Nepafenac reduces risk for macular edema after cataract surgery in select patients

Two studies have shown the benefits of topical nepafenac 0.3% in reducing the risk for macular edema and pseudophakic cystoid macular edema in certain patients.

For patients who exhibit risk factors for pseudophakic cystoid macular edema (PCME), the adjunctive use of nepafenac with topical steroids can significantly reduce their chances of developing the condition after phacoemulsification, Sean J. McCafferty, MD, told Ocular Surgery News.

“It’s the most common complication. Even though it’s not a major complication — PCME is self-limiting and will typically resolve — it’s very disconcerting to the patient and the surgeon who are expecting good visual acuity after uncomplicated surgery. They may need to go for a month, or even a few months, without good vision. It can even be an unresolving chronic condition, but very rarely,” McCafferty said.

In an independent, prospective, randomized, double-masked, placebo-controlled study, McCafferty and colleagues divided 1,000 eyes into a placebo group or a nepafenac group to examine the effect of the NSAID. Ilevro (nepafenac 0.3%, Alcon) or placebo was applied once daily for 5 weeks postoperatively to patients who underwent routine cataract surgery.

PCME was the most common complication associated with routine cataract surgery. In total, 4.2% of patients in the cohort with preoperative risk factors, such as contralateral PCME, diabetic retinopathy, retinal vein occlusion, macular hole or epiretinal membrane, developed PCME compared with 2% of patients without preoperative risk factors, McCafferty said.

Three hundred eight patients with preoperative risk factors who received nepafenac 0.3% had a significantly reduced incidence of PCME compared with the placebo group, quantified by a relative risk for each factor. Six hundred ninety-two patients without preoperative risk factors, however, did not experience a significant reduction in PCME.

Rishi P. Singh

“If you want to use NSAIDs across the board, this study shows you’ll have a decreased incidence of PCME. If your sole concern is PCME, you could exclude patients who don’t have risk factors, which is more than 70% in most practices. The one thing that is surprising to us is the striking difference between the two groups. If you have the risk factors, nepafenac is definitely a benefit mitigating PCME. If you don’t, then it’s really not at all,” McCafferty said.

Diabetic retinopathy

Nepafenac was found to have a similar effect on reducing the rate of macular edema in patients with diabetic retinopathy undergoing cataract surgery. Patients with diabetic retinopathy develop macular edema at a much higher rate after cataract surgery than those who do not have diabetic retinopathy, Rishi P. Singh, MD, told OSN.

The use of nepafenac significantly reduced the rates of macular edema and increased the percentage of patients with a 15 letter or more improvement of best corrected visual acuity 90 days postoperatively, Singh said.

“We looked at patients with and without nepafenac following surgery to see if it improved outcomes. We found that more patients had a three-line gain of visual acuity and reduction of macular edema occurrences. In my mind this was a validation of nonsteroidals in this population of patients with diabetic retinopathy. It’s not for the general patient who doesn’t have a risk factor for macular edema,” he said.

Greater BCVA improvement

Singh and colleagues conducted two prospective, randomized, double-masked, vehicle-controlled phase 3 studies comparing the effects of topical nepafenac or vehicle once daily in patients with diabetic retinopathy undergoing cataract surgery.

Six hundred fifteen patients in study 1 and 605 patients in study 2 were randomly assigned 1:1 to nepafenac or vehicle once daily starting the day before surgery and continuing 90 days postoperatively. Patients were evaluated for postoperative BCVA and macular edema rates.

In study 1, patients who received nepafenac experienced a significantly lower diagnosis rate (2.3%) of macular edema compared with those who received vehicle (17.3%). The same was found in study 2, as 5.9% of patients who received nepafenac were diagnosed with macular edema compared with 14.3% of patients who received vehicle.

Additionally, a greater percentage of patients who received nepafenac experienced a BCVA improvement of 15 letters or more in both studies compared with patients who received vehicle.

Nepafenac is only effective in patients with macular edema risk factors such as retinovascular disorders such as diabetic retinopathy and any type of retinal vascular diseases, Singh said. – by Robert Linnehan

Disclosures: McCafferty reports unrelated financial support from AMO and Intuor Technologies. Singh reports he is a consultant for Alcon, Regeneron, Genentech, Zeiss and Shire and receives financial support from Genentech/Roche, Regeneron and Apellis.

