Ozurdex steroid implants

On February 1, 2017, the company acquired LifeCell, a specialist in regenerative medicine, for $ billion. [32] On April 28, the company acquired Zeltiq Aesthetics , marketer of a cryolipolysis procedure, for $ billion. [33] On June 7, the company announced the acquisition of Keller Medical, a company that manufactures devices for use during breast augmentation surgery. [34] On December 12, the company announced the acquisition of Repros Therapeutics , a developer of drugs for reproductive system diseases . [35]

The FDA's approval of Ozurdex was based on results from 2 randomized, double-masked, multi-center clinical studies (n = 853).  The studies demonstrated a statistically significant improvement in 3 or more lines of VA in approximately 20 to 30 % of treated patients within 60 days post-implantation compared to sham.  The duration of improvement continued for approximately 30 to 90 days and was effective in both CRVO and BRVO.  The most significant adverse effect was an increase in intra-ocular pressure that occurred in 106 patients (25 %), which peaked at 60 days and returned to baseline levels by day 180.  Three patients ( %) required laser or surgical procedures as a result.  Conjunctival hemorrhage occurred in 85 patients (20 %).  Ozurdex is the first FDA-approved therapy for ME related to retinal vein occlusion.  The proposed benefit of a sustained-release intra-vitreal corticosteroid insert such as Ozurdex is the potential for fewer injections.  Intra-vitreal injections have been associated with endophthalmitis, eye inflammation, increased intra-ocular pressure, and retinal detachments. 

Ozurdex steroid implants

ozurdex steroid implants

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