Allergan公司近日表示美国FDA批准了公司的可注射眼植入剂Ozurdex 用于治疗黄斑水肿，该药注入眼中后将释放高浓度的地塞米松。Ozurdex注入眼中后是可降解的，临床试验中有约1300名受试者参加。
公司说道，该药在医生办公室就可以注射给药，将在今年晚些时间在美国上市
Indication: OZURDEX™ (dexamethasone intravitreal implant) 0.7 mg is indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Dosage and Administration: For ophthalmic intravitreal injection only.
The intravitreal injection procedure should be carried out under controlled aseptic conditions. Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.
Important Safety Information
Contraindications: OZURDEX™ is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases. It is also contraindicated in patients with advanced glaucoma and in patients with known hypersensitivity to any components of this product or to other corticosteroids.
Warnings and Precautions: Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the injection. Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex. Corticosteroids should not be used in active ocular herpes simplex.
Adverse reactions: The most common ocular adverse reactions reported by greater than 2% of the patients in the first 6 months included increased intraocular pressure (25%), conjunctival hemorrhage (20%), eye pain (7%), conjunctival hyperemia (7%), ocular hypertension (4%), cataract (4%), vitreous detachment (3%), and headache (3%).
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