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Wet Age Related Macular Degeneration

All articles tagged with #wet age related macular degeneration

healthcare2 years ago•1 min saved

FDA Rejects Outlook Therapeutics' Eye Disease Drug, Stock Plummets

The US FDA has declined to approve Outlook Therapeutics' experimental eye disease drug, citing manufacturing issues observed during pre-approval inspections. The drug, ONS-5010, is being developed as an injection for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases. Outlook Therapeutics will request a meeting with the FDA to address the issues, while the European Medicines Agency is set to begin its review process for the drug.

via Reuters|

#eye-disease-drug #fda #healthcare

healthcare2 years ago•0 min saved

Regeneron faces FDA rejection and stock slump over manufacturing and contractor issues.

The FDA rejected Regeneron's new 8-mg version of Eylea due to an ongoing review of inspection findings at a third-party filler, dealing a major blow to the company's attempt to expand the use of its eye injection for the treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The company had sought to speed up the FDA's review of this application with a priority review voucher, which typically costs about $100 million.

via Endpoints News|

#diabetic-macular-edema #eylea #fda