September 2009




New generation NSAID shows promise

by Maxine Lipner Senior EyeWorld Contributing Editor


Topical Nevanac offers new CME treatment option

For many patients with cystoid macular edema (CME) the topical non-steroidal anti-inflammatory drug (NSAID) Nevanac (nepafenac 0.1%, Alcon, Fort Worth, Texas) may be the answer. Results from a recent retrospective study published in the January 2009 issue of Clinical Ophthalmology indicate that the Nevanac treatment can be effective in acute pseudophakic CME cases as well as uveitic and chronic/recalcitrant CME, according to Seenu M. Hariprasad, M.D., associate professor and director of clinical research, Department of Surgery Section of Ophthalmology and Visual Science, University of Chicago, Chicago.

Dr. Hariprasad was hopeful that Nevanac could be effective against post-op CME based on the fact that older generation NSAIDs had shown some success. He felt that the pharmacologic structure of the drug would only enhance its action in such cases. “Older generation agents inhibit COX-1 preferentially, and the new generation agents inhibit COX-2 preferentially,” Dr. Hariprasad said. “Using new generation NSAIDs made pharmacologic sense to me because COX-2 is the COX isoform that is induced in the eye after trauma.”

Included in the retrospective study were 22 CME cases that had been treated with nepafenac 0.1%. Of those, three were acute pseudophakic CME cases, 13 were chronic/recalcitrant, and six concerned uveitic CME. Investigators found that within six months of treatment, there was a mean improvement in retinal thickness of 227 microns in the uveitic CME cases, with mean best corrected vision showing gains of 0.36 logMAR. After just 4 to 10 weeks on nepafenac the three acute CME cases showed a mean improvement in retinal thickness of 134 microns. Two of the 3 acute cases showed an improvement in best corrected vision of 0.16 and 0.22 logMAR; however, due to underlying retinal pigment epithelial changes, the third patient showed no such gains. Use of nepafenac in the 13 chronic cases resulted in a mean improvement in best-corrected visual acuity of 0.33 logMAR, with retinal thickness likewise improving by 178 microns.

Paradigm shift

Nevanac holds solid promise for treatment here. As a result of the new agent, Dr. Hariprasad sees a paradigm shift in the way CME is now handled. “In the past, surgeons would use intravitreal Avastin [bevacizumab, Genentech, South San Francisco, Calif.] and intravitreal/periocular steroids to treat this disease,” he said. “So patients would initially be on old generation NSAID therapy and Pred Forte (prednisolone, Allergan, Irvine, Calif.). When they failed this treatment then they would be converted to injections.” Now Nevanac has a prominent rung on the stepwise ladder approach. “For patients who come into my clinic who have failed traditional treatment for cystoid macular edema with Acular [ketorolac tromethamine, Allergan, Irvine, Calif.] and with Pred Forte [prednisolone acetate, Allergan] topically, we stop everything and start Nevanac monotherapy,” Dr. Hariprasad said. “We put patients on Nevanac three times a day for six weeks.” At that point the patient is reevaluated. “If the patient has a great response, that’s wonderful,” Dr. Hariprasad said. “If the patient has a partial response, then we have to discuss whether we should continue topical therapy on Nevanac or whether we should switch to the sledgehammers—intravitreal Avastin or intravitreal Kenalog [triamcinolone, Bristol-Myers Squibb, New York].”

CME by the numbers

In about one-third of cases, Nevanac alone usually suffices. “I would say that about 35% of patients respond to topical Nevanac in the first six weeks,” Dr. Hariprasad said. “Approximately 50% really need the sledgehammers at six weeks; they need intravitreal Avastin and intravitreal Kenalog to suppress their disease.” Dr. Hariprasad finds that an additional 15% of patients ultimately need surgery for retained lens fragments, epiretinal membranes, vitreomacular traction, vitreous prolapse into the anterior chamber, or IOL repositioning/removal.

Besides CME, use of Nevanac holds promise for other ocular conditions as well. “It’s very rare in retina to have a topical drop that has a positive effect on the macula, and this drug needs to be investigated for other ocular disease states,” Dr. Hariprasad said. “In my opinion, cystoid macular edema is at the top of the list, but Nevanac could decrease the treatment burden from intravitreal injections for other diseases, such as diabetic macular edema and exudative age-related macular degeneration.” The drug also has potential for retinal vein occlusions and uveitis as well. “Further studies are clearly warranted to pursue different avenues in the use of this drug to improve our outcomes in patients.”

For the future, Dr. Hariprasad urges keeping an open mind to new medications and techniques. “We have new generation agents that need to be explored to maximize outcomes in patients with macular diseases such as cystoid macular edema,” he said. “As time goes on, it’s very important to adopt new technologies and explore new options instead of being fixated on what we were doing in the past.”

Editors’ note: Dr. Hariprasad has financial interests with Alcon (Fort Worth, Texas), Bayer (Leverkusen, Germany), Genentech (San Francisco), Pfizer (New York), and Takeda Pharmaceuticals (Deerfield, Ill.).

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New generation NSAID shows promise New generation NSAID shows promise
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