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May 17, 2010
 |  BioCentury  |  Product Development

Seeing the Game Change in DME

NIH study will make Lucentis standard of care to treat diabetic macular edema

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 both).

The study included two Lucentis arms, one in which patients received laser directly following the drug injection and another that received laser at least 24 weeks later.

Specifically, 50% and 47% of patients receiving 0.5 mg intravitreal Lucentis plus prompt or deferred laser experienced a two-line (>=10 letters) improvement, compared to 28% of patients receiving laser alone. Two-year visual acuity outcomes were similar to one-year outcomes. The study enrolled 691 patients in the U.S.

Also, 30% and 28% of patients receiving Lucentis plus prompt or deferred laser therapy achieved a three-line improvement at one year, vs. 15% of patients given laser therapy alone.

For patients with DME, a two-line difference in visual acuity can mean the difference between being able or unable to perform everyday tasks, according to Joan Miller, chief and chair of ophthalmology at the Massachusetts Eye & Ear Infirmary.

"It depends where a patient starts, but if your vision is still in a reasonable range, then a two-line vision change will allow you to drive or facilitate reading. So it is clearly a clinically substantial measure," she told BioCentury.

"These results really are a game-changer," said...

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