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ASCRS NEWS PI 14 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 by Liz Hillman EyeWorld Senior Staff Writer A ttendees of the 2019 eyePAC reception were greeted by the sound of something they don't usually hear—the sound of monkeys. eyePAC reception gets wild at San Diego Zoo Donors to eyePAC and their guests enjoyed hors d'oeuvres in the San Diego Zoo's Sydney's Grill, which provided ambiance of the Australian outback. Live animal presentations featured an eagle owl, Virginia opossum, and more. Attendees were also able to see the zoo's koala and giraffe exhibits, which included a baby giraffe. "This reception is a way for ASCRS and eyePAC to say thank you to people who have contribut- ed. It's a fun event with excellent food and always an interesting venue," said Parag Parekh, MD, chair, ASCRS Government Rela- tions Committee, State College, Pennsylvania. "It's also a chance to hang out with like-minded people who are all interested in protecting our relationship with our patients and keeping insurance and the government at bay." The eyePAC reception, sponsored by the nonpartisan political action committee (PAC) of ASCRS, drew a crowd of more than 350. Nearly 100 donor attendees were ASCRS Young Eye Surgeon members, and several attendees brought their children as guests to this family-friendly venue. Surajit Saha, MD, Rock- ville Centre, New York, supports eyePAC to protect patients and the profession. "I think ophthalmic surgery is threatened by people who are not trained surgeons. … eyePAC's mission is to try to protect patients from suboptimal surgery. Surgery should only be by eye surgeons," Dr. Saha said. Even in social settings, Dr. Parekh said there are opportu- nities for physicians to share concerns and brainstorm ideas for better ways to deliver healthcare. "We help our pa- tients on a day-to-day, minute-to-minute basis, and why does that stop at 5 or 6 p.m.? I don't think it does. We are eye surgeons, and day and night we live and breathe this stuff," Dr. Parekh said. "ASCRS, the whole Government Relations [department], try to protect that doctor-patient relationship." Nick Mamalis, MD, a long-time eyePAC contributor and incoming ASCRS president, Salt Lake City, said that in helping facilitate advocacy for ophthalmol- ogists, eyePAC also advocates for patients. "eyePAC helps to support the ASCRS Government Relations Committee and its department, which is instrumental for allowing us to work with Congress and [regulatory agencies]," Dr. Mama- lis said. eyePAC is the collective voice of ophthalmic surgeons on Cap- itol Hill with eyePAC funds used to support federal candidates who support the issues important to ophthalmologists and serve on key committees with jurisdiction over healthcare policy. In addition to donating, there are other ways to get involved with government relations and advoca- cy, Dr. Parekh said. These include attending the Legislative Fly-Ins in Washington, D.C. or reaching out to your senator or congressman individually. "Getting to know your own representative is important be- cause building a relationship with someone is something that really helps in terms of advocacy," Dr. Mamalis said. Parag Parekh, MD, chair, ASCRS Government Relations Committee

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