Eyeworld Daily News

EW SHOW DAILY 16 Wednesday, May 10, 2017 by Ellen Stodola EyeWorld Senior Staff Writer Corneal ectasia discussed in symposium conditions that can make contact lens fitting difficult. She detailed the variety of con- tact lens options that are available. The first was rigid gas permeable Jessica Ciralsky, MD, New York, spoke about contact lens options for keratoconus. Ectatic disorders come in many shapes and sizes, she said, and many times, there are coexisting the fellow eye is, if the astigmatism is reproducible across devices and is somewhat regular, and if there is any consideration for multifocal or EDF lenses. A Monday afternoon sym- posium sponsored by the Contact Lens Association of Ophthalmologists (CLAO) highlighted the topic of corneal ectasia. The session featured the Richard L. Lindstrom, MD Lecture given by Samuel Mas- ket, MD, Los Angeles, on "Cataract Surgery in the Presence of the Ab- normal Cornea." In his lecture, Dr. Masket spoke about stromal disease, the post-re- fractive cornea, surface disorders, endothelial disease, and corneal shape abnormalities. First, he discussed stromal dis- ease, which could include opacities, scars, irregular astigmatism, and viral disease. Visibility is often a problem at surgery, he said. Remov- ing the epithelium is key because once you do that, you can increase visibility. If a patient has viral disease, Dr. Masket said he will use oral antivirals. He also said to stage the surgery if possible for IOL power calculation post-PKP. Post refractive corneas are very common, and these may be inci- sional or laser-ablated procedures, he said. Physicians have to look schematically at what they do to the cornea when they do these procedures to get an idea of how to overcome the issues. Next, Dr. Masket spoke about surface disorders, specifically dry eye disease, epithelial basement mem- brane dystrophy (EBMD), pterygi- um, and stem cell failure. Dry eye disease could be impacted by the climate in which you work, he said. EBMD is often overlooked; physi- cians could miss significant irregular astigmatism due to it. Topography is essential, he said. With endothelial disease, Dr. Masket said to be as protective as you can be. He thinks the femtosec- ond laser is particularly helpful in cases of compromised endothelium, shallow anterior chamber, dense cataract, zonulopathy, and capsule issues. Finally, Dr. Masket highlight- ed corneal shape abnormalities, particularly surgical challenges with keratoconus. It's all about IOL selec- tion, he said, because the surgery is mostly routine. Things to consider are if the patient is contact lens de- pendent and tolerant, if the cornea is stable, what the optical status of 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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