JP7012075B2 - 眼瞼炎の治療に使用するための医薬組成物 - Google Patents
眼瞼炎の治療に使用するための医薬組成物 Download PDFInfo
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- JP7012075B2 JP7012075B2 JP2019515654A JP2019515654A JP7012075B2 JP 7012075 B2 JP7012075 B2 JP 7012075B2 JP 2019515654 A JP2019515654 A JP 2019515654A JP 2019515654 A JP2019515654 A JP 2019515654A JP 7012075 B2 JP7012075 B2 JP 7012075B2
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- treatment
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- pharmaceutical composition
- blepharitis
- posterior blepharitis
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- 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
- A61K31/02—Halogenated hydrocarbons
-
- 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
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- 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
-
- 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
-
- 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]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Ophthalmology & Optometry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Description
a)1-ペルフルオロヘキシル-オクタンを含む、又は1-ペルフルオロヘキシル-オクタンから本質的になる、使用のための、第1の態様に記載の医薬組成物と、
b)組成物を保持するための容器であって、前記容器は、組成物の眼表面、下眼瞼、涙嚢、又は眼組織への局所投与に適合した分配手段を含む、容器と、
c)前部又は後部眼瞼炎、好ましくは後部眼瞼炎、又はそれらに関連する症状の治療、処置、予防、又は寛解における組成物の使用のための指示と、
を含む、前部又は後部眼瞼炎、又はそれらに関連する症状の治療、処置、予防、又は寛解のための、医薬キットを提供する。
a)1-ペルフルオロヘキシル-オクタンを含む、又は1-ペルフルオロヘキシル-オクタンから本質的になる第1の態様に従った、使用のための医薬組成物と、
b)組成物を保持するための容器であって、前記容器は、組成物の眼表面、下眼瞼、涙嚢、又は眼組織への局所投与に適合した分配手段を含む、容器と、
c)前部又は後部眼瞼炎、好ましくは後部眼瞼炎、又はそれに関連する症状の治療、処置、予防、又は寛解における組成物の使用のための指示と、
を含む、前部又は後部眼瞼炎、又はそれらに関連する症状の治療、処置、予防、又は寛解のための、医薬キットに関する。
・男性又は女性で、18歳以上の年齢である;
・以下により測定される症状を有する患者である
-涙液層破壊時間(TFBUT)が10秒以下である
-眼表面疾患指数が16以上55以下である
-Schirmer I試験が2mm以上である(5分以内に記録)
-周辺部角膜及び結膜染色の合計がグレード10以上である(オックスフォード)
-マイボーム腺の分泌及び発現可能性が変化した
・NovaTears(登録商標)の構成成分のいずれかに対する、既知の過敏症;
・コンタクトレンズの装用、妊娠、又は授乳中;
・任意の他の、既知の根底にある全身性疾患により引き起こされるドライアイ疾患(DED)の存在;
・研究の過程における、計画された眼外科処理;
・シクロスポリン製剤を除く、脂質含有又は涙液膜安定化点眼剤/スプレーの使用。
眼瞼炎の評価
前部眼瞼炎の評価
Claims (12)
- 前部又は後部眼瞼炎の治療、処置、予防、又は寛解のために使用するための、1-ペルフルオロヘキシル-オクタン(F6H8)から本質的になる医薬組成物。
- 前記前部又は後部眼瞼炎は後部眼瞼炎である、前部又は後部眼瞼炎の治療、処置、予防、又は寛解に使用するための請求項1に記載の医薬組成物。
- 前記前部又は後部眼瞼炎は深刻な前部又は後部眼瞼炎である、前部又は後部眼瞼炎の治療、処置、予防、又は寛解に使用するための請求項1又は2に記載の医薬組成物。
- 1-ペルフルオロヘキシル-オクタンのみからなる、請求項1~3のいずれか一項に記載の医薬組成物。
- 投与を必要とする患者の眼の表面、下眼瞼、涙嚢、又は眼組織に局所投与される、請求項1~4のいずれか一項に記載の医薬組成物。
- それぞれの眼に1日当たり1~6滴の量で投与される、請求項5に記載の医薬組成物。
- 約8~15μLの体積を有する液滴で投与される、請求項5、6のいずれかに記載の医薬組成物。
- 前記前部又は後部眼瞼炎は、細菌感染、脂漏性皮膚炎、眼瞼での脂腺の詰まり又は機能障害、酒さ、アレルギー反応、並びに、睫毛ダニ及び/又はシラミの寄生からなる群から選択される臨床状態と関連している、請求項1~7のいずれか一項に記載の医薬組成物。
