Eyeworld

EW NEWS & OPINION 16 The second option, and my pre- ferred approach, is to do a posterior capsular rhexis and to reverse cap- ture the optic—while this compro- mises the posterior capsule, one can perform a PCCC without disrupting vitreous. The only other considera- tion would be a refractive change of about –0.5 D, which if anything will give the patient a bit of mini-mono- vision in the weaker eye. Also, if one were to have access to an ECP probe, it would be great to use to evaluate for the presence of any aberrant interactions between the iris and other structures. Finally, no matter which procedure was performed, I would try to vigorously irrigate the TM with an I/A probe or cannula to attempt to debulk the TM of its pigment burden." "With respect to glaucoma, if the IOP was lower or the optic neu- ropathy was not as advanced, I would probably stop with the IOL surgery and give time for the TM to clear the pigment, but that luxury does not exist here and a combined procedure is necessary. A traditional trabeculectomy or tube shunt are reasonable options; however, there are some other options that avail themselves that would be preferred in my mind. My preferred filtering procedure is a deep sclerectomy with collagen implant; this confers com- parable IOP lowering with a superior safety profile and faster recovery. The other option is to do a MIGS procedure. While this would be con- sidered off-label use, the point of outflow resistance is at the level of the TM—an iStent [Glaukos, Laguna Hills, Calif.] overcomes this. Given that this patient has minimal field loss at this time, [the patient is] a great candidate to undergo iStent implantation." What was done As Mark and Baseer have suggested, I felt that there was possibly a com- ponent of reverse pupillary block (RPB) at play here, and the first thing I did was a laser iridotomy to eliminate that. All of the cases of pseudophakic RPB that I have seen have been in myopic patients with sulcus-placed lenses, and that was clearly the situation here. After the iridotomy, the patient's IOP did drop to 17 over the following month, but he was still on maximal medication, and I felt that something needed to be done to stop the iris chafing. I next took the patient to the operating room and did a combined trabecular aspiration of pigment (using a retina extrusion cannula under direct visualization of the angle), and this was combined with a reopening of the capsular bag and repositioning of the IOL within the capsular bag. One week after surgery the IOP was in the teens and the implant was well positioned within the bag. The patient did well for a few weeks, but he came in 1 month postop reporting glare and decreased vision. When he was dilated, it was clear that the IOL had rotated and shifted within the capsular bag. At this point, a decision was made to perform a second surgery to remove this IOL from the capsular bag and place a STAAR AQ2010V IOL in the sulcus and suture one haptic to sclera to prevent rotation or movement of the lens. This was successfully performed without need for vitrectomy and the patient has done very well since with 20/20 uncorrected vision and IOP in the teens on a single topical medication, timolol 0.5%. EW Contact information Gorovoy: mgorovoy@gorovoyeye.com Khan: baseer.khan@mac.com Pyfer: mfpyfer@gmail.com Safran: safran12@comcast.net May 2014 BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE ILEVRO™ Suspension is indicated for the treatment of pain and inammation associated with cataract surgery. DOSAGE AND ADMINISTRATION Recommended Dosing One drop of ILEVRO™ Suspension should be applied to the aected eye one-time-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the rst 2 weeks of the postoperative period. An additional drop should be administered 30 to 120 minutes prior to surgery. Use with Other Topical Ophthalmic Medications ILEVRO™ Suspension may be administered in conjunction with other topical ophthalmic medications such as beta-blockers, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics. If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. CONTRAINDICATIONS ILEVRO™ Suspension is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other NSAIDs. WARNINGS AND PRECAUTIONS Increased Bleeding Time With some nonsteroidal anti-inammatory drugs including ILEVRO™ Suspension, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that ILEVRO™ Suspension be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Delayed Healing Topical nonsteroidal anti-inammatory drugs (NSAIDs) including ILEVRO™ Suspension, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Corneal Eects Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs including ILEVRO™ Suspension and should be closely monitored for corneal health. Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post surgery may increase patient risk and severity of corneal adverse events. Contact Lens Wear ILEVRO™ Suspension should not be administered while using contact lenses. ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reect the rates observed in practice. Ocular Adverse Reactions The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These events occurred in approximately 5 to 10% of patients. Other ocular adverse reactions occurring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment. Some of these events may be the consequence of the cataract surgical procedure. Non‐Ocular Adverse Reactions Non‐ocular adverse reactions reported at an incidence of 1 to 4% included headache, hypertension, nausea/vomiting, and sinusitis. USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Eects. Pregnancy Category C: Reproduction studies performed with nepafenac in rabbits and rats at oral doses up to 10 mg/kg/day have revealed no evidence of teratogenicity due to nepafenac, despite the induction of maternal toxicity. At this dose, the animal plasma exposure to nepafenac and amfenac was approximately 70 and 630 times human plasma exposure at the recommended human topical ophthalmic dose for rats and 20 and 180 times human plasma exposure for rabbits, respectively. In rats, maternally toxic doses ≥10 mg/kg were associated with dystocia, increased postimplantation loss, reduced fetal weights and growth, and reduced fetal survival. Nepafenac has been shown to cross the placental barrier in rats. There are no adequate and well‐controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ILEVRO™ Suspension should be used during pregnancy only if the potential benet justies the potential risk to the fetus. Non‐teratogenic Eects. Because of the known eects of prostaglandin biosynthesis inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ILEVRO™ Suspension during late pregnancy should be avoided. Nursing Mothers ILEVRO™ Suspension is excreted in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ILEVRO™ Suspension is administered to a nursing woman. Pediatric Use The safety and eectiveness of ILEVRO™ Suspension in pediatric patients below the age of 10 years have not been established. Geriatric Use No overall dierences in safety and eectiveness have been observed between elderly and younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Nepafenac has not been evaluated in long‐term carcinogenicity studies. Increased chromosomal aberrations were observed in Chinese hamster ovary cells exposed in vitro to nepafenac suspension. Nepafenac was not mutagenic in the Ames assay or in the mouse lymphoma forward mutation assay. Oral doses up to 5,000 mg/kg did not result in an increase in the formation of micronucleated polychromatic erythrocytes in vivo in the mouse micronucleus assay in the bone marrow of mice. Nepafenac did not impair fertility when administered orally to male and female rats at 3 mg/kg. PATIENT COUNSELING INFORMATION Slow or Delayed Healing Patients should be informed of the possibility that slow or delayed healing may occur while using nonsteroidal anti‐inammatory drugs (NSAIDs). Avoiding Contamination of the Product Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery. Contact Lens Wear ILEVRO™ Suspension should not be administered while wearing contact lenses. Intercurrent Ocular Conditions Patients should be advised that if they develop an intercurrent ocular condition (e.g., trauma, or infection) or have ocular surgery, they should immediately seek their physician's advice concerning the continued use of the multi‐dose container. Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. Shake Well Before Use Patients should be instructed to shake well before each use. U.S. Patent Nos. 5,475,034; 6,403,609; and 7,169,767. ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA © 2013 Novartis 2/13 ILV13030JAD Rubbin' continued from page 14

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