Eyeworld Daily News

EW SHOW DAILY 22 ASCRS Symposia Tuesday, May 9, 2017 by Liz Hillman EyeWorld Staff Writer ASCRS, APACRS instructors share pearls at the inaugural TOPGUN symposium for her daring capsular tension ring (CTR) insertion. Her pearls included inserting the CTR toward the zone of zonular dialysis; using pupil ex- panders and dilating the pupil to get Maintaining the chamber, lens explantation, and capsulorhexis marking among the tips J ust an hour south of Los Angeles in Miramar, California, is the famous TOPGUN flight school, popularized by the 1986 film Top Gun. Instructors from both ASCRS and APACRS sought to bring the spirit of TOPGUN to a Sunday afternoon symposium. David Chang, MD, Los Altos, California, introduced this first-time symposium. "Only the most promis- ing Navy pilots attend the TOPGUN flight school … trained there by the Navy's best TOPGUN instructors to become elite fighter pilots," Dr. Chang said. In this session, "it's you who will be trained by TOPGUN phaco instructors to become elite cataract surgeons." While fighter pilots are taught complex flight maneuvers, however, the ASCRS and APACRS TOPGUN instructors were asked to present "simple trade secrets that make their cases look effortless and smooth," Dr. Chang said. In flight suits, hats, and aviator glasses, 14 instructors took to the stage to present their pearls. At the end of the symposium, the audience voted for winners in four catego- ries (spoiler alert: APACRS swept all four). The Great Balls of Fire award, presented by Steven "Legs" Schall- horn, MD, San Diego, a former real TOPGUN student and later instruc- tor, was given to Tetsuro "Samurai" Oshika, MD, PhD, Tsukuba, Japan, who presented his chamber mainte- nance technique called "goldfinger." "If the chamber collapses, extensive hydration may be need- ed. My tip is to put your goldfinger on the eye," Dr. Oshika said in his presentation. "When finished with I/A, just put your finger on the eye followed by injection of balanced salt solution." Dr. Oshika said that once the chamber collapses, wound chamber architecture can be compromised and restoration takes time. Putting your finger on the wound allows the wound architecture to be main- tained and the IOP increases. Graham Barrett, MD, Perth, Australia, a panelist in the session, called the idea "absolutely brilliant," but offered two other tips as well: Hydrate your incision before you take out your I/A and take it out quickly. The Danger Zone award was presented to Soosan "Blade Run- ner" Jacob, MD, Chennai, India, 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

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