Eyeworld

by Title Heading Name title Contact Name: email A SCRS Grand Rounds, a monthly CME opportu- nity, is hosted in partnership with major aca- demic institutions and features two challenging cases with panel discussions. The following is a recap of the latest cases presented in the series. For more on how these cases were diagnosed and treated, watch the full videos at ascrs.org/clinical- education/grand-rounds. Gavin Herbert Eye Institute, University of California, Irvine Case 1: Catherine Sheils, MD, PGY-3, discussed a case involving a patient with high expectations. The patient was a 67-year-old female with narrow angles who had laser pe- ripheral iridotomies in both eyes. In a cataract evaluation she said she couldn't watch TV, drive, or read and stated that even with glasses, which she said she couldn't tolerate, she couldn't see. Her vision in the right eye was 20/60-2 and 20/50 in the left. Dr. Sheils said there was no improve- ment in visual acuity with a manifest refraction or with her glasses. Anterior segment and fundus exams were normal and her cataract was graded as a 2+ NS. Tomography revealed more astigmatism in the right eye than what was recorded by the IOLMaster (Carl Zeiss Meditec). Case 2: Aman Mittal, MD, cornea and refractive surgery fellow, shared a case of a 59-year-old patient who pre- sented for a baseline assessment before starting a new medication that could worsen dry eye. He denied baseline symptoms of dry eye and his vision was stable since his last exam 8 years prior. Medical history included multiple myeloma, and he had strabismus that was treated with sur- gery. His manifest refraction was myopic. Slit lamp exam- ination showed mild MGD in both eyes with no evidence of dry eye. He was advised to start warm compresses and to return to clinic 6 weeks after starting his new medication. Visual changes and corneal effects were observed after starting the new medication. Bascom Palmer Eye Institute Case 1: Masako Chen, MD, cornea and external diseases fellow, presented a case of a 36-year-old male with blurry vision (right eye more than the left) for 2 years. He had a history of Marfan's syndrome, congenital ptosis, entropion repair, and multiple eyelid surgeries. The right eye's BCVA was E at 1 foot. He had superior scleral show, a dense, central leukoma with extensive and deep neovasculariza- tion, and 3 mm of lagophthalmos. Anterior segment OCT revealed an irregular epithelium and subepithelial 26 | EYEWORLD | JULY 2021 ASCRS NEWS ASCRS Grand Rounds recap 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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