Generic Name and Formulations:
Aflibercept 40mg/mL; soln for oph intravitreal inj; preservative-free.

11月18日，美国食品与药物管理局（FDA）批准Eylea(阿柏西普，aflibercept) 治疗有新生血管的年龄相关性黄斑变性（AMD），该病是美国60岁以上人群视力丧失和致盲的首要原因。
两项纳入2412例成年患者的临床试验评价了Eylea的安全性和有效性。参试者接受Eylea或Lucentis（雷珠单抗注射）治疗。两研究的主要终点是治疗一年后病人视力的视敏度。
每4周或每8周，Eylea由眼科医师注入病人眼内。研究显示，在维持或改善视敏度方面，Eylea与Lucentis同样有效。
接受Eylea病人最常见的副作用包括眼痛、结膜出血、玻璃体漂浮物、白内障和眼压增高。
FDA告诫，Eylea不应用于有活动性眼部感染或有眼内活动性炎症的病人。Eylea尚未在妊娠妇女中进行研究，所以，只有当治疗的潜在益处超过潜在风险时才能用于妊娠妇女。年龄相关的黄斑变性不出现在儿童，Eylea未在儿童中进行研究。
Company:
Regeneron
Indications for EYLEA:
Neovascular (wet) age-related macular degeneration (AMD). Macular edema following central retinal vein occlusion (CRVO).

Adult Dose for EYLEA:
Give by intravitreal inj. AMD: 2mg (0.05mL) once every 4 weeks (monthly) for the 1st 3 months, followed by 2mg (0.05mL) once every 8 weeks. CRVO: 2mg once every 4 weeks (monthly).

Children's Dose for EYLEA:
Not established.

Pharmacological Class:
Recombinant fusion protein (human VEGF inhibitor + human IgG1).

Contraindications:
Ocular or periocular infections. Active intraocular inflammation.

Warnings/Precautions:
Potential risk of arterial thromboembolic events (eg, nonfatal stroke or MI, vascular death). Monitor for endophthalmitis and retinal detachments during the week following injection. Monitor intraocular pressure and perfusion of optic nerve head after injection. Pregnancy (Cat.C). Nursing mothers: not recommended.

Adverse Reactions:
Conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, increased intraocular pressure, conjunctival hyperemia, corneal erosion, inj site pain, foreign body sensation in eye.

Generic Availability:
NO

How Supplied:
Vial (for single eye use)—1 (w. needles + syringe)