Managed Healthcare Executive

FDA issues third rejection of bevacizumab to treat wet AMD

The FDA issued a third complete response letter for ONS-5010/Lytenava, requesting confirmatory efficacy evidence for wet AMD treatment. Lytenava is an ophthalmic bevacizumab formulation, potentially ...

Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab ...
Pharmaceutical Technology on MSN

Outlook Therapeutics receives FDA response on ONS-5010 for wet AMD

The ONS-5010 BLA resubmission was supported by data from the NORSE programme, including NORSE TWO and other trials.
The American Journal of Managed Care

Future Treatments for AMD Could Mitigate Burden on Patients

Reducing the number of intravitreal injections to treat age-related macular degeneration (AMD) is a top priority in current treatment research, says Paul Hahn, MD, PhD. The future of treating ...