this emmetropic phenomenon directly leads to myopia, and the axial length once elongated cannot be restored. Therefore, it is believed that suppression of axial extension during the period from growth to school age is effective for preventing or treating myopia (see Non-Patent Document 2).
- the ocular axis extends not only in the growth period but also in adults, and it is said that the elongation of the ocular axis in adults is a risk factor for various ocular diseases.
- a therapeutic agent for preventing myopia has been proposed, for example, a Rho kinase inhibitor (see Patent Document 1), bradykinin (Patent Document 2), crocetin (Patent Document 3), etc. have been proposed.
- An object of the present invention is to provide a new eye drop for suppressing myopia.
- the ophthalmic solution for suppressing myopia according to the present invention is characterized by containing bunazosin.
- the eye drops for suppressing myopia according to the present invention will be explained.
- the present invention is not limited to the following embodiments and examples, and includes various modifications and applications within the scope of the present invention.
- Eye drops for suppressing myopia The present inventors focused on the fact that some eye drops for glaucoma are effective in suppressing the progress of myopia, and attempted to find out the effect of suppressing the progress of myopia from existing eye drops for glaucoma.
- glaucoma eye drops were instilled into a mouse model of myopia, the axial length and refractive index were measured, and whether or not there was an effect of suppressing progression of axial myopia was evaluated.
- an eye drop containing bunazosin is effective as an eye drop for suppressing myopia.
- the type of ophthalmic solution containing bunazosin is not particularly limited, it is preferably an aqueous ophthalmic solution.
- other active ingredients pharmaceutically active ingredients, physiologically active ingredients, other glaucoma eye drop ingredients, etc.
- the eye drops may contain one or more of them by appropriately selecting various ingredients and additives in accordance with conventional methods, depending on the application and form, within the range that does not impair the effects of the present invention. can be done.
- these components or additives include various additives such as perfumes or cooling agents, preservatives, bactericides or antibacterial agents, pH adjusters, chelating agents, stabilizers, tonicity agents, and buffers. can be mentioned.
- the content of bunazosin is set to a realistic amount. It is preferable to use it, and it can be blended within a range that does not impair the effects of the present invention.
- the usage and dosage of the eye drops vary depending on the patient's symptoms, age, etc., but usually about 1 to 6 times a day, about 1 to 2 drops per time.
- the present invention uses bunazosin-containing eye drops as myopia-suppressing eye drops.
- the present invention can be expressed as ii) use of a composition containing bunazosin for the manufacture of an eye drop for myopia reduction, and (ii) a method for reducing myopia by instilling a composition containing bunazosin as an eye drop.
- the "myopia suppressing effect" referred to in the present application is an effect of suppressing progression of axial myopia.
- mice C57BL6/J, CLEA Japan, Inc.
- D is an abbreviation for Diopter, which is the unit of refractive power of the lens
- Eyes were fitted with 30D lenses to induce myopia.
- Instillation was continued for 3 weeks, with PBS (Phosphate Buffered Saline) instillation as a control group and bunazosin instillation as a test group.
- PBS Phosphate Buffered Saline
- Bunazosin is the main component of detantol ophthalmic solution, and bunazosin was applied using detantol 0.01% ophthalmic solution (manufactured by Santen Pharmaceutical Co., Ltd., 1 mL of which contains 0.1 mg of bunazosin hydrochloride).
- the frequency of instillation was 2 drops once a day and 2 drops a day (2 drops each in the morning and evening). After 3 weeks, the refractive index and axial length of the mouse eyeball were measured, and the amount of change was calculated.
- * indicates that p ⁇ 0.05
- ** indicates that p ⁇ 0.01 (same in the figures of the present application).
- Refractive values were measured using an infrared photoreflector for mice (Infrared photorefractor for mice, manufactured by Professor Schaeffel, University of Tubingen). Spectral domain optical coherence tomography (Envisu R4310, manufactured by Leica) was used to measure the axial length.
- FIG. 2 shows the refractive index results. The more negative the refractive index, the more myopic.
- the eye with the ⁇ 30D lens became myopic, which was significantly different from the eye with the 0D lens.
