BioCentury | Sep 7, 2015
Company News

Allergan, Regeneron sales and marketing update

...NICE published two final draft guidances recommending Eylea aflibercept from Regeneron and Ozurdex dexamethasone intravitreal implant ( SK-0503...
...can obtain a discount and with a central retinal thickness of 400 um or greater. Ozurdex...
...all forms of VEGF-A and placental growth factor ( PGF ; PlGF ). Allergan gained Ozurdex...
BioCentury | Jun 8, 2015
Company News

Actavis sales and marketing update

...The U.K.’s NICE issued a final appraisal determination (FAD) recommending Ozurdex dexamethasone intravitreal implant ( SK-0503 ) from...
...lens who did not respond to non-corticosteroids, is in line with a February preliminary appraisal. Ozurdex...
BioCentury | Jun 3, 2015
Company News

NICE issues final guidances in DME

...guidances recommending the use of Eylea aflibercept from Bayer AG (Xetra:BAYN) and Ozurdex dexamethasone intravitreal implant ( SK-0503...
...and EU for other ophthalmic indications (see BioCentury Extra, March 25) . NICE recommended that Ozurdex...
...be used only in patients with an intraocular lens who are not responsive to corticosteroids. Ozurdex...
BioCentury | Feb 23, 2015
Clinical News

Ozurdex dexamethasone intravitreal implant regulatory update

...The U.K.’s NICE issued a preliminary appraisal recommending Ozurdex dexamethasone from Allergan to treat diabetic macular...
...recommendation is restricted to patients with an intraocular lens who did not respond to non-corticosteroids. Ozurdex...
...the eye. Allergan Inc . (NYSE:AGN), Irvine, Calif. Product: Ozurdex dexamethasone intravitreal implant ( SK-0503 ) (formerly Posurdex...
BioCentury | Oct 20, 2014
Clinical News

Ozurdex dexamethasone intravitreal implant regulatory update

...FDA approved an sNDA from Allergan for Ozurdex dexamethasone intravitreal implant to expand its use to include the...
...in patients who have an artificial lens implant or who are scheduled for cataract surgery. Ozurdex...
...of the eye. Allergan Inc. (NYSE:AGN), Irvine, Calif. Product: Ozurdex dexamethasone intravitreal implant ( SK-0503 ) (formerly Posurdex...
BioCentury | Sep 15, 2014
Clinical News

Ozurdex dexamethasone intravitreal implant regulatory update

...Allergan said the European Commission expanded the label of Ozurdex dexamethasone intravitreal implant to include treatment of visual...
...retinal vein occlusion (CRVO) and treat non-infectious uveitis affecting the posterior segment of the eye. Ozurdex...
...for cataract surgery. Allergan Inc. (NYSE:AGN), Irvine, Calif. Product: Ozurdex dexamethasone intravitreal implant ( SK-0503 ) (formerly Posurdex...
BioCentury | Sep 1, 2014
Clinical News

Ozurdex dexamethasone intravitreal implant regulatory update

...EMA’s CHMP recommended expanding the label of Ozurdex dexamethasone intravitreal implant to include treatment of visual impairment due...
...retinal vein occlusion (CRVO) and treat non-infectious uveitis affecting the posterior segment of the eye. Ozurdex...
...for cataract surgery. Allergan Inc. (NYSE:AGN), Irvine, Calif. Product: Ozurdex dexamethasone intravitreal implant ( SK-0503 ) (formerly Posurdex...
BioCentury | Jul 14, 2014
Clinical News

Lucentis ranibizumab: Phase IIIb data

...of improving mean change in BCVA from baseline over 6 months vs. a 0.7 mg dexamethasone intravitreal implant...
...in the U.S., while Novartis markets it elsewhere. Allergan Inc. (NYSE:AGN, Irvine, Calif.) markets Ozurdex dexamethasone intravitreal implant...
BioCentury | Jul 14, 2014
Clinical News

Ozurdex dexamethasone intravitreal implant regulatory update

...Allergan said FDA approved an sNDA to expand the label of Ozurdex dexamethasone intravitreal implant to include treatment...
...and in the U.S. to treat non-infectious uveitis affecting the posterior segment of the eye. Ozurdex...
...Sanwa Kagaku Kenkyusho Co. Ltd. , Nagoya, Japan Product: Ozurdex dexamethasone intravitreal implant ( SK-0503 ) (formerly Posurdex...
BioCentury | Aug 5, 2013
Clinical News

Ozurdex dexamethasone intravitreal implant regulatory update

...and a Type II variation application to EMA seeking to expand the label of Ozurdex dexamethasone intravitreal implant...
...Sanwa Kagaku Kenkyusho Co. Ltd. , Nagoya, Japan Product: Ozurdex dexamethasone intravitreal implant ( SK-0503 ) (formerly Posurdex...
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