Based on positive data from an NIH-sponsored Phase III trial,
it's likely that Lucentis ranibizumab will become part of the standard of care
even before being approved for diabetic macular edema. Indeed, the American
Academy of Ophthalmology is likely to incorporate the drug into its
national treatment guidelines in a matter of weeks.
As a result, Lucentis or
another VEGF inhibitor will become a de facto comparator in trials of
other agents, which will make demonstrating an improvement over standard care
much more difficult for companies following in the clinic.