RX PERSPECTIVE

A more efficacious postoperative NSAID option in Ilevro

Faster dissolution, increased concentration and better pH balance than previous nepafanac agents.

By Uday Devgan, MD

Uday Devgan, MD, FACS, is in private practice at Devgan Eye Surgery, Los Angeles (www.DevganEye.com). His e-mail is devgan@gmail.com. Disclosures: Dr. Devgan is a paid consultant to Alcon and Bausch & Lomb, and formerly to Allergan and Ista Pharma, all of which make ophthalmic NSAIDs. Dr. Devgan has no direct financial interest in the products mentioned.

And just like that, it happened — a ruptured posterior capsule with vitreous prolapse. What started as a seemingly routine case suddenly became far more complex.

This patient would now be at a higher risk for postoperative complications such as prolonged inflammation, pain, infection, retinal detachment and macular edema. However, with efficacious postoperative medications and careful management, the eye healed well and the patient recovered excellent vision.

This case emphasized to me the importance of the postoperative regimen and that visual results after surgery are equal parts surgical technique and patient healing, the latter in which topical medications play a key role. To deliver the best results with cataract surgery, I want to choose the best-of-class products for each step.

Of particular importance is the NSAID I prescribe to control inflammation and pain, which needs to be efficacious as well as convenient with once-daily dosing.

For pain and inflammation after cataract surgery, Ilevro uses smaller particles and a greater concentration of the active ingredient nepafanac than Nevanac.

A NEWER NSAID OPTION

For the past year, I have used Ilevro (nepafanac 0.3% suspension, Alcon, Fort Worth, Texas) with excellent results. The active molecule in Ilevro is nepafanac, the same used in Nevanac (Alcon), a drug with a long track record of safety and efficacy.

In Ilevro, the concentration is three times greater and the formulation possesses numerous improvements compared to Nevanac. The particles of nepafanac are now 40% smaller in Ilevro, which allows for faster dissolution. This gives double the intraocular concentration compared to Nevanac after a single dose.

Ilevro has a more neutral pH than Nevanac, and it possesses agents often found in artificial tears, such as carboxymethylcellulose and propylene glycol, to increase viscosity.

RESULTS OF PIVOTAL TRIALS

The pivotal trials for Ilevro were truly remarkable for multiple reasons: The efficacy in controlling postoperative inflammation was excellent; one trial was the largest NSAID trial in ophthalmology with more than 2,000 patients. The trials even included a comparison of Ilevro once daily to Nevanac TID that showed non-inferiority.

The one thing that convinced me to try Ilevro in my patients was the huge difference in inflammation control between the Ilevro arm and the placebo arm of the trials.

Most FDA pivotal trials of NSAIDs are very similar: Patients have cataract surgery, then they are randomized to receive the NSAID or the placebo, and then the groups are examined at the two-week postoperative visit to determine what percentage of patients have zero inflammation as measured by anterior-chamber cells and flare.

For Ilevro, 61% of patients had zero inflammation at two weeks compared to 24% of in the vehicle/placebo group — a difference of 37 percentage points, the largest margin I have seen for any NSAID pivotal trial in ophthalmology.

MANAGING INFLAMMATION OF THE POSTERIOR SEGMENT

While the pivotal trials looked at anterior-segment inflammation, I am also concerned with posterior-segment inflammation because of the risk of cystoid macular edema postoperatively. The label indication for Ilevro and other nepafanac formulations in the United States state that it is solely for the control of postoperative pain and inflammation.

Outside of the United States, nepafanac has been granted an indication to reduce the risk of postoperative macular edema in diabetic patients. In trial data, at the 90-day mark after cataract surgery, nepafanac gave a fivefold reduction in the risk of macular edema (just 3.2%) compared to vehicle (16.7%).

While the official Ilevro indication in the United States is for two weeks of postoperative use, I routinely give it to my patients for four weeks after routine cataract surgery. With the standard Ilevro bottle, patients can typically get about 30 to 32 doses, which is sufficient for the entire four weeks of therapy without the need for a refill from the pharmacy.

In complicated cases with a higher risk of macular edema, such as patients with diabetic retinopathy or prior uveitis, I will continue to use Ilevro for even longer while closely monitoring their healing and macular thickness. While the risks of longer-term NSAID use are low, carefully monitoring these complicated patients makes good clinical sense.

As surgeons, we want what is best for our patients, and that means a quick recovery of excellent vision after cataract surgery with excellent control of inflammation and pain. The vast majority of the time, we can accomplish that with our surgical techniques and good patient healing, as modulated by NSAIDs such as Ilevro. OM

Editor’s note: This article represents Dr. Devgan’s personal experience and opinion. The manufacturers of the agents mentioned here have not endorsed or promoted the off-label uses he discusses.