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2019 ASCRS•ASOA San Diego Daily Tuesday

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ASOA NEWS ASCRS ASOA ANNUAL MEETING by Stefanie Petrou-Binder, MD EyeWorld Contributing Writer R esilience is a vital char- acteristic for individuals in leadership positions. Certified ophthalmic executives (COE) convened on Monday for an innovative lunch presentation on maintaining a culture of resilience at the work place, given by keynote speaker, Kevin Nourse, Palm Springs, California, an executive coach, author, organizational develop- ment consultant, and speaker with more than 20 years of experience developing resilient change leaders in the healthcare sector. He told attendees that ophthalmic execu- tives help to shape their practice and contribute strongly to creat- ing a culture of resilience among their team. Today's work place sets a greater burden for managers and leaders to model behavior. A thriving business needs more than functional knowledge and intelli- gence. Resilience is the process of adapting well in the face of adver- sity, bouncing back from difficult experiences. While some of us will succumb to adversity or survive with impairment when coping with setbacks, others will derive strength, recover, and hopefully thrive, grow, and transform. Mr. Nourse highlighted the importance of reflecting on sig- nificant challenges that made you stronger in your career as a place to gather strength and thrive in the face of adversity. Resiliency strate- gies include strengthening support networks, clarifying your purpose, building self-awareness, enhancing self-care, articulating strengths, and broadening your coping skills. Attendees agreed that seeing the silver lining in situations, having key people to talk to, and paying attention to their physical health (sleep, diet, exercise) all buffeted their resilience in weak moments. Mr. Nourse advised that COEs take a resilience self-assessment that asks questions such as: Which three people can I call for help? Do I know my emotional trig- gers? Do I take good physical care of myself ? Do I maximize the positive aspects of a challenge? Support networks not only tell you what you are doing right, but they also should let you know what you might be doing wrong. Support groups also model behavior and often send non-verbal, reinforc- ing messages through actions and attitudes. To strengthen your support network, Mr. Nourse suggests assessing the visibility of your pro- fessional network and finding an engaging mentor. A leader's purpose needs to be identified, inspire hope, and sus- tain resilience. It is vital to recog- nize that losing a battle is one side of the progress you are making overall on your career trajectory. He thinks that reflecting on peak experiences that identify your core values help to clarify purpose and keep you centered. We should all try to live two of our core values each day. This involves building self-awareness, for which he likes to keep a professional journal and suggests asking three trusted col- leagues for feedback. We all have blind spots and often a 360-degree assessment helps us realize what they are. Feedback helps good leaders stay on track, as does being good to yourself. If we don't sleep, everything we do suffers. Attendees who practiced meditation thought it helped them relax and allowed them to better cope with stress. Transparency and grace expose your best self and help to create a culture of resilience, he said. Resilience was the word of the day at the COE Lunch BRIEF SUMMARY: Please see the DEXTENZA Package Insert for full prescribing information for DEXTENZA (11/2018) 1 INDICATIONS AND USAGE DEXTENZA ® (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular pain following ophthalmic surgery (1). 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 three randomized, vehicle-controlled studies (n = 351). The mean age of the population was 68 years (range 43 to 87 years), 62% were female, and 85% were white. Forty-six percent had brown iris color and 31% 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 (9%); intraocular pressure increased (5%); visual acuity reduced (2%); eye pain (1%); cystoid macular edema (1%); corneal edema (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 LIVE EYEWORLDLIVE.COM

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