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Contact Name: by Title ASCRS NEWS to controls. While mean postoperative logMAR was not provided, 82.8% of cases with previous vitrectomy achieved a postoperative visual acuity of logMAR 0.3 or better, compared to 95.6% for the rest of the database. The data also revealed that dropped nucleus and surgical complications listed under "other" in the reported surgical data were significantly more frequent in the post-vitrecto- my eyes than in the rest of the database, though at a lower frequency than other comparable published studies. In- terestingly, other surgical difficulties such as small pupils, corneal opacities, or pseudoexfoliation were significantly less common in the previous vitrectomy group. The authors freely discussed many of the paper's lim- itations, including firstly that the relationship between pri- or vitrectomy and cataract surgery outcomes is confound- ed by many variables. The clinical indication for prior vitrectomy was not documented in the EUREQUO, which is a limitation of the database itself rather than the paper. Vitrectomy for retinal detachment versus a non-clear- ing vitreous hemorrhage are two very different disease processes and would likely have different effects on final visual acuity. Further stratification of the vitrectomy group based on clinical indication would provide a clearer understanding of why preoperative visual acuity is worse in vitrectomized patients. Preoperative visual acuity in the setting of other pathology also skews the postoperative visual acuity, and the authors astutely noted that preoper- ative visual acuity prior to the onset of cataract was not available in the database. Vision that is limited by cataract and prior vitreoretinal disease would likely also be limited by the same disease process postoperatively, regardless of the efficacy of surgery. Secondly, the EUREQUO dataset posed significant limitations, including limited follow-up, with nearly 18% of patients missing postoperative data, a lack of detail in the database discussing surgical diffi- culties or surgical complications beyond simply labeling them as "other," and biases in the data, which is generated from self-reporting by physicians or clinics. The authors reported significant differences in the rates of surgical difficulties and complications compared to previously published estimates in the literature, which may be the result of these limitations. Thirdly, a large database study may have produced statistically significant differences that are not clinically significant—the higher biometry-predict- ed refractive error in vitrectomized vs. non-vitrectomized eyes undergoing cataracts (0.52±0.75 D vs. 0.43±0.51) is one such result. Lundstrom et al. conducted an important large Euro- pean database study comparing cataract surgery outcomes in eyes that have undergone prior vitrectomy to those in non-vitrectomized eyes. Those with previous vitrectomy continued from page 22 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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