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EyewireTV — Ozurdex Expanded Indication, Iluvien FDA Approval, Avedro CXL Resubmission

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In this week’s EyewireTV, the FDA approves an expanded indication for Allergan’s Ozurdex (dexamethasone intravitreal implant 0.7 mg) for the treatment of diabetic macular edema; and Alimera Sciences’ Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg) receives FDA approval for the treatment of DME in patients who were previously treated with corticosteroids and did not have a clinically significant rise in IOP. Also, Avedro resubmits a new drug application to the FDA for its riboflavin ophthalmic solution and KXL System.

Omeros Announces Initiation of Planned Pharmacokinetic Substudy in OMS302 Phase 3 Clinical Program

From Omeros Corp.

Omeros Corp. announced the initiation of the planned pharmacokinetic (PK) substudy in its phase 3 clinical program evaluating OMS302 in patients undergoing intraocular lens replacement surgery. Omeros is conducting the PK substudy to confirm the low levels of systemic exposure previously observed in preclinical studies of the drug product. Blood sa...

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Wednesday, October 01, 2014

Show last days of articles

Johnson & Johnson Vision Care Announces New -2.75 CYL for Ac...

From Johnson & Johnson Vision Care — 10/1/2014

Johnson & Johnson Vision Care announced that Acuvue Oasys brand contact lenses for astigmatism is now the first and only silicone hydrogel toric c...Full story

Marco Expands its Management Team

From Marco — 10/1/2014

Marco, a provider of diagnostic equipment for the eye care market, has announced it is expanding its management team. Below are descriptions of new ma...Full story

Aerie Announces Closing of $125 Million Convertible Notes Fi...

From Aerie Pharmaceuticals — 10/1/2014

Aerie Pharmaceuticals announced that it has closed its $125 million financing with Deerfield Management Company LP, a current Aerie shareholder. Under...Full story

Detailing Financial Links of Doctors and Drug Makers

From The New York Times — 10/1/2014

Pharmaceutical and device makers paid doctors roughly $380 million in speaking and consulting fees, with some doctors reaping over half a million doll...Full story

Xoma Initiates U.S. Clinical Trial of Gevokizumab in Patient...

From Xoma — 10/1/2014

Xoma Corp. announced that its EYEGUARD-US supplemental clinical study is open for enrollment to patients at study sites located in the United States. ...Full story

Roche Initiates Phase 3 Trials for Lampalizumab, First Poten...

From Medical News Today — 10/1/2014

Roche has announced that phase III clinical studies have been initiated for lampalizumab, an investigational drug for geographic atrophy (GA), the adv...Full story

Tuesday, September 30, 2014

Horus Pharma and NovaMedica Sign Agreement to Market a Portf...

From NovaMedica LLC — 9/30/2014

NovaMedica LLC and Horus Pharma SL have signed a partnership agreement that grants NovaMedica exclusive rights to commercialize a portfolio of product...Full story

Glaucoma Cure May Lie in Targeting 'Stiff Cells' That Impede...

From Medical News Today — 9/30/2014

A unique international study that is unusual because it points to a mechanical feature of cells as a cause of disease suggests glaucoma arises when ce...Full story

Diseases Result From Gene Mutations Linked to a Molecular Mo...

From Medical News Today — 9/30/2014

Another mystery of the human body has been solved by scientists who have identified how a molecular motor essential for human development works. They ...Full story

Monday, September 29, 2014

Allergan Announces FDA Approves Revised Indication for Ozurd...

From Allergan — 9/29/2014

Allergan announced that the FDA has approved Ozurdex (dexamethasone intravitreal implant) 0.7 mg, a sustained-release biodegradable steroid implant, f...Full story

Nicox Glaucoma Drug Effective in Late-Stage Studies

From Medscape Ophthalmology — 9/29/2014

French pharmaceutical firm Nicox unveiled positive topline Phase 3 results for its glaucoma drug on Thursday and said, if approved by regulators, the ...Full story

Alimera Sciences Provides Details on FDA Approval of Iluvien...

From Alimera Sciences — 9/29/2014

Alimera Sciences announced that it will hold a conference call to provide additional information regarding the recent approval by the FDA of Iluvien f...Full story

Scientists are Developing Eye Drops to Treat Molecular Basis...

From Medical News Today — 9/29/2014

Northwestern Medicine scientists have discovered a novel cause of glaucoma in an animal model, and related to their findings, are now developing an ey...Full story

Friday, September 26, 2014

Alimera Sciences Receives FDA Approval For Iluvien, The Firs...

From Eyewiretoday.com — 9/26/2014

Alimera Sciences announced that the FDA has approved Iluvien for the treatment of diabetic macular edema (DME) in patients who have been previously tr...Full story

Immediate Sequential Cataract Surgery Reduces Ophthalmologis...

From Medscape Ophthalmology — 9/26/2014

Lower current reimbursement rates for immediate sequential cataract surgery (ISCS) compared with delayed sequential cataract surgery (DSCS) result in ...Full story

Bausch + Lomb Announces Results from Phase 3 Study of Sub-Mi...

From Bausch + Lomb — 9/26/2014

Bausch + Lomb announced that its next generation sub-micron gel formulation of loteprednol etabonate was statistically superior to placebo (vehicle ge...Full story

UK Eye Health Companies Form Industry Vision Group to Improv...

From Medical News Today — 9/26/2014

A number of companies have joined together to form the Industry Vision Group (IVG), which brings together pharmaceutical and medical technology compan...Full story

Brain Mechanism Underlying the Recognition of Hand Gestures ...

From Medical News Today — 9/26/2014

Does a distinctive mechanism work in the brain of congenitally blind individuals when understanding and learning others' gestures? Or does the same me...Full story

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