AMD诊断和疗新进展.pptVIP

Manufacturing standards for ophthalmic injections are much more stringent with regards to sterility and particulate matter. Bevacizumab was developed for applications in oncology and has not been registered for any application in ophthalmology in any country. Ranibizumab was developed specifically for ocular use. Therefore, ranibizumab (but not bevacizumab) is manufactured according to US Pharmacopoeia specifications for injections into the eye. In intravenous medications (such as bevacizumab) more particulate matter is tolerated, but this may cause irritation and inflammation if injected into the eye. United States Pharmacopoeia specifications for pharmaceutical liquid formulations allow up to 3000 particles of ≥10 μm in a volume of 1 mL (as measured using a membrane microscopic assay). For the same volume of an ophthalmic product, using the same assay, a maximum of just 50 particles of ≥10 μm is permitted.1,2 USP 28/NF 23, Chapter 788 Particulate Matter in Injections. United States Pharmacopeial Convention, Inc. Rockville, MD 2005. USP 28/NF 23, Chapter 789 Particulate Matter in Ophthalmic Solutions. United States Pharmacopeial Convention, Inc. Rockville, MD 2005. 改 * * Ferrara N et al. The biology of VEGF and its receptors. Nat Med. 2003;9:669-676. * * * * 酪氨酸激酶抑制剂 Vatalanib (PTK787 ) – 口服给药 Novartis 优良的口服生物利用度和活性， 抑制VEGF受体家族, PDGF受体及c-Kit受体 已完成Phase I/II 试验(ADVANCE) 目前暂无进一步研究计划 Pazopanib 滴眼液 GlaxoSmithKline (GSK) 具有潜在抗肿瘤作用的小分子酪氨酸激酶抑制剂 选择性抑制VEGF 受体-1, -2 and -3, c-kit 及 PDGF受体 正在进行Phase IIb试验 雷珠单抗尚未在中国批准上市 Small Interfering RNA (siRNA) DNA --- mRNA --- Protein 干扰VEGF合成- Bevasiranib (Opko) - 已终止研究 干扰VEGF受体1合成 - SIRNA-027 (Sirna/Allergan) – 已完成PhaseI/II试验 雷珠单抗尚未在中国批准上市 PDGF 抑制剂 - anti-PDGF适配体 - E10030 (Ophthotech) 整合素拮抗剂 - JSM6427（Jerini）- 已完成Phase I试验 补体抑制剂 - C5 ARC1905(Ophthotech) – PhaseI试验进行中 Eculizumab(SOLIRIS, Alexion) Phase II试验进行中 - C3 POT-4(Potentia) – 已完成PhaseI试验 免疫抑制剂