During the 2013 American Society of Cataract and Refractive Surgery Annual Meeting in San Francisco, several new surgical and pharmaceutical advances were on display. One of the more mentionable pharmaceutical breakthroughs was Ilevro from Alcon Laboratories.
While similar to Nevanac in generic name ‘nepafenac’, that is where the similarities end. Though the nepafenac molecule is used, the particle has been ground down approximately 40%, allowing for faster dissolution. Furthermore, the concentration has been increased to 0.3% and guar gum has been added to increase viscosity. These changes have enacted significant changes in bioavailability; after a single dose, the Cmax and area under the curve in aqueous humor were approximately 2-fold higher than with Nevanac. This has all allowed decreased dosing requirements – from TID to effectively qd dosing.
Using the same prodrug technology, the nepafenac molecule first enters the cornea, delivering some analgesic effect. As it penetrates the intraocular tissues, hydrolysis converts the molecule into amfenac, the more potent form of the molecule. In this manner, efficacy is maximized at targeted sites within the anterior chamber.
So the big question is whether this new nepafenac can be as effective an NSAID at QD dosing that Nevanac is at TID, and the answer is simply yes.
In the largest clinical trial to date on an NSAID—a study with more than 2,000 subjects enrolled—patients undergoing cataract surgery were double blindly randomized to receive Nevanac, Ilevro, or their respective vehicles. In the end there were absolutely no statistically significant differences between patients who received Nevanac and those who received Ilevro. In essence, patients can now receive the same results they experienced with Nevanac with once-daily dosing with Ilevro.
Excited by the clinical data presented, I decided to use Ilevro for my post-cataract patients. To date, I have been incredibly impressed by the results. Patients are incredibly comfortable and I do believe it is the same efficacy as Nevanac TID. I prefer to dose it in the evening as it is a viscous drop and I prefer the analgesic effects of the NSAID to last more during sleep so the patient has less risk of development of keratitis.
In fact, I have been so impressed by its efficacy that I’ve now paired it with Durezol in a Durezol qAM/Ilevro qhs fashion x 4 weeks. The results have been excellent, and patients have been thrilled with the dosing simplicity. While some changes in pharmaceutical products do not necessarily change the way we treat disease, for me this innovation has completely changed my post-op cataract regimen.