Two studies have shown the benefits of topical nepafenac 0.3% in reducing the risk for macular edema and pseudophakic cystoid macular edema in certain patients.

For patients who exhibit risk factors for pseudophakic cystoid macular edema (PCME), the adjunctive use of nepafenac with topical steroids can significantly reduce their chances of developing the condition after phacoemulsification, Sean J. McCafferty, MD, told Ocular Surgery News.

“It’s the most common complication. Even though it’s not a major complication — PCME is self-limiting and will typically resolve — it’s very disconcerting to the patient and the surgeon who are expecting good visual acuity after uncomplicated surgery. They may need to go for a month, or even a few months, without good vision. It can even be an unresolving chronic condition, but very rarely,” McCafferty said.

In an independent, prospective, randomized, double-masked, placebo-controlled study, McCafferty and colleagues divided 1,000 eyes into a placebo group or a nepafenac group to examine the effect of the NSAID. Ilevro (nepafenac 0.3%, Alcon) or placebo was applied once daily for 5 weeks postoperatively to patients who underwent routine cataract surgery.

PCME was the most common complication associated with routine cataract surgery. In total, 4.2% of patients in the cohort with preoperative risk factors, such as contralateral PCME, diabetic retinopathy, retinal vein occlusion, macular hole or epiretinal membrane, developed PCME compared with 2% of patients without preoperative risk factors, McCafferty said.

Three hundred eight patients with preoperative risk factors who received nepafenac 0.3% had a significantly reduced incidence of PCME compared with the placebo group, quantified by a relative risk for each factor. Six hundred ninety-two patients without preoperative risk factors, however, did not experience a significant reduction in PCME.

Rishi P. Singh

“If you want to use NSAIDs across the board, this study shows you’ll have a decreased incidence of PCME. If your sole concern is PCME, you could exclude patients who don’t have risk factors, which is more than 70% in most practices. The one thing that is surprising to us is the striking difference between the two groups. If you have the risk factors, nepafenac is definitely a benefit mitigating PCME. If you don’t, then it’s really not at all,” McCafferty said.

Diabetic retinopathy

Nepafenac was found to have a similar effect on reducing the rate of macular edema in patients with diabetic retinopathy undergoing cataract surgery. Patients with diabetic retinopathy develop macular edema at a much higher rate after cataract surgery than those who do not have diabetic retinopathy, Rishi P. Singh, MD, told OSN.

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The use of nepafenac significantly reduced the rates of macular edema and increased the percentage of patients with a 15 letter or more improvement of best corrected visual acuity 90 days postoperatively, Singh said.

“We looked at patients with and without nepafenac following surgery to see if it improved outcomes. We found that more patients had a three-line gain of visual acuity and reduction of macular edema occurrences. In my mind this was a validation of nonsteroidals in this population of patients with diabetic retinopathy. It’s not for the general patient who doesn’t have a risk factor for macular edema,” he said.

Greater BCVA improvement

Singh and colleagues conducted two prospective, randomized, double-masked, vehicle-controlled phase 3 studies comparing the effects of topical nepafenac or vehicle once daily in patients with diabetic retinopathy undergoing cataract surgery.

Six hundred fifteen patients in study 1 and 605 patients in study 2 were randomly assigned 1:1 to nepafenac or vehicle once daily starting the day before surgery and continuing 90 days postoperatively. Patients were evaluated for postoperative BCVA and macular edema rates.

In study 1, patients who received nepafenac experienced a significantly lower diagnosis rate (2.3%) of macular edema compared with those who received vehicle (17.3%). The same was found in study 2, as 5.9% of patients who received nepafenac were diagnosed with macular edema compared with 14.3% of patients who received vehicle.

Additionally, a greater percentage of patients who received nepafenac experienced a BCVA improvement of 15 letters or more in both studies compared with patients who received vehicle.

Nepafenac is only effective in patients with macular edema risk factors such as retinovascular disorders such as diabetic retinopathy and any type of retinal vascular diseases, Singh said. – by Robert Linnehan

Disclosures: McCafferty reports unrelated financial support from AMO and Intuor Technologies. Singh reports he is a consultant for Alcon, Regeneron, Genentech, Zeiss and Shire and receives financial support from Genentech/Roche, Regeneron and Apellis.