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Read PDF Edition REVIEW Wills Eye Resident Series: A 5-year-old girl with a suspicious “pink” eye, p.78 OF ® OPHTHALMOLOGY PLASTICS POINTERS Lower-lid Bleph Techniques Page 22 VOL. GLAUCOMA MANAGEMENT Virtual Reality-based Field Testing XXVIII, Page 64 NO. RETINAL INSIDER 3 review • How to Tackle Complex Macular Holes MARCH of opHTHALMOLOGY Page 70 March 2021 • reviewofophthalmology.com • Clinical advice you can trust 2021 • OPTIONS FOR IOL FIXATION BE PREPARED • REVIEW’S ANNUAL FOR ANYTHING Surgeons give you the tools you need CATARACT to handle tough cataract cases. TECHNIQUE • Secondary IOL Fixation: Know Your Options P. 34 SURVEY • E-Survey: Surgeons’ Favorite • Cataract Techniques P. 42 CATARACT • Extracting Cataracts in Uveitic SURGERY Glaucoma P. 48 IN UVEITIC GLAUCOMA ALSO INSIDE: • DIABETIC • Planning Your Diabetic Retinopathy Treatments P. 56 RETINOPATHY • Med-School Education: Teaching the Teachers P. 60 001_rp0321_fc2.indd 1 2/23/21 11:38 AM Give Ptosis Patients an EYE-OPENING Lift With a Daily Drop of Upneeq® (oxymetazoline hydrochloride ophthalmic solution), 0.1% 1 The only FDA-approved prescription eyedrop proven to lift upper eyelids in adults with acquired blepharoptosis (low-lying lids)1 Learn more at Upneeq.com. INDICATION ADVERSE REACTIONS Upneeq® (oxymetazoline hydrochloride ophthalmic Adverse reactions that occurred in 1-5% of subjects solution), 0.1% is indicated for the treatment of treated with Upneeq were punctate keratitis, acquired blepharoptosis in adults. conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation, and headache. IMPORTANT SAFETY INFORMATION DRUG INTERACTIONS WARNINGS AND PRECAUTIONS • Alpha-adrenergic agonists, as a class, may impact • Alpha-adrenergic agonists as a class may impact blood pressure. Caution in using drugs such as blood pressure. Advise Upneeq patients with beta blockers, anti-hypertensives, and/or cardiac cardiovascular disease, orthostatic hypotension, glycosides is advised. Caution should also be and/or uncontrolled hypertension or hypotension exercised in patients receiving alpha adrenergic to seek medical care if their condition worsens. receptor antagonists such as in the treatment • Use Upneeq with caution in patients with cerebral of cardiovascular disease, or benign prostatic or coronary insuffi ciency or Sjögren’s syndrome. hypertrophy. Advise patients to seek medical care if signs • Caution is advised in patients taking monoamine and symptoms of potentiation of vascular oxidase inhibitors which can affect the metabolism insuffi ciency develop. and uptake of circulating amines. • Upneeq may increase the risk of angle closure glaucoma in patients with untreated narrow-angle To report SUSPECTED ADVERSE REACTIONS glaucoma. Advise patients to seek immediate or product complaints, contact medical care if signs and symptoms of acute RVL Pharmaceuticals at 1-877-482-3788. narrow-angle glaucoma develop. You may also report SUSPECTED ADVERSE • Patients should not touch the tip of the single REACTIONS to the FDA at 1-800-FDA-1088 patient-use container to their eye or to any surface, or www.fda.gov/medwatch. in order to avoid eye injury or contamination of Please see next page for Brief Summary of full the solution. Prescribing Information. Reference: 1. Upneeq® (oxymetazoline hydrochloride ophthalmic solution), 0.1%. [Prescribing Information]. Learn more at Upneeq.com Distributed by: RVL Pharmaceuticals, Inc. Bridgewater, NJ 08807 PMS 541 C PMS 541 C PMS 908 C PMS 137 C PMS 908 CCustomer Service 1-866-600-4799 FONTSUpneeq is a registered trademark of RVL Pharmaceuticals, Inc. RVL: Verdigris MVB Pro Text PHARMACEUTICALS,©2021 INC.: RVL Forma DJR Pharmaceuticals, Text Inc. PM-US-UPN-0197 01/21 Untitled-1 1 1/19/2021 12:36:49 PM UPNEEQ® (oxymetazoline hydrochloride ophthalmic 8 USE IN SPECIFIC POPULATIONS * solution), 0.1%, for topical ophthalmic use 8.1 Pregnancy * Each mL of UPNEEQ contains 1 mg of oxymetazoline hydrochloride, equivalent to 0.09 mg (0.09%) of oxymetazoline free base. Risk Summary There are no available data on UPNEEQ use in pregnant women BRIEF SUMMARY: The following is a brief summary only; to inform a drug-associated risk for major birth defects and see full Prescribing Information at https://www.upneeq.com/ miscarriage. In animal reproduction studies, there were no Upneeq-PI.pdf for complete information. adverse developmental effects observed after oral administration of oxymetazoline hydrochloride in pregnant rats and rabbits 1 INDICATIONS AND USAGE at systemic exposures up to 7 and 278 times the maximum UPNEEQ is indicated for the treatment of acquired blepharoptosis recommended human ophthalmic dose (MRHOD), respectively, in adults. based on dose comparison. [see Data]. The estimated background risks of major birth defects and miscarriage for the indicated 2 DOSAGE AND ADMINISTRATION population are unknown. All pregnancies have a background risk Contact lenses should be removed prior to instillation of UPNEEQ of birth defect, loss, or other adverse outcomes. In the U.S. general and may be reinserted 15 minutes following its administration. population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15- If more than one topical ophthalmic drug is being used, the drugs 20%, respectively. should be administered at least 15 minutes between applications. Data 4 CONTRAINDICATIONS Animal Data None. Effects on embryo-fetal development were evaluated in rats and rabbits following oral administration of oxymetazoline hydrochloride 5 WARNINGS AND PRECAUTIONS during the period of organogenesis. Oxymetazoline hydrochloride 5.1 Potential Impacts on Cardiovascular Disease did not cause adverse effects to the fetus at oral doses up to 0.2 Alpha-adrenergic agonists may impact blood pressure. UPNEEQ mg/kg/day in pregnant rats during the period of organogenesis (28 should be used with caution in patients with severe or unstable times the MRHOD, on a dose comparison basis). Oxymetazoline cardiovascular disease, orthostatic hypotension, and uncontrolled hydrochloride did not cause adverse effects to the fetus at oral hypertension or hypotension. Advise patients with cardiovascular doses up to 1 mg/kg/day in pregnant rabbits during the period of disease, orthostatic hypotension, and/or uncontrolled hypertension/ organogenesis (278 times the MRHOD, on a dose comparison basis). hypotension to seek immediate medical care if their condition Maternal toxicity, including decreased maternal body weight, was worsens. produced at the high dose of 1 mg/kg/day in pregnant rabbits and was associated with findings of delayed skeletal ossification. 5.2 Potentiation of Vascular Insufficiency In a rat prenatal and postnatal development study, oxymetazoline UPNEEQ should be used with caution in patients with cerebral or hydrochloride was orally administered to pregnant rats once daily coronary insufficiency, or Sjögren’s syndrome. Advise patients to from gestation day 6 through lactation day 20. Maternal toxicity was seek immediate medical care if signs and symptoms of potentiation produced at the high dose of 0.2 mg/kg/day (28 times the MRHOD, of vascular insufficiency develop. on a dose comparison basis) in pregnant rats and was associated 5.3 Risk of Angle Closure Glaucoma with an increase in pup mortality and reduced pup body weights. UPNEEQ may increase the risk of angle closure glaucoma in patients Delayed sexual maturation was noted at 0.1 mg/kg/day (14 times the with untreated narrow-angle glaucoma. Advise patients to seek MRHOD, on a dose comparison basis). Oxymetazoline hydrochloride immediate medical care if signs and symptoms of acute angle did not have any adverse effects on fetal development at a dose of closure glaucoma develop. 0.05 mg/kg/day (7 times the MRHOD, on a dose comparison basis). 5.4 Risk of Contamination 8.2 Lactation