Eyeworld

by Title Heading Name title Contact Name: email ATARACT C 30 | EYEWORLD | SUMMER 2025 BRIEF SUMMARY: Please see the DEXTENZA Package Insert for full prescribing information (10/2021) 1 INDICATIONS AND USAGE 1.1 Ocular Inflammation and Pain Following Ophthalmic Surgery DEXTENZA ® (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery (1.1). 1.2 Itching Associated with Allergic Conjunctivitis DEXTENZA ® (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular itching associated with allergic conjunctivitis (1.2). 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. 5.6 Other Potential Corticosteroid Complications The initial prescription and renewal of the medication order of DEXTENZA should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. 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)]. 6.2 Ocular Inflammation and Pain Following Ophthalmic Surgery DEXTENZA safety 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%). 6.3 Itching Associated with Allergic Conjunctivitis DEXTENZA safety was studied in four randomized, vehicle-controlled studies (n= 154). The mean age of the population was 41 years (range 19 to 69 years), 55% were female and 61% were white. Fifty seven percent had brown iris color and 20% had blue iris color. The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: intraocular pressure increased (3%), lacrimation increased (1%), eye discharge (1%), and visual acuity reduced (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 eye care professional if pain, redness, or itching develops. Ocular Therapeutix, Inc. Bedford, MA 01730 USA PP-US-DX-0360 continued from page 28 in their 20s, particularly if it will be a longer case with iris manipulation, just to make sure they're comfortable. Dr. Larochelle noted that she utilizes several tools in these cases, like staining with trypan blue and using a Malyugin ring or iris hooks to help with small pupils. Sometimes you must surgically remove a pupillary mem- brane using intraoperative scissors or micro-scissors. In terms of lens considerations, Dr. Larochelle said she will try to use a single-piece acrylic lens in the bag. "I don't use multifocal lenses in patients with uveitis," she said. "I try to avoid those in patients with a history of uveitis be- cause I think they're going to have more issues with glare and halo." She will still use toric IOLs, however. As far as the Light Adjustable Lens (RxSight), Dr. Larochelle said, "the jury is still out on if it would be appropriate for patients with uveitis." These lenses are silicone, so there's some concern if they end up having a retinal detachment and need oil in the eye, she said. Historically, physicians would leave patients with uveitis aphakic after cataract surgery. "The data has shown that as long as the patient is well controlled as far as inflammation, we can put a lens in the eye at the time of cataract surgery without major complications." Some cases where Dr. Larochelle might still leave a patient aphakic would be someone with hypotony, if they have ciliary body atrophy or membrane and are hypotonus before cataract surgery. Dr. Galor said you might not want to get too fancy with your lens choices. Even when the uveitis is well controlled prior to surgery, inflammation may be more intense and/or persistent after surgery. A monofocal lens is generally the safest bet because these eyes are unpredictable. Postop considerations It's also possible to develop uveitis for the first time after cataract surgery, Dr. Galor said. In these cases, you need to figure out why there's inflammation, which could be caused by a number of factors. You need to think about an infection and always consider endophthalmitis, Dr. Galor said. Careful attention should be paid to the vitreous for the presence of cells, the anterior chamber for fibrin, and the lens capsule for depos- its—each of which can be indicative of endophthalmitis. Pigmented cells and keratic precipitates along with den- dritiform and geographic epithelial defects can be signs of new onset herpes infection after cataract surgery. You first want to make sure you're not missing an infection, whether it's bacterial or viral. Then, you need to ensure that the lens is not the problem. The problem can be with the "old" lens, such as a piece of retained nucleus hiding in the angle. Or it can be a

• Cover