Eyeworld

by Title Contact Name: email Heading Name title APRIL 2022 | EYEWORLD | 3 by Eric Donnenfeld, MD Chief Medical Editor I always arrive at the ASCRS Annual Meeting excited about the new tech- nologies, mesmerized by the quality of education, and more passionate than ever about being an ophthalmologist. In this issue of EyeWorld, the official mem- ber publication of ASCRS, we highlight multiple areas of interest, including a number of sessions to be presented at the Annual Meeting that should not be missed. This issue of EyeWorld also has the true experts in the field educating us on diverse and important topics such as comanagement, IOL power misses, unhappy patients after cataract surgery, eye rubbing, how refractive procedures impact future implant choice, cyclodialysis clefts, SLT, pediatric MGD, varenicline, rosacea, and more. This is quite a diverse col- lection of topics to read about. I think one of the most important topics in this issue is the subject of keratoconus. I would like to take a moment to write about the quiet advances in keratoconus manage- ment that have taken place over the last 2 decades. The diagnosis, prevention, and treatment of keratoconus is a testimonial to innovation and meeting unmet needs. As a corneal specialist, I have helplessly watched from the safety of my slit lamp as thousands of patients develop ker- atoconus and slowly progress from glasses to rigid contact lenses then on to corneal transplantation. These patients are generally young, in their teens and early 20s, and they become visually handicapped while I sit by unable to intervene as corneas continue to steepen. Every year, I try to salvage the ruptured globe of a young patient who ex- perienced ocular trauma months, years, and even decades following a penetrating keratoplasty for keratoconus. The incidence of keratoconus is becoming epidem- ic. We are now aware that keratoconus induced by eye rubbing, often associated with obesity and sleep apnea, is increasing dramatically. The latest estimates suggest that 1 in 200 of our patients have keratoconus. A decade ago, in 2012, 7,405 Americans required a penetrating or lamellar keratoplasty for keratoconus. In 2019, this number decreased to 2,737. What is responsible for this remarkable decrease in keratoplasty for keratoconus while the incidence is increasing? I think that it is multifactorial. First of all, we are better able to diagnose the disease with improved diagnostic tests such as topography, tomography, Advances in keratoconus management 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 on page 10

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