JP6132964B2 - 萎縮性加齢性黄斑変性の処置方法 - Google Patents
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Description
下記の用語は、下記の意味を有することが定義される:
下記の実施例は本発明の様々な局面および実施形態を例示する。
78歳の男性が加齢性黄斑変性および白内障を両方の眼に有する。この患者はまた、心臓血管疾患および下壁心筋梗塞の病歴を6ヶ月前に有し得る。この患者は、右眼におけるかすんだ視覚および変視症を訴えることがあり、検査により、右眼の視力が20/400であり、左眼の視力が20/32であることが明らかにされ得る。網膜検査では、右眼において、サイズがおよそ1つ分の円板区域である中心窩下脈絡膜血管新生(CNV)(右眼のwet型AMD)が、周囲の出血および浮腫とともに示され得る。左眼では、脈絡膜血管新生の徴候は、フルオレセイン血管造影法によって確認されないが、wet型AMDを発症することについての高リスクの特徴(例えば、中心窩を含んだ軟らかい無定形態らしいドルーゼン)が示され得る(左眼のdry型AMD)。患者は、wet型AMDの右眼においてラニビズマブ(抗血管新生剤)の月1回の硝子体内注入を開始することができ、4ヶ月以内に浮腫および出血が消散し、視力が20/125に回復する。
74歳の男性が、片方(右)の眼がdry型加齢性AMDであり、他方(左)の眼がwet型AMDであると診断されている。この男性は、右眼の視力が20/40である。この男性は、dry型AMD眼の中への持続放出型薬物送達システムの硝子体内注入によって処置される。持続放出型薬物送達システムは、総量で約6マイクログラム(低用量)の活性薬剤(ベバシズマブ)をポリマービヒクルに含む。ポリマービヒクルは、高粘度ヒアルロン酸またはPLGAもしくはPLAであり、ベバシズマブ(抗血管新生剤)とともに、複数のミクロスフェアまたは1つのモノリシックインプラント(その中で、ベバシズマブは均一に分布する)を形成する。あるいは、持続放出型薬物送達システムは、ベバシズマブのミクロスフェアまたはインプラントをヒアルロン酸(架橋型または非架橋型)中に含むことができ、その結果、粘性のポリマービヒクル(ヒアルロン酸)および固体のポリマービヒクル(PLAまたはPLGAのミクロスフェアまたはインプラント)の両方が同じ薬物送達システムに存在する。薬物送達システムは6μgのベバシズマブを1〜6ヶ月の期間にわたって硝子体の中に放出することができ、その後で、患者の右眼は血管新生の証拠を全く示すことがなく、かつ、右眼において維持された同じ視力(20/40)を示すことができる。
83歳の女性が、左眼においてかすんだ視覚で起床することがある。この女性は、緑内障、白内障除去後IOL(眼内レンズ)を挿入した状態、および、dry型AMDの病歴を両眼に有し得、Alphagan P点眼薬を使用し続け得る。この女性の眼科医の検査により、この女性は、左眼がwet型AMDであると診断され、直ちに網膜専門医に紹介され得る。視力は右眼が20/25であり、左眼が20/200であり得る。網膜検査では、右眼黄斑におけるdry型変化(ただし、中心窩下領域における大きいドルーゼンおよび多数の色素性変化のような高リスクの特徴がある)が示され得る。左眼の黄斑は、サイズがおよそ2つ分の円板区域の中心窩下CNVを、周囲の黄斑浮腫および網膜内出血とともに示し得る。フルオレセイン血管造影法では、主に外見が典型的である左眼CNVの存在が確認され得る。患者は、wet型AMDの左眼においてラニビズマブの月1回の硝子体内注入を直ちに開始することができる。網膜浮腫が3ヶ月の期間にわたって消失するが、患者の左眼視力は、20/100へとやや改善し得るに過ぎない。患者は、右眼においてCNVを発症する危険性が高かったので、また、左眼における視力が3ヶ月の期間にわたってあまり改善され得ないので、右眼におけるCNVの発症を予防するために、PLGAミクロスフェアに取り込まれた4.8mgのラニビズマブを含む50μlの硝子体内注入を右眼に受けることができる。インビトロ放出速度が5μg/日であるポリソルベート20PLGAミクロスフェアもまた、網膜透過性を高めるために配合物に入れることができる。ミクロスフェアを、部分的架橋のヒアルロン酸(HA)に2.1%のHA濃度で入れることができる。そのような架橋HAを、Allergan Medical(Irvine、California)から、Juvederm Ultra Plus、Juvederm 30、CaptiqueおよびVolumaの商品名で入手することができる。
網膜色素上皮(「RPE」)細胞に対するポリソルベート網膜浸透強化剤の毒性を調べるために実験を行った。すなわち、ARPE-19細胞(Dunn K.他、ARPE-19, a human retinal pigment epithelial cell line with differential properties、Exp Eye Res.、1996 Feb;62 (2):155-69を参照のこと)を、0%から0.10%(w/w)の範囲のポリソルベート80濃度でインビトロにおいてインキュベーションし、細胞生存性アッセイを行った。
(a)配合において一般に使用される濃度
(b)化合物溶解性に対する限界濃度
(c)適用可能な粘度、浸透圧およびpHの値に対する限界濃度。