- the eye drop group there was no significant difference between the eye with the ⁇ 30D lens and the eye with the 0D lens, and it was found to be effective in suppressing myopia. It should be noted that the effect of suppressing myopia was observed with the one-time instillation rather than the two-time instillation.
- Figure 3 shows the results of the axial length of the eye. The greater the axial length value, the more myopic.
- the axial length of the eye with the -30D lens was elongated, and there was a significant difference with the eye with the 0D lens.
- the instillation group there was almost no difference in axial length between the two eyes, and a myopia-suppressing effect was observed. No difference was observed between the one-time instillation and the two-time instillation.
- Example 2 Mice similar to Experiment 1 were used and myopia was induced. Eye instillation was continued for 3 weeks, PBS eye instillation was used as a control group, and unoprostone eye instillation was used as a test group. Unoprostone is the main component of Rescula ophthalmic solution. Unoprostone eye drop is Rescula ophthalmic solution 0.12% (Nitto Medic Co., Ltd., 1 mL contains 1.2 mg of isopropyl unoprostone) eye drops (both eyes, once a day). 2 drops each time). After 3 weeks, the refractive index and axial length of the mouse eyeball were measured, and the amount of change was calculated. Refractive index measurement and axial length measurement are the same as in Experiment 1.
- FIG. 4 shows the refractive index results.
- the eye with the ⁇ 30D lens became myopic, which was significantly different from the eye with the 0D lens.
- both eyes became myopic, and no myopia-suppressing effect was observed with instillation.
- Fig. 5 shows the results of eye axial length.
- the axial length of the eye with the -30D lens was elongated, and there was a significant difference with the eye with the 0D lens.
- no significant difference was observed in the axial length of both eyes in the instillation group.
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- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract
Description
本発明者らは、緑内障の点眼薬には近視進行抑制に効果的であるものがあることに着目し、既存の緑内障点眼薬から近視進行抑制効果を見つける試みを行った。本願では、緑内障点眼薬をマウス近視モデルに点眼し、眼軸長と屈折率を測定し、軸性近視の進行抑制効果があるか否かを評価した。
図1に示すように、生後3週齢のマウス(C57BL6/J,日本クレア株式会社)に、左眼0D(「D」はDiopterの略で、レンズの屈折力の単位である。)及び右眼-30Dのレンズを装着し、近視を誘導した。点眼は3週間継続し、PBS(Phosphate Buffered Saline)点眼を対照群とし、ブナゾシン点眼を試験群とした。ブナゾシンはデタントール点眼液の主成分であり、ブナゾシンの点眼はデタントール0.01%点眼液(参天製薬株式会社製、1mL中にブナゾシン塩酸塩が0.1mg含まれる)を用いて行った。点眼回数については、1日1回2滴の場合と1日2回(朝、夕各2滴)の場合とした。3週間後のマウス眼球の屈折率及び眼軸長を測定し、その変化量を計算した。なお、図中、*はp<0.05、**はp<0.01であることを示す(本願の図において同じ。)。
屈折値の測定は、マウス用赤外線フォトリフレクター(Infrared photorefractor for mice、Tubingen大学Schaeffel教授作製)を用いた。眼軸長の測定は、スペクトラルドメイン光コヒーレンストモグラフィー(Envisu R4310、Leica社製)を用いた。
図2は屈折率の結果である。屈折率は負数になるほど近視になる。対照群の屈折率の変化では、-30Dレンズの眼は近視となり、0Dの眼と有為差がみられた。一方、点眼群では、-30Dレンズの眼と0Dの眼との有為差はなく、近視抑制に効果があることがわかった。なお、1回点眼の方が2回点眼より近視抑制効果が見られた。
実験1と同様のマウスを使用し、近視を誘導した。点眼は3週間継続し、PBS点眼を対照群とし、ウノプロストン点眼を試験群とした。ウノプロストンはレスキュラ点眼液の主成分であり、ウノプロストンの点眼はレスキュラ点眼液0.12%(日東メディック株式会社、1mL中にイソプロピルウノプロストンが1.2mg含まれる)の点眼(両目、1日1回2滴)で行った。3週間後のマウス眼球の屈折率及び眼軸長を測定し、その変化量を計算した。屈折率測定と眼軸長測定は実験1と同じである。
