Eyeworld

3 by Rich Daly EyeWorld Contributing Writer EW ASCRS NEWS Inaugural Steinert Refractive Lecture: Posterior cornea is missing key in refractive outcomes June 2017 "That's why we can't use ante- rior corneal measurements in those patients," Dr. Koch said. In the Steinert Refractive Lecture, Douglas Koch, MD, examined the challenges of IOL calculations in postop and ectatic corneas W hat's preventing great- er predictability from IOL calculations? A key limitation that Douglas Koch, MD, professor and the Allen, Mosbacher, and Law chair, Cullen Eye Insti- tute, Baylor College of Medicine, Houston, sees is the continued use of assumptions regarding posterior corneal power. "In our biometric measure- ments, we're much more accurate with some parameters that used to be a problem," Dr. Koch said in the first Steinert Refractive Lecture during Refractive Day at the 2017 ASCRS•ASOA Symposium & Con- gress. "But the cornea continues to be a challenge—both anterior and posterior." Despite numerous tools to measure the anterior cornea, varia- tion from predicted outcomes has continued among a large segment of patients. Dr. Koch concluded that such variation is not due to the mea- surement devices but to the condi- tions of the cornea and the tear film when measured. "Why all this variability? We know it's tear film, it's corneal con- dition, it's user ability, and it's our understanding of corneal topogra- phy, refractive power, and which zones are important in refraction," Dr. Koch said. In addition, reaching the goal of exceeding 90% of refractive outcomes within +/–0.5 D of the intended outcome will likely require factoring in the posterior cornea. The current approach to in- cluding posterior curvature entails measuring the anterior cornea in very limited zones, extrapolating posterior corneal curvature using a population average of the ratio of the posterior to the anterior, and calculating total corneal power. Using Scheimpflug photogra- phy, Dubbelman et al. calculated a mean ratio between anterior and posterior corneal surfaces of 0.81.¹ Dr. Koch's studies using the Galilei Dual Scheimpflug Analyzer (Ziemer Ophthalmic Systems, Port, Switzer- land) and color LED devices found similar values for normal eyes, but slightly lower values for myopic LASIK and photorefractive keratecto- my (PRK) corneas, and slightly high- er for hyperopic LASIK/PRK corneas. 2 continued on page 8 DUREZOL® (difuprednate ophthalmic emulsion) 0.05% Initial U.S. approval: 2008 Brief Summary: Please see package insert for full prescribing information. 1 INDICATIONS AND USAGE 1.1 Ocular Surgery DUREZOL ® (difluprednate ophthalmic emulsion) 0.05%, a topical cortico - steroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis DUREZOL is also indicated for the treatment of endogenous anterior uveitis. 4 CONTRAINDICATIONS The use of DUREZOL, as with other ophthalmic corticosteroids, is contra - indicated in most active viral diseases of the cornea and conjunctiva includ- ing epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. 5 WARNINGS AND PRECAUTIONS 5.1 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. 5.2 Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation. 5.3 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 top- ical steroids. The initial prescription and renewal of the medication order beyond 28 days 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. 5.4 Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent condi- tions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. 5.5 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 infec- tions of the eye (including herpes simplex). 5.6 Fungal Infections Fungal infections of the cornea are particularly prone to develop coinciden- tally with long-term local steroid application. Fungus invasion must be con- sidered in any persis tent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate. 5.7 Topical Ophthalmic Use Only DUREZOL is not indicated for intraocular administration. 5.8 Contact Lens Wear DUREZOL should not be instilled while wearing contact lenses. Remove con- tact lenses prior to instillation of DUREZOL. The preservative in DUREZOL may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of DUREZOL. 6 ADVERSE REACTIONS The following serious reactions are found elsewhere in the labeling: • Elevated intraocular pressure [see Warnings and Precautions (5.1)] • Posterior subcapsular cataract formation [see Warnings and Precautions (5.2)] • Secondary ocular infection [see Warnings and Precautions (5.4)] • Perforation of the globe [see Warnings and Precautions (5.3)] 6.1 Ocular Surgery Ocular adverse reactions occurring in 5-15% of subjects in clinical studies with DUREZOL included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Other ocular adverse reactions occurring in 1-5% of subjects included reduced visual acuity, punctate keratitis, eye inflammation, and iritis. Ocular adverse reac- tions occurring in < 1% of subjects included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macu- lar edema, sclera hyperemia, and uveitis. Most of these reactions may have been the consequence of the surgical procedure. 6.2 Endogenous Anterior Uveitis A total of 200 subjects participated in the clinical trials for endogenous ante- rior uveitis, of which 106 were exposed to DUREZOL. The most common adverse reactions of those exposed to DUREZOL occurring in 5-10% of sub- jects included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis. Adverse reactions occurring in 2-5% of subjects included anterior chamber flare, corneal edema, dry eye, iridocyclitis, photophobia, and reduced visual acuity. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects Pregnancy Category C. Difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered sub- cutaneously to rabbits during organogenesis at a dose of 1-10 mcg/kg/day. The no- observed-effect-level (NOEL) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered to be a teratogenic dose that was con- currently found in the toxic dose range for fetuses and pregnant females. Treatment of rats with 10 mcg/kg/day subcutaneously during organogenesis did not result in any reproductive toxicity, nor was it maternally toxic. At 100 mcg/kg/day after subcutaneous administration in rats, there was a decrease in fetal weights and delay in ossification, and effects on weight gain in the pregnant females. It is difficult to extrapolate these doses of difluprednate to maximum daily human doses of DUREZOL, since DUREZOL is administered topically with minimal systemic absorption, and difluprednate blood levels were not measured in the reproductive animal studies. How- ever, since use of difluprednate during human pregnancy has not been eval- uated and cannot rule out the possibility of harm, DUREZOL should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus. 8.3 Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quanti- ties in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous cortico - steroid production, or cause other untoward effects. Caution should be exer- cised when DUREZOL is administered to a nursing woman. 8.4 Pediatric Use DUREZOL was evaluated in a 3-month, multicenter, double-masked trial in 79 pediatric patients (39 DUREZOL; 40 prednisolone acetate) 0 to 3 years of age for the treatment of inflammation following cataract surgery. A similar safety profile was observed in pediatric patients comparing DUREZOL to prednisolone acetate ophthalmic suspension, 1%. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients. U.S. Pat.: www.alconpatents.com © 2017 Novartis 4/17 DZL-1343556 Distributed by: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 USA 9013700 97820 DZL-1343556 EW.indd 2 5/24/17 10:09 AM

• Blank Page
• Blank Page (1)