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Allergan’s AGN-745 will likely have difficulty gaining market share over Genentech’s Lucentis - and similar drug Avastin used off-label - in the treatment of wet-AMD, physicians told Pharmawire.
In development with Sirna Therapeutics, AGN-745 is in Phase II trials as a treatment for the wet form of age-related macular degeneration (wet-AMD). AGN-745 is designed to target vascular endothelial growth factor 1 (VEGF-1), which is involved in the growth of new blood vessels. The goal is to prevent angiogenesis by targeting VEGF-1 with small interfering RNA (siRNA), a technology that relies on gene silencing.
In Phase I trials, visual acuity stabilization occurred in all subjects after eight weeks with a single injection, and a decrease in the thickness of the fovea showed that biological activity was present.
Dr Michael Samuel, a retina and AMD specialist at The Retina Group in Columbus, Ohio, said that while siRNA treatments do show promise, they do not seem to be more effective than the current standards of care. With the effectiveness of Avastin and Lucentis, the market is very difficult to enter, he added.
AGN-745 has not shown any advantage over the current standard of care, which will make gaining market share very difficult, Samuel said. He further noted that while the concept of AGN-745 is strong and, thus far, the clinical trials have shown that the drug is safe, physicians have not yet seen the efficacy advantage that would convince them to move away from Avastin and Lucentis.
Allergan did not respond to a request for comment.
Dr Matt Benz, a retina specialist at The Methodist Hospital in Houston, said there was a lot of initial excitement about siRNA, but this enthusiasm has tapered off significantly. The results seen with siRNA therapies have been less than impressive thus far, he added.
A successful head-to-head trial against Avastin or Lucentis is the only way to gain any market share for this new drug, said Dr Ivan Suner, a retina and macula specialist at Retina Associates in Tampa Bay, Florida. The most likely road to FDA approval and gaining market share at this point is a shorter treatment duration, as pure efficacy equivalence will not be enough, said Suner.
Dr Justin Brown, a retina surgeon for the Charlotte Eye Ear Nose & Throat Associates, said he did not think Allergan’s drug is necessarily going to be more efficacious than Lucentis or Avastin, but an advantage would be that it could be administered less frequently.
Brown said that many physicians believe that AGN-745 is not going to be useful for the VEGF already in the eye, but could be useful in more of a maintenance role to keep VEGF from reoccurring, as siRNA turns off that gene. Therefore, a patient could initially receive Lucentis and then use AGN-745 as maintenance therapy to prevent further disease progression.
Allergan has a market cap of USD 12.24bn.
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