JAN 2012

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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46 EW FEATURE Retina co-morbidity for the anterior segment surgeon January 2012 Pharmaceutical focus February 2011 Therapy on the anti-VEGF frontier by Maxine Lipner Senior EyeWorld Contributing Editor which monthly anti-VEGF injec- tions are obsolete. "Anything that reduces that treatment burden is huge," he said. CATT and its implications Lucentis and Avastin remain key anti-VEGF players here. The recent Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) closely examined how these two valuable agents stack up against one another. The two drugs tended to be administered differently from the start, according to Daniel F. Martin, M.D., chairman, Cole Eye Institute, Cleveland Clinic. Lucentis had been studied as a monthly injec- tion, while the predominant treat- ment pattern for Avastin was on an as-needed basis. In CATT both drugs fared simi- larly. "We showed that Lucentis and Avastin were nearly identical for all visual acuity metrics that we looked at, at 1 year," Dr. Martin said. "We also showed that PRN dosing could produce an excellent visual result, but on average it was about two let- ters less than was achieved with monthly dosing." Another finding was that both Update on retinal sparing drugs for AMD A nti-VEGF therapy to fight neovascular eye disease recently got a boost when on November 18, 2011, EYLEA (Regeneron Pharmaceuticals, Tarrytown, N.Y.), also known as VEGF Trap-Eye, received FDA approval for wet AMD cases. This is one new anti-VEGF gaining ground in an area that has been dominated by Avastin (bevacizumab, Genentech, South San Francisco) and Lucentis (ranibizumab, Genentech), consid- ered breakthrough drugs in their own right for AMD patients. Investi- gators are also honing in on other drugs such as integrin peptide ther- apy. EyeWorld asked practitioners to offer their insights on these valuable drugs. The approval of EYLEA is con- sidered a coupe for patients since it can be administered much less fre- quently than other anti-VEGFs. It has an additional mechanism of ac- tion, according to Peter K. Kaiser, M.D., professor of ophthalmology, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland. "EYLEA is similar to other anti-VEGF agents on the market such as Lucentis and Avastin in that it blocks isoforms of VEGF, but in addition it blocks pla- centa growth factor, which is in and of itself an angiogenic pathway," Dr. Kaiser said. The other difference is the way that it binds to VEGF. "It binds much tighter than Lucentis and Avastin, which theoretically would allow it to last longer in terms of its biologic activity," he said. "That was borne out in the clinical study where it went head-to-head against Lucentis given monthly." In the study, EYLEA was given after a load dose just every other month and boasted equal results in vision and safety. It had essentially identical results to Lucentis given monthly. Dr. Kaiser sees this as en- abling practitioners to dose patients every other month as opposed to every month or even less. "In all likelihood since most of us don't in- ject Lucentis every month—we use some sort of as-needed protocol— the fact that EYLEA lasts longer will hopefully make that as-needed dif- ference even greater," he said. No red flags were raised in the clinical study in terms of safety. He sees approval of EYLEA as a potential boon for patients and prac- titioners alike. He pointed out that patients who have been taking Avastin monthly could be switched to EYLEA every other month. For practitioners, he thinks that it will unclog the clinics a bit, and for pa- tients and their families it will ulti- mately mean fewer injections and fewer trips to the office. Dr. Kaiser looks to a future in drugs produced an immediate and substantial decrease in fluid on OCT, but there was a slight difference be- tween the two. "At 1 year there were more eyes that were completely dry with Lucentis than eyes treated with Avastin," Dr. Martin said. "The ab- solute difference in the number of those eyes was small and the average amount of fluid that remained was extremely small—its clinical rele- vance was not clear." Dr. Martin stressed that it re- mains unclear whether the two-let- ter difference between PRN and monthly dosing will be wider at fol- low-up or whether the fact that there was a difference in the amount of fluid between Lucentis and Avastin treated eyes will ultimately matter. In terms of safety, CATT found no difference in terms of death, my- ocardial infarction, or stroke. How- ever, there were more patients who received Avastin who experienced a serious adverse event (SAE). The dif- ference in SAEs was 24% for Avastin and 19% for Lucentis. "This may be due to chance, it may be due to an imbalance at baseline, or it may rep- resent a real risk that we still don't

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