BioCentury

7:00 AM GMT, May 17, 2010
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Product Development

Seeing the Game Change in DME

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.

Laser therapy has been SOC for diabetic macular edema (DME) for 25 years. It is used to cauterize leaky ocular blood vessels, thereby slowing the deterioration of the tissue underneath the retina and, in turn, slowing vision loss.

Lucentis is already marketed for wet age-related macular degeneration (AMD) by Roche's Genentech Inc. unit and Novartis AG. The mAb fragment against VEGF inhibits formation of blood vessels.

Results from the NIH trial published last month in Ophthalmology,the journal of the American Academy of Ophthalmology (AAO), showed Lucentis plus prompt or deferred laser therapy significantly improved best corrected visual acuity (BCVA) from baseline at one year vs. laser alone (p<0.001 for

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