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`Alcon Laboratories, Inc's Ilevro
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`Alcon Laboratories, Inc's Ilevro
`
`Jeff Prescott, PharmD, RPh, and Nicole Braccio, PharmD Candidate
`Published Online: Friday, May 17, 2013
`
`Ilevro (nepafenac ophthalmic suspension) is approved to reduce pain and inflammation resulting from
`cataract surgery.
`
`The FDA approved Alcon Laboratories, Inc’s, Ilevro (nepafenac ophthalmic suspension) 0.3% to reduce the
`pain and inflammation resulting from cataract surgery. The original approval took place in October 2012, but a
`labeling revision was made in December, and the official drug marketing launched in late January 2013. The
`lower strength nepafenac 0.1% is also available as branded Nevanac ophthalmic suspension and was
`approved by the FDA in 2005 for inflammation associated with cataract surgery.
`
`Pharmacology and Pharmacokinetics
`
`Ilevro is a topical nonsteroidal antiinflammatory prodrug that penetrates the cornea and is converted to a
`potent active metabolite, amfenac, by ocular hydrolases. Surgical trauma that occurs in ophthalmic surgery
`activates cyclooxygenase (COX) enzymes that yield prostaglandins, or inflammatory mediators. Both
`compounds are thought to inhibit COX enzymes, which results in inhibition of prostaglandin production. An
`advantage of Ilevro is its nonpolar structure, which allows effective corneal penetration to a greater extent than
`other NSAIDs. Ilevro’s rapid penetration minimizes contact time with the cornea, resulting in less corneal
`damage and fewer adverse effects. Peak concentration of Ilevro occurs between 30 and 45 minutes.
`Concentrations of Ilevro many times higher than therapeutic levels were not shown to affect CYP45
`metabolism; therefore, drug–drug interactions involving this pathway are unlikely.
`
`Dosage and Administration
`
`Ilevro is only available as a sterile ophthalmic suspension in a 1.7ml and 4ml bottle. Patients should shake
`well before use and instill 1 drop of Ilevro into the affected eye once daily starting 1 day before cataract
`surgery, on the day of surgery, and up to 2 weeks into the postoperative phase. It is also recommended to
`instill 1 drop into the affected eye at least 30 to 120 minutes prior to surgery. There are no drug interactions
`between Ilevro and other ophthalmic agents such as betablockers, carbonic anhydrase inhibitors, alpha
`agonists, cycloplegics, or mydriatics. However, if more than 1 agent is administered, they should be instilled at
`least 5 minutes apart to ensure adequate drug delivery.
`
`Clinical Trials
`
`A doubleblind randomized controlled trial assessed efficacy between nepafenac 0.3%, nepafenac 0.1%
`(Nevanac), and a nepafenac vehicle given 1 day prior to surgery, administered on the day of surgery, and
`continued into the first 2 weeks of the postoperative period. The primary outcome was clinical cure of
`inflammation at 14 days postoperative, defined as a score of 0, indicating no aqueous flares or aqueous cells
`were present. Other outcomes included clinical cure at 7 days postoperative and maintenance of clinical cure
`at 4 separate visits post–treatment cessation. Results concluded that inflammation and pain resolution were
`similar between Ilevro and Nevanac, but significantly improved between Ilevro and the vehicle alone. A second
`randomized controlled trial comparing only Ilevro and a vehicle confirmed these results. Ilevro was superior to
`the vehicle in resolving inflammation and pain at 7 and 14 days postsurgery. The benefit of Ilevro was
`demonstrated as early as 1 day postsurgery compared with vehicle. The patient was considered successful if
`they were declared cured and remained cured at subsequent visits. Additional clinical trials are ongoing to
`determine clinical significance in ocular surgeries other than cataract surgery.
`
`Contraindications, Warnings, and Precautions
`
`Ilevro is only contraindicated in patients with known hypersensitivity to any of its ingredients or other NSAIDs.
`The most serious adverse effects that may result from Ilevro are delayed healing, increased bleeding time, and
`keratitis or corneal inflammation. Contact lenses should not be worn while administering Ilevro. Serious
`
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`Alcon Laboratories, Inc's Ilevro
`3/14/2016
`damage can occur to the eyes if the bottle becomes contaminated, so taking measures to prevent
`contamination is essential (ie, avoid touching tip of dropper to eye). Ilevro has not been shown to cause
`teratogenic effects in rat and rabbit models; however, since no wellcontrolled studies have been performed in
`women, Ilevro is pregnancy category C but should be avoided in late pregnancy and in nursing women. Safety
`in pediatric patients aged under 10 years has not been established and there were no observed differences in
`the elderly population.
`
`Jeff Prescott, PharmD, RPh, is senior vice president of clinical and scientific affairs at Pharmacy Times. Nicole
`Braccio is a PharmD candidate at the Ernest Mario School of Pharmacy at Rutgers University.
`
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