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40 | EYEWORLD DAILY NEWS | MAY 17, 2020 DAILY NEWS ASCRS VIRTUAL ANNUAL MEETING useful for understanding the reason for a reduction in visual quality. The image simulation view is an ideal tool for showing patients the impact of elevated higher order aberrations. The point spread func- tion graphically illustrates the response of an optical system to a point source of light. This represents image degradation when passing through the optic of the lens. This is rarely used in clinical practice but is more of an advanced tool used by optical engineers. The presentation also offered more uses for Placido topography. Dr. Hill detailed how it might be used to eval- uate the ocular surface, for doing toric IOL calculations, and for validating measure- ments. The presentation went further in sharing a histor- ical perspective of optical aberrations to help provide understanding of anterior corneal aberrations. Dr. Hill mentioned other sources of vi- sual blurring/reduced contrast in the human eye that cannot be corrected with glasses, such as dispersion, diffraction, and scattering. Dr. Hill also shared infor- mation for IOL selection in those with prior LASIK/PRK and RK. For a more in-depth look at this topic and the informa- tion provided by Dr. Hill, view instruction course IC-4. Editors' note: Dr. Hill has financial interests with Alcon, Haag-Streit, Omega Ophthalmics, Optos, Carl Zeiss Digital Innovations, and LENSAR. reference in an attempt to eliminate toricity from the map display. It also displays eleva- tion differences that cannot be accounted for with a best fit toric reference. This map is similar to an elevation map, but the reference is a best fit toric surface rather than a best fit sphere surface. The rings image is a reflected contour map of the corneal surface, with contour lines that demonstrate areas of steepening and flattening. This provides a broad overview of the anterior corneal surface and is useful for keratoconus, corneal scarring, and prior refractive surgery. This map is based on sophisticated video- keratographic imaging. Simulated keratometry is a topographer simulating a stan- dard keratometer. This may not completely correlate with the magnitude and principal meridians of common auto- keratometry, especially for low astigmatism, but it's a useful screen for the identification of irregular and/or asymmetric astigmatism. This can also be helpful in contact lens fitting. The refractive power map displays the refractive power of the cornea based on Snell's law. This is useful for documenting pre- and post-refractive surgery corneal shaping and is often used to demonstrate uniformity within the pupil zone. It takes into ac- count spherical aberration and may show a direct correlation with overall visual quality. In terms of the corne- al wavefront view, Dr. Hill's presentation referenced the Zernike table, which provides quantitative representation of corneal aberrations and can be continued from page 38 BRIEF SUMMARY: Please see the DEXTENZA Package Insert for full prescribing information for DEXTENZA (06/2019) 1 INDICATIONS AND USAGE DEXTENZA ® (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery. 4 CONTRAINDICATIONS DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis. 5 WARNINGS AND PRECAUTIONS 5.1 Intraocular Pressure 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. Intraocular pressure should be monitored during the course of the treatment. 5.2 Bacterial Infection Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection [see Contraindications (4)]. 5.3 Viral Infections Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex) [see Contraindications (4)]. 5.4 Fungal Infections Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate [see Contraindications (4)]. 5.5 Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. 6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Intraocular Pressure Increase [see Warnings and Precautions (5.1)] • Bacterial Infection [see Warnings and Precautions (5.2)] • Viral Infection [see Warnings and Precautions (5.3)] • Fungal Infection [see Warnings and Precautions (5.4)] • Delayed Healing [see Warnings and Precautions (5.5)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation; delayed wound healing; secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera [see Warnings and Precautions (5)]. DEXTENZA was studied in four randomized, vehicle-controlled studies (n = 567). The mean age of the population was 68 years (range 35 to 87 years), 59% were female, and 83% were white. Forty-seven percent had brown iris color and 30% had blue iris color. The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%); intraocular pressure increased (6%); visual acuity reduced (2%); cystoid macular edema (1%); corneal edema (1%); eye pain (1%) and conjunctival hyperemia (1%). The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%). 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies with DEXTENZA in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, administration of topical ocular dexamethasone to pregnant mice and rabbits during organogenesis produced embryofetal lethality, cleft palate and multiple visceral malformations [see Animal Data]. Data Animal Data Topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in a mouse study. A daily dose of 0.75 mg/kg/day in the mouse is approximately 5 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m 2 basis. In a rabbit study, topical ocular administration of 0.1% dexamethasone throughout organogenesis (0.36 mg /day, on gestational day 6 followed by 0.24 mg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys. A daily dose of 0.24 mg/day is approximately 6 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m 2 basis. 8.2 Lactation Systemically administered corticosteroids appear in human milk and could suppress growth and interfere with endogenous corticosteroid production; however the systemic concentration of dexamethasone following administration of DEXTENZA is low [see Clinical Pharmacology (12.3)]. There is no information regarding the presence of DEXTENZA in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production to inform risk of DEXTENZA to an infant during lactation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DEXTENZA and any potential adverse effects on the breastfed child from DEXTENZA. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients. 17 PATIENT COUNSELING INFORMATION Advise patients to consult their surgeon if pain, redness, or itching develops. MANUFACTURED FOR: Ocular Therapeutix, Inc. Bedford, MA 01730 USA PP-US-DX-0072-V2

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