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Eye Disease Drug

All articles tagged with #eye disease drug

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

health2 years ago•0 min saved

Apellis Investigates Needle Safety Concerns in Eye Disease Drug

Apellis Pharmaceuticals has identified internal structural variations in the needle used to prepare syringes of its eye disease drug Syfovre as a possible cause of severe eye inflammation reported in patients. However, the company has not definitively linked the needle to the cases. Despite one additional case of the severe side effect, the overall frequency remains rare, leading to a 30% rise in Apellis shares as investors believe the safety crisis is abating.

via STAT|

#apellis-pharmaceuticals #eye-disease-drug #health