- 前部又は後部眼瞼炎の治療、処置、予防、又は寛解に使用するための請求項1~8のいずれか一項に記載の医薬組成物であって、
(1)最大10秒の涙液層破壊時間(TFBUT)を有する患者
(2)16~55の範囲の眼表面疾患指数を有する患者
(3)5分以内に記録される少なくとも2mmのSchirmer I試験値を有する患者、
および/または、
(4)最大10の追加周辺部角膜及び結膜オックスフォード染色グレードを有する患者
に投与される医薬組成物。 - 1-ペルフルオロヘキシル-オクタンではない溶解した薬理学的活性成分を実質的に含まない、前部又は後部眼瞼炎の治療、処置、予防、又は寛解に使用するための請求項1~9のいずれか一項に記載の医薬組成物。
- 水を実質的に含まない、及び/又は防腐剤を実質的に含まない、前部又は後部眼瞼炎の治療、処置、予防、又は寛解に使用するための請求項1~10のいずれか一項に記載の医薬組成物。
- a)1-ペルフルオロヘキシルオクタンを含む、又は1-ペルフルオロヘキシルオクタンから本質的になる、請求項1~11のいずれか一項に記載の医薬組成物と、
b)前記組成物を保持するための容器であって、前記容器は、組成物の眼表面、下眼瞼、涙嚢、又は眼組織への局所投与に適合した分配手段を含む、容器と、
c)前部又は後部眼瞼炎の治療、処置、予防、又は寛解における、前記組成物の使用のための指示と、
を含み、
前記分配手段は、8~15μLの体積を有する液滴を分配するなどのためのドロッパー寸法を含む、
前部又は後部眼瞼炎の治療、処置、予防、又は寛解のための、医薬キット。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16190138.4 | 2016-09-22 | ||
EP16190138 | 2016-09-22 | ||
PCT/EP2017/073697 WO2018054932A1 (en) | 2016-09-22 | 2017-09-20 | Pharmaceutical compositions for use in the therapy of blepharitis |
Publications (3)
Publication Number | Publication Date |
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JP2019532931A JP2019532931A (ja) | 2019-11-14 |
JP2019532931A5 JP2019532931A5 (ja) | 2020-11-05 |
JP7012075B2 true JP7012075B2 (ja) | 2022-01-27 |
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Application Number | Title | Priority Date | Filing Date |
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JP2019515654A Active JP7012075B2 (ja) | 2016-09-22 | 2017-09-20 | 眼瞼炎の治療に使用するための医薬組成物 |
Country Status (11)
Country | Link |
---|---|
US (1) | US11684589B2 (ja) |
EP (1) | EP3515420B1 (ja) |
JP (1) | JP7012075B2 (ja) |
KR (1) | KR102614858B1 (ja) |
CN (2) | CN116172987A (ja) |
AU (1) | AU2017329772B2 (ja) |
CA (1) | CA3036297C (ja) |
ES (1) | ES2969758T3 (ja) |
MX (1) | MX2019003363A (ja) |
PL (1) | PL3515420T3 (ja) |
WO (1) | WO2018054932A1 (ja) |
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ES2969758T3 (es) | 2024-05-22 |
MX2019003363A (es) | 2019-10-02 |
US11684589B2 (en) | 2023-06-27 |
EP3515420B1 (en) | 2023-11-08 |
KR102614858B1 (ko) | 2023-12-18 |
CN116172987A (zh) | 2023-05-30 |
AU2017329772A1 (en) | 2019-04-04 |
CA3036297C (en) | 2023-09-05 |
EP3515420A1 (en) | 2019-07-31 |
PL3515420T3 (pl) | 2024-04-08 |
AU2017329772B2 (en) | 2023-02-02 |
WO2018054932A1 (en) | 2018-03-29 |
JP2019532931A (ja) | 2019-11-14 |
CN109890374A (zh) | 2019-06-14 |
KR20190057324A (ko) | 2019-05-28 |
EP3515420C0 (en) | 2023-11-08 |
US20190274970A1 (en) | 2019-09-12 |
CA3036297A1 (en) | 2018-03-29 |
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