BURLINGTON, Mass., May 7, 2014 /PRNewswire/ -- Decision Resources Group finds that, ahead of the anticipated label expansion of Regeneron's Eylea for diabetic macular edema (DME) in August 2014, over half of surveyed U.S. retinal specialists and general ophthalmologists currently prescribe this anti-vascular endothelial growth factor (VEGF) agent to their intravitreal (IVT)-treated DME patients. This significant increase in prescriber base compared with 12 months ago suggests that, in a market with only one approved therapy, physicians are eager to gain early experience with Eylea prior to approval. In fact, physicians already rate their satisfaction with Eylea similarly to that of the other anti-VEGF agents, Roche/Genentech's Avastin, the typical first-line treatment approach for DME, and Roche/Genentech's Lucentis 0.3 mg, which is the only FDA-approved therapy for DME.
Other key findings from the TreatmentTrends: Diabetic Retinopathy/Diabetic Macular Edema 2014 (US) report:
- Patient share for Lucentis and Avastin: After a period of rapid growth following the approval in August 2012 of the 0.3 mg dose for DME, physician-reported patient share for Lucentis among IVT-treated DME patients has remained stable compared to twelve months ago and continues to trail that of patient share leader Avastin. Avastin's dominance as the most preferred treatment approach for DME is fueled by physicians' positive perceptions related to its efficacy and its low cost relative to the other anti-VEGF agents in this price-sensitive market.
- Anticipated prescribing of Iluvien: In line with Alimera Sciences's NDA filing for Iluvien, a sustained-release steroid IVT implant, for the treatment of chronic DME, physicians anticipate prescribing the implant most often as a second- or later-line treatment option. While the majority of physicians are interested in learning more about Iluvien, presumably due to its infrequent dosing, their concern about the risk of cataracts with long-acting steroid implants will likely limit the drug's uptake.
Comments from Decision Resources Group Analyst Emma McFadden, Ph.D.:
- "Overall satisfaction with Allergan's Ozurdex, approved for uveitis and macular edema following retinal vein occlusion and currently under FDA review for a DME label expansion, has increased significantly over the past 12 months as has its performance rating on proven sustained efficacy, possibly as a result of clinical trial data availability in DME. Moreover, this long-acting steroid implant has experienced significant growth in prescriber base and physician-reported DME patient share compared with 12 months ago, with much of this growth coming from use among retinal specialists rather than general ophthalmologists."
- "Although few surveyed physicians are aware of Ampio Pharmaceuticals' Optina, this oral low-dose danazol product is second only to Eylea in its perceived value in the treatment of DME among profiled products in development. Much of this value is driven by Optina's oral formulation―unique in this market―and novel mechanism of action."
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