Eyeworld

3 EW NEWS & OPINION by Lauren Lipuma EyeWorld Staff Writer AAO 2015 challenges attendees to immerse, connect, and get inspired September 2015 (SEI), David Geffen School of Med- icine, University of California, Los Angeles (UCLA), and is a professor of Meeting will focus on new research, technology, and thought-provoking discussions T he 2015 American Acad- emy of Ophthalmology (AAO) annual meeting will take place from November 14–17 at the Sands Expo/ Venetian in Las Vegas. This meet- ing, the AAO's 119th, has a packed program featuring more than 40 symposia, 30 skills transfer labs, 20 special sessions, and 200 instruction courses. Subspecialty day highlights Subspecialty days will take place on Friday, November 13 and Saturday, November 14. This year, attendees will be able to choose from 6 subspecialty fields: glaucoma, cornea, retina, refractive surgery, pediatric ophthalmology and strabismus, and neuro-ophthalmolo- gy. Cornea Subspecialty Day, "Show Me the Evidence! Back to Basics and Beyond," will focus on managing corneal infections, the best strategies for treating dry eye, and instances where conflicting data have created controversies in the field of cornea. Neuro-Ophthalmology Subspe- cialty Day, held every other year, returns to AAO in 2015 with a focus on "Neuro-Ophthalmology Made Ridiculously Simple." Speakers will provide pearls for easy diagnosis and treatment of vision loss, eye pain, headaches, double vision, and nystagmus. For the first time, Refractive Surgery Subspecialty Day, the annual meeting of the International Society of Refractive Surgery (ISRS), will be condensed into 1 day on Friday, November 13. Speakers will high- light new diagnostics in refractive surgery, discuss cornea- and lens- based procedures, present interactive doctor-patient consultations, and more. Opening session The AAO opening general session will take place on Sunday, Novem- ber 15, from 8:30–10:00 a.m. During the session, attendees will be able to hear from AAO leadership, celebrate ophthalmologists on the forefront of the field, and gain insights into the world visions of two past American leaders. Anne Louise Coleman, MD, Los Angeles, will deliver this year's Jackson Memorial Lecture, "How Big Data Informs Us About Cataract Surgery." Dr. Coleman serves as the Fran and Ray Stark professor of oph- thalmology at the Stein Eye Institute BRIEF SUMMARY PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7%. For topical ophthalmic administration. The following is a brief summary only; see full prescribing information for complete product information. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Contamination of Tip and Solution As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle to prevent contaminating the tip and solution. Keep bottle tightly closed when not in use. Contact Lens Use Patients should not wear a contact lens if their eye is red. The preservative in PAZEO solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least five minutes after instilling PAZEO before they insert their contact lenses. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. In a randomized, double-masked, vehicle-controlled trial, patients at risk for developing allergic conjunctivitis received one drop of either PAZEO (N=330) or vehicle (N=169) in both eyes for 6 weeks. The mean age of the population was 32 years (range 2 to 74 years). Thirty-five percent were male. Fifty-three percent had brown iris color and 23% had blue iris color. The most commonly reported adverse reactions occurred in 2-5% of patients treated with either PAZEO or vehicle. These events were blurred vision, dry eye, superficial punctate keratitis, dysgeusia and abnormal sensation in eye. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are no adequate or well-controlled studies with PAZEO in pregnant women. Olopatadine caused maternal toxicity and embryofetal toxicity in rats at levels 1,080 to 14,400 times the maximum recommended human ophthalmic dose (MRHOD). There was no toxicity in rat offspring at exposures estimated to be 45 to 150 times that at MRHOD. Olopatadine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data In a rabbit embryofetal study, rabbits treated orally at 400 mg/kg/day during organogenesis showed a decrease in live fetuses. This dose is 14,400 times the MRHOD, on a mg/m 2 basis. An oral dose of 600 mg/kg/day olopatadine (10,800 times the MRHOD) was shown to be maternally toxic in rats, producing death and reduced maternal body weight gain. When administered to rats throughout organogenesis, olopatadine produced cleft palate at 60 mg/kg/day (1080 times the MRHOD) and decreased embryofetal viability and reduced fetal weight in rats at 600 mg/kg/day. When administered to rats during late gestation and throughout the lactation period, olopatadine produced decreased neonatal survival at 60 mg/kg/day and reduced body weight gain in offspring at 4 mg/kg/day. A dose of 2 mg/kg/day olopatadine produced no toxicity in rat offspring. An oral dose of 1 mg/kg olopatadine in rats resulted in a range of systemic plasma area under the curve (AUC) levels that were 45 to 150 times higher than the observed human exposure [9.7 ng∙hr/mL] following administration of the recommended human ophthalmic dose. Nursing Mothers Olopatadine has been identified in the milk of nursing rats following oral administration. Oral administration of olopatadine doses at or above 4 mg/kg/day throughout the lactation period produced decreased body weight gain in rat offspring; a dose of 2 mg/kg/day olopatadine produced no toxicity. An oral dose of 1 mg/kg olopatadine in rats resulted in a range of systemic plasma area under the curve (AUC) levels that were 45 to 150 times higher than the observed human exposure [9.7 ng∙hr/mL] following administration of the recommended human ophthalmic dose. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when PAZEO is administered to a nursing mother. Pediatric Use The safety and effectiveness of PAZEO have been established in pediatric patients two years of age and older. Use of PAZEO in these pediatric patients is supported by evidence from adequate and well-controlled studies of PAZEO in adults and an adequate and well controlled study evaluating the safety of PAZEO in pediatric and adult patients. Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Olopatadine administered orally was not carcinogenic in mice and rats in doses up to 500 mg/kg/day and 200 mg/kg/day, respectively. Based on a 35 μL drop size and a 60 kg person, these doses are approximately 4,500 and 3,600 times the MRHOD, on a mg/m 2 basis. Mutagenesis No mutagenic potential was observed when olopatadine was tested in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian chromosome aberration assay or an in vivo mouse micronucleus test. Impairment of fertility Olopatadine administered at an oral dose of 400 mg/kg/day (approximately 7,200 times the MRHOD) produced toxicity in male and female rats, and resulted in a decrease in the fertility index and reduced implantation rate. No effects on reproductive function were observed at 50 mg/kg/day (approximately 900 times the MRHOD). PATIENT COUNSELING INFORMATION • Risk of Contamination: Advise patients to not touch dropper tip to eyelids or surrounding areas, as this may contaminate the dropper tip and ophthalmic solution. • Concomitant Use of Contact Lenses: Advise patients not to wear contact lenses if their eyes are red. Advise patients that PAZEO should not be used to treat contact lens-related irritation. Advise patients to remove contact lenses prior to instillation of PAZEO. The preservative in PAZEO solution, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted 5 minutes following administration of PAZEO. Patents: 8,791,154 ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA © 2015 Novartis. 6/15 PAZ15093JAD continued on page 10

• Cover