Eyeworld

by Title Heading Name title Contact Name: email 34 | EYEWORLD | SEPTEMBER 2021 is equivalent to a 4K monitor at 1.5 meters, she said. She also explained that the user is able to control all functions, including focus, zoom, X-Y axis, intensity, and data menus with head gestures and voice controls. Advantages of such technology include unique attri- butes like panning, which enables working under high magnification while maintaining spatial orientation, en- hanced ergonomics, teaching and remote training capabili- ty, and a small footprint in the OR. Ayman Naseri, MD, presented on ForSight VISION6's Opira accommodating IOL, still in development. He gave an overview of why an accommodating IOL is needed and how Opira takes a different approach. He described Opira as a ciliary muscle-driven, capsule-fixated, dynamic, shape-changing IOL. He also showed research that found Opira was able to deliver high-quality monofocal-like dis- tance vision across the range of vision. Yoram Solberg, MD, PhD, described the Eagle device (Belkin Vision) for direct SLT. Despite the LiGHT trial sup- porting the benefits of first-line SLT therapy for open-angle glaucoma, Dr. Solberg said its adoption has been slow. Rea- sons could be the current technology's gonio lens-contact procedure, the time it takes, its side effects (though tran- sient and mild), and the fact that it's not widely provided. The tabletop Eagle system, Dr. Solberg explained, uses advanced imaging to locate the exact treatment area and within 2 seconds, 120 laser applications are applied, delivering the SLT treatment. The first in-human trial of 15 patients showed the technology to be safe and effective. It reduced IOP, on average, by 22%, and of the 14 patients in the study who were on medications, 11 were medica- tion-free 6 months post-treatment. Dr. Solberg said the technology is in a pivotal trial out- side the U.S. comparing direct SLT to traditional SLT with primary results expected by early next year. Gilad Litvin, MD, discussed the CorNeat KPro, a completely synthetic artificial cornea. The device features a nanofabric skirt, manufactured through electrospinning technology, that facilitates integration with resident ocular tissue. Dr. Litvin detailed the histological findings accumu- lated from in vitro and animal research, showing collagen deposition, cellular invasion and proliferation, and capil- lary formation within the skirt. This mechanism anchors the device to the subconjunctival space, which heals vigorously, according to Dr. Litvin. The device has under- gone animal studies and the first in-human implantation occurred earlier this year. Overall, Dr. Litvin said the technology highlights the ability to integrate artificial, mechanical, and other synthet- ic components into the human body seamlessly. continued from page 32 ASCRS NEWS 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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