EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/115557
March 2013 EW NEWS & OPINION 5 2ND ANNUAL ANNUAL This year the plan is to focus on refractive cataract surgery and minimally invasive glaucoma surgery (MIGS), Dr. Cunningham said. In addition to the two main topics, there will likely be some broader presentations. Dr. Kliman added that other topics might be presbyopia in refractive cataract surgery and the market that is opening up with the MIGS devices. He said there will be a combination of topics focused on clinicians and companies. "We'll have an FDA session and talk about some of [those] issues." "OIS@ASCRS, which is predominantly anterior segment and device focused, is intended to complement the focus of OIS@AAO, which is both drugs and devices within ophthalmology in general," Dr. Cunningham said. He said that some companies that will be highlighted at OIS@ASCRS are related to cataract refractive surgery and MIGS. He said these are likely to include LenSx (Alcon, Fort Worth, Texas) and OptiMedica (Sunnyvale, Calif.) in the femtosecond cataract surgery space, and Glaukos (Laguna Hills, Calif.) in the MIGS space, among others. Last year's meeting had close to 400 attendees, Dr. Cunningham said. "It's a great opportunity for clinicians who are interested in innovation and entrepreneurial processes to get exposed to the process," he said More information on OIS can be found at www.ophthalmologysummit.com. EW Editors' note: Dr. Cunningham is a partner at Clarus Ventures. Dr. Kliman is the managing director at InterWest Partners. Contact information Cunningham: ECunningham@clarusventures.com APRIL 18, 2013 18, 2013 The Westin, San Francisco Market Street Westin, Francisco Market Street Register now at www.OISASCRS.com USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Pregnancy Category C. 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 Brief Summary: Based on full prescribing information. 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 To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb at embryotoxicity (increased post-implantation losses at 100 mg/kg/day and 1-800-323-0000 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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) INDICATIONS AND USAGE during organogenesis did not result in any reproductive toxicity. Loteprednol LOTEMAX is a corticosteroid indicated for the treatment of post-operative etabonate was maternally toxic (significantly reduced body weight gain during inflammation and pain following ocular surgery. treatment) when administered to pregnant rats during organogenesis at doses DOSAGE AND ADMINISTRATION of ≥5 mg/kg/day. Invert closed bottle and shake once to fill tip before instilling drops. Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from Apply one to two drops of LOTEMAX into the conjunctival sac of the affected the start of the fetal period through the end of lactation, a maternally toxic eye four times daily beginning the day after surgery and continuing treatment regimen (significantly decreased body weight gain), gave rise to throughout the first 2 weeks of the post-operative period. decreased growth and survival, and retarded development in the offspring CONTRAINDICATIONS 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 LOTEMAX, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period. simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. There are no adequate and well controlled studies in pregnant women. LOTEMAX should be used during pregnancy only if the potential benefit WARNINGS AND PRECAUTIONS justifies the potential risk to the fetus. Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids may result in glaucoma with damage to the Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids 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 could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress days or longer, intraocular pressure should be monitored. growth, interfere with endogenous corticosteroid production, or cause other Cataracts untoward effects. Caution should be exercised when LOTEMAX is administered Use of corticosteroids may result in posterior subcapsular cataract formation. to a nursing woman. Delayed Healing Pediatric Use The use of steroids after cataract surgery may delay healing and increase the Safety and effectiveness in pediatric patients have not been established. incidence of bleb formation. In those diseases causing thinning of the cornea Geriatric Use or sclera, perforations have been known to occur with the use of topical No overall differences in safety and effectiveness have been observed steroids. The initial prescription and renewal of the medication order should between elderly and younger patients. be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, NONCLINICAL TOXICOLOGY fluorescein staining. Carcinogenesis, Mutagenesis, Impairment Of Fertility Bacterial Infections Long-term animal studies have not been conducted to evaluate the Prolonged use of corticosteroids may suppress the host response and carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was thus increase the hazard of secondary ocular infections. In acute purulent not genotoxic in vitro in the Ames test, the mouse lymphoma tk assay, or in conditions of the eye, steroids may mask infection or enhance existing a chromosome aberration test in human lymphocytes, or in vivo in the single infection. 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 Viral Infections Employment of a corticosteroid medication in the treatment of patients with and 300 times the maximum clinical dose, respectively) prior to and during a history of herpes simplex requires great caution. Use of ocular steroids may mating did not impair fertility in either gender. prolong the course and may exacerbate the severity of many viral infections PATIENT COUNSELING INFORMATION of the eye (including herpes simplex). Administration Fungal Infections Invert closed bottle and shake once to fill tip before instilling drops. Fungal infections of the cornea are particularly prone to develop coincidentally Risk of Contamination with long-term local steroid application. Fungus invasion must be considered Patients should be advised not to allow the dropper tip to touch any surface, in any persistent corneal ulceration where a steroid has been used or is in as this may contaminate the gel. use. Fungal cultures should be taken when appropriate. Contact Lens Wear Contact Lens Wear Patients should be advised not to wear contact lenses when using LOTEMAX. Patients should not wear contact lenses during their course of therapy with Risk of Secondary Infection LOTEMAX. If pain develops, redness, itching or inflammation becomes aggravated, the ADVERSE REACTIONS patient should be advised to consult a physician. Adverse reactions associated with ophthalmic steroids include elevated FOR MORE DETAILED INFORMATION, PLEASE READ THE PRESCRIBING intraocular pressure, which may be associated with infrequent optic nerve INFORMATION. damage, visual acuity and field defects, posterior subcapsular cataract Bausch & Lomb Incorporated formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there Tampa, Florida 33637 USA US Patent No. 5,800,807 is thinning of the cornea or sclera. ©Bausch & Lomb Incorporated The most common adverse drug reactions reported were anterior chamber ®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates. inflammation (5%), eye pain (2%), and foreign body sensation (2%). 9303400