図4は屈折率の結果である。対照群の屈折率の変化では、-30Dレンズの眼は近視となり、0Dの眼と有為差がみられた。一方、点眼群では、両目が近視となり、点眼での近視抑制効果は見られなかった。
Claims (4)
- ブナゾシンを含む点眼剤である、ことを特徴とする近視抑制用点眼剤。
- ブナゾシンを含む組成物の近視抑制用点眼剤としての使用。
- 近視抑制のための点眼剤の製造のための、ブナゾシンを含む組成物の使用。
- ブナゾシンを含む組成物を点眼剤として点眼する近視抑制方法。
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2022276728A AU2022276728A1 (en) | 2021-05-17 | 2022-05-17 | Eye drop for suppressing myopia |
EP22804676.9A EP4342472A1 (en) | 2021-05-17 | 2022-05-17 | Eye drop for suppressing myopia |
CN202280035569.4A CN117320726A (zh) | 2021-05-17 | 2022-05-17 | 抑制近视用滴眼剂 |
CA3216748A CA3216748A1 (en) | 2021-05-17 | 2022-05-17 | Ophthalmic preparation for myopia supression |
KR1020237038535A KR20240008848A (ko) | 2021-05-17 | 2022-05-17 | 근시억제용 점안제 |
Applications Claiming Priority (2)
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JP2021082858A JP6917103B1 (ja) | 2021-05-17 | 2021-05-17 | 近視抑制用点眼剤 |
JP2021-082858 | 2021-05-17 |
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WO2022244765A1 true WO2022244765A1 (ja) | 2022-11-24 |
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EP (1) | EP4342472A1 (ja) |
JP (1) | JP6917103B1 (ja) |
KR (1) | KR20240008848A (ja) |
CN (1) | CN117320726A (ja) |
AU (1) | AU2022276728A1 (ja) |
CA (1) | CA3216748A1 (ja) |
TW (1) | TW202313058A (ja) |
WO (1) | WO2022244765A1 (ja) |
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Citations (7)
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JPS63301822A (ja) * | 1987-06-01 | 1988-12-08 | Eisai Co Ltd | 角膜透過促進点眼剤 |
JP2003292442A (ja) * | 2002-01-29 | 2003-10-15 | Santen Pharmaceut Co Ltd | ブナゾシンとプロスタグランジン類からなる緑内障治療剤 |
WO2006137368A1 (ja) * | 2005-06-21 | 2006-12-28 | Kowa Co., Ltd. | 緑内障の予防又は治療剤 |
WO2010010702A1 (ja) | 2008-07-24 | 2010-01-28 | 国立大学法人大阪大学 | 軸性近視の予防または治療剤 |
JP2011144111A (ja) | 2010-01-12 | 2011-07-28 | Osaka Univ | 軸性近視の予防または治療剤 |
JP2016132616A (ja) * | 2015-01-15 | 2016-07-25 | 大内新興化学工業株式会社 | 眼疾患治療用ナノ粒子製剤 |
WO2018212152A1 (ja) | 2017-05-15 | 2018-11-22 | 株式会社坪田ラボ | 近視予防用組成物及び機能性食品 |
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2021
- 2021-05-17 JP JP2021082858A patent/JP6917103B1/ja active Active
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2022
- 2022-05-17 KR KR1020237038535A patent/KR20240008848A/ko unknown
- 2022-05-17 CN CN202280035569.4A patent/CN117320726A/zh active Pending
- 2022-05-17 AU AU2022276728A patent/AU2022276728A1/en active Pending
- 2022-05-17 WO PCT/JP2022/020514 patent/WO2022244765A1/ja active Application Filing
- 2022-05-17 TW TW111118406A patent/TW202313058A/zh unknown
- 2022-05-17 CA CA3216748A patent/CA3216748A1/en active Pending
- 2022-05-17 EP EP22804676.9A patent/EP4342472A1/en active Pending
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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CN117320726A (zh) | 2023-12-29 |
JP6917103B1 (ja) | 2021-08-11 |
KR20240008848A (ko) | 2024-01-19 |
TW202313058A (zh) | 2023-04-01 |
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