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48 | EYEWORLD DAILY NEWS | MAY 16, 2020 DAILY NEWS ASCRS VIRTUAL ANNUAL MEETING Being a leader in a time of crisis this is "how leaders should act all the time but even more so during a crisis." "Leaders will have every- thing to do with success as we come back out the other side," he said. Remain calm, create a task force Laura Baldwin said it is im- portant for physician business owners to "remain calm and be seen as someone who can and will lead the practice through these turbulent times." The first step is to get educated: about the situation, about the financial health and operations of the practice, and about programs and government stimulus that could offer aid. "This is more than one person can manage, so it is essential that a core team is assembled to assist with the many moving parts," Ms. Bald- win said. "Create a task force of essential team members that will be instrumental in helping to create and implement your plan. Engage with experienced and trusted advisors to ensure you are thinking about the right things. Deliver frequent, transparent, empathetic, and hopeful communication. Now more than ever, people need to hear from the physician leaders, and they need to know 'we've got this.'" Communicate often, acknowledge fear Ms. Baldwin said it is im- portant to acknowledge the uncertainty and stress employ- ees might have during this time. "People need to know a leader is connected to and appreciates the very real emo- tions that they feel," she said. by Liz Hillman Editorial Co-Director This article originally ran in the May issue of EyeWorld and high- lights how to be a leader in a time of crisis, featuring informa- tion from a March webinar from BSM Consulting. During the ASCRS Virtual Annual Meeting, Bruce Maller of BSM Consulting will be presenting and serving as a moderator of the "Turning the Lights Back On" special ses- sions, which will be streamed on Saturday, May 16 and Sunday, May 17 from 9:00–10:00 a.m. ET. Mr. Maller will again be sharing information on be- ing a leader in a time of crisis during the Saturday session. In the Sunday session, he will be presenting on sharpening a business plan and "refining and right sizing" your operational model. "Turning the Lights Back On" is a two-part comprehensive overview of what ophthalmol- ogists and their administrators should know about reopening their practices and caring for patients safely and effectively, with the leadership needed to make important changes in their business model. Specific rec- ommendations will provide the knowledge and resources needed to get back to work. O phthalmologists are being looked at for leadership now more than ever within their practices. But how to lead effectively in the midst of a pandemic affecting not just global health status but also the economy is a challenge. EyeWorld reached out to experts for their advice on how MDs can man the helm during this crisis with the novel coro- navirus known as SARS-CoV-2, which causes COVID-19. Bruce Maller said in a March webinar offered by BSM Consulting that 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 continued on page 50

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