EyeWorld Asia-Pacific September 2017 Issue

Nepafenac to fight off CME by Maxine Lipner EyeWorld Senior Contributing Writer Effective against CME in patients with risk factors W hen attempting to stave off pseudopha- kic cystoid macular edema (PCME), prac- titioners often reach for an NSAID. But is this likely to be effective? In a recent study, investigators determined that the topical NSAID nepafenac 0.3% (Nevanac 0.3%, Alcon, Fort Worth, Texas) was only effective against CME in those with preoperative risk factors for the condition, 1 according to Sean McCafferty, MD , Arizona Eye Consultants, Tucson, Arizona. While nepafenac and other NSAIDs are FDA approved for fight- ing inflammation in the anterior chamber and reducing pain in the first few days after surgery, that’s not what many surgeons rely on them for, Dr. McCafferty finds. “I’ve been doing this for 20 years, and the predominant reason that I’ve used topical NSAIDs is to pre- vent PCME,” he said. “I don’t use it much for the inflammation—I use it off-label.” To determine if his col- leagues were doing the same, Dr. McCafferty ran an informal study in which he surveyed 62 cataract surgeons. “We found that 72% of them used the NSAID, not just nepafenac but any NSAID, primarily to prevent PCME,” Dr. McCafferty said. “They may use it for pain and inflammation as well, but the primary purpose was to use it off-label to prevent cystoid macular edema,” he said. With that in mind, in the re- cent study, Dr. McCafferty wanted to determine whether such NSAIDs were effective for this purpose. “We had been using nepafenac and several others before for this purpose. There was this paucity of information as to whether or not it works for the primary reason that the general ophthalmologist uses it,” he said. Previous studies had trended in that direction but were limited. “Small, sample size-controlled pro- spective studies said that there was no benefit,” Dr. McCafferty said. “The problem is they excluded the risk factors.” The drugs can be expensive, and Dr. McCafferty wanted to find out if they were actually helping prevent CME. “They can run more than [US]$200 for the patients,” he said. “Our question was, ‘Are we helping patients out with these?’” To determine this, investigators launched a study of about 1,000 patients. This was four to five times larger than any study that had been done prospectively in this manner, Dr. McCafferty said. While there were several other NSAIDs available, investigators confined the investiga- tion to one agent. “There were sev- eral of them that were potentials for this but we determined that they all had the same mechanism of action,” Dr. McCafferty said. So investigators came up with once daily nepafenac 0.3% as the drug that they would use in the double-blind trial. Patients with all risk factors for PCME were included here. “Those risk factors included anyone who had contralateral PCME, active diabetic retinopathy, retinal vein occlusion, macular hole, epiretinal membrane, or prostaglandin use in previous retinal surgery,” Dr. Mc- Cafferty said, adding that in pre- vious prospective studies all such conditions have been excluded. Studying nepafenac for PCME Study participants were ran- domized to receive either nepafenac 0.3% in a blinded bot- tle or placebo. When investigators examined results, they found that there was some impact of the drug on the condition. “What we found was that if physicians use NSAIDs on every single patient, there was a statistically significant reduced incidence of PCME,” he said. “We found that to an even greater degree in patients with risk factors, the use of the NSAID greatly reduced the incidence of PCME.” While this was determined to be well beyond anything that was statistically significant, when they excluded those with risk factors for PCME there was no statistical signifi- cance found between the two arms, Dr. McCafferty continued. “If you were to blanket NSAID use, you would get some benefit to it as far as PCME,” he said, adding, however, that for those without risk factors, using the drug made no difference in preventing PCME. For those who did have risk factors, it made a large difference. “With contralat- eral PCME, there was almost a 20-times increased risk of PCME in the fellow eye if we did not use the NSAID,” Dr. McCafferty said. The risk was 13 times for those with diabetic retinopathy or Pseudophakic cystoid macular edema (PCME) OCT images Source: Sean McCafferty, MD continued on page 46 41 EWAP CATARACT/IOL September 2017