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EW SHOW DAILY 22 ASCRS News Today Sunday, May 7, 2017 BRIEF SUMMARY OF PRESCRIBING INFORMATION This Brief Summary does not include all the information needed to information for Lotemax Gel. Lotemax (loteprednol etabonate ophthalmic gel) 0.5% Rx only Initial Rx Approval: 1998 INDICATIONS AND USAGE LOTEMAX is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. DOSAGE AND ADMINISTRATION Invert closed bottle and shake once to fill tip before instilling drops. Apply one to two drops of LOTEMAX into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. CONTRAINDICATIONS LOTEMAX, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. WARNINGS AND PRECAUTIONS Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored. Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation. Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Viral Infections Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungal Infections Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate. Contact Lens Wear Patients should not wear contact lenses during their course of therapy with LOTEMAX. ADVERSE REACTIONS Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. The most common adverse drug reactions reported were anterior chamber inflammation (5%), eye pain (2%), and foreign body sensation (2%). USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (6 times the maximum daily clinical dose). Oral treatment of rats during organogenesis resulted in teratogenicity (absent innominate artery at ≥5 mg/kg/day doses, and cleft palate and umbilical hernia at ≥50 mg/kg/day) and embryotoxicity (increased post-implantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥50 mg/kg/day). Treatment of rats with 0.5 mg/kg/day (6 times the maximum clinical dose) during organogenesis did not result in any reproductive toxicity. Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥5 mg/kg/day. Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival, and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period. There are no adequate and well controlled studies in pregnant women. LOTEMAX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when LOTEMAX is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment Of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma tk assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the single dose mouse micronucleus assay. Treatment of male and female rats with up to 50 mg/kg/day and 25 mg/kg/day of loteprednol etabonate, respectively, (600 and 300 times the maximum clinical dose, respectively) prior to and during mating did not impair fertility in either gender. PATIENT COUNSELING INFORMATION Administration Invert closed bottle and shake once to fill tip before instilling drops. Risk of Contamination Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the gel. Contact Lens Wear Patients should be advised not to wear contact lenses when using LOTEMAX. Risk of Secondary Infection If pain develops, redness, itching or inflammation becomes aggravated, the patient should be advised to consult a physician. LGX.0114.USA.16 Based on 9269101/9269201 Revised: 08/2016 Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA US Patent No. 5,800,807 ©Bausch & Lomb Incorporated Lotemax is a registered trademark of Bausch & Lomb Incorporated or its affiliates. prescribe Lotemax Gel safely and effectively. See full prescribing Carolyn Hebson, MD, Atlanta, attended the lab to ensure she was using the most up-to-date phaco techniques. She worked on the cre- ation of Hoffman pockets for scleral IOL fixation. "I was trying to do more suture techniques—fixing iris defects or lens dislocation situations—I've nev- er done one and now I feel like I can go do it," Dr. Hebson said. Dr. Hebson said the phaco lab is especially useful for surgeons with questions about areas with which they are struggling. "It's a perfect course for that," Dr. Hebson aid. Kevin Miller, MD, Los Ange- les, lead instructor for the session and its organizer for more than a decade, said it usually draws attend- ees aiming to learn advanced phaco techniques. "But we have a large enough umbrella that for almost anything they want to try, we've got the equipment and the expertise here," Dr. Miller said. The lab included phaco equip- ment from three companies—Cen- turion (Alcon, Fort Worth, Texas), Signature Pro (Johnson & Johnson Vision, Santa Ana, California), and Stellaris (Bausch + Lomb, Bridge- water, New Jersey)—plus a range of equipment from a total of about 25 companies, such as lens implants, pupil expansion rings, and devices for tying sutures. The lab is unique because it brings together the equip- ment of a range of manufacturers so attendees can quickly obtain broad experience. Although many ASCRS lab pro- grams have changed over the years, the phaco lab has remained consis- tent in helping surgeons stay current on the latest phaco equipment and techniques, Dr. Miller said. "The technology is always changing; there's always something new in cataract surgery so it is al- ways timely," Dr. Miller said. Other labs at ASCRS include ones focused on vitrectomy, iris su- turing, femtosecond lasers, and mi- croinvasive glaucoma surgery. Pos- sible future labs include an intraop refractive guidance lab, which could include the various manufacturers of technology that allow surgeons to orient lens implants and determine the power in the aphakic state. The lab that fills up fastest is the iris suturing lab. "It's something that you don't get to do very often so a lot of peo- ple like to brush up on their skills for that occasional patient," Dr. Miller said. The key to the appeal of the labs remains their volunteer instructors. "We have world-class faculty here, some of the very best cataract surgeons in the world sitting in this room instructing people who are learners," Dr. Miller said. "They get one-on-one instructions from lead- ing authorities, and you don't get that anywhere else." One of those instructors, Gerald Roper, MD, Batesville, Indiana, prac- tices in a small independent practice and enjoys the opportunity the labs provide to give back to his profes- sion and colleagues. "I enjoy teaching, but I am not in an environment where I have that much teaching or collegiality on a day-to-day basis, so I take time every year to provide the instruction because it's my giveback portion of this meeting," Dr. Roper said. EW Editors' note: Dr. Miller has finan- cial interests with Johnson & Johnson Vision and Alcon. Wet lab continued from page 19

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