%細胞生存=OD試験/ODコントロール×100。
3実験を同じ条件で独立して完了した後、グラフを3組の値からプロットし、これにより、実験間の標準偏差値を得た。このようにして、50%の細胞生存性をもたらす濃度を求めた。形態学的外観を、5から1(すなわち、正常から致死的表現型)の範囲での半定量的なスコア化によって解析した。
従って、特許請求の範囲の精神および範囲は、上記の好ましい実施形態の記載に限定されてはならない。
Claims (7)
- dry型加齢性黄斑変性(AMD)からwet型AMDへの進行を防止または遅延する方法において使用するための生体適合性の薬物送達システムであって、ベバシズマブのエステル、ラニビズマブのエステル、ならびにそれらの塩および混合物から選択される抗血管新生剤と、該抗血管新生剤を伴うポリマービヒクルとを含み;
ここで、
前記ポリマービヒクルは乳酸−グリコール酸コポリマーであり、
前記方法は、前記薬物送達システムを、患者のdry型AMDの眼に投与するステップを含み、該患者は他方の眼にwet型AMDを有し、
前記投与ステップは、dry型AMD眼の硝子体腔内への前記薬物送達システムの注入により実施される、
薬物送達システム。 - 抗血管新生剤が、ポリマービヒクル全体に均一に分散されることによってポリマービヒクルに伴う、請求項1に記載の薬物送達システム。
- 抗血管新生剤が、ベバシズマブのエステルまたはその塩である、請求項1に記載の薬物送達システム。
- 薬物送達システムが、5μg〜3mgのベバシズマブを含む、請求項3に記載の薬物送達システム。
- 薬物送達システムが、24時間にわたって平均して10ng〜40μgのベバシズマブを放出する、好ましくは24時間にわたって平均して14μg〜28μgまたは平均して7μg〜14μgのベバシズマブを放出する、請求項4に記載の薬物送達システム。
- 薬物送達システムが、25℃において0.1/秒の剪断速度で、130,000cps〜300,000cpsの間の粘度を有する、請求項1に記載の薬物送達システム。
- 前記方法が、薬物送達システムを25〜30ゲージのシリンジを使用して眼に注入することを含む、請求項1に記載の薬物送達システム。
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US12/176,238 US8821870B2 (en) | 2008-07-18 | 2008-07-18 | Method for treating atrophic age related macular degeneration |
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US20090148527A1 (en) * | 2007-12-07 | 2009-06-11 | Robinson Michael R | Intraocular formulation |
US20070202186A1 (en) | 2006-02-22 | 2007-08-30 | Iscience Interventional Corporation | Apparatus and formulations for suprachoroidal drug delivery |
US8197435B2 (en) | 2006-05-02 | 2012-06-12 | Emory University | Methods and devices for drug delivery to ocular tissue using microneedle |
US8039010B2 (en) | 2006-11-03 | 2011-10-18 | Allergan, Inc. | Sustained release intraocular drug delivery systems comprising a water soluble therapeutic agent and a release modifier |
US8821870B2 (en) * | 2008-07-18 | 2014-09-02 | Allergan, Inc. | Method for treating atrophic age related macular degeneration |
US8623395B2 (en) | 2010-01-29 | 2014-01-07 | Forsight Vision4, Inc. | Implantable therapeutic device |
EP2391419B1 (en) | 2009-01-29 | 2019-06-12 | ForSight Vision4, Inc. | Posterior segment drug delivery |
IN2012DN03361A (ja) * | 2009-10-01 | 2015-10-23 | Evonik Degussa Corp | |
WO2011087066A1 (ja) * | 2010-01-14 | 2011-07-21 | 株式会社三和化学研究所 | 眼内血管新生及び/又は眼内血管透過性亢進を伴う疾患の予防又は治療のための医薬 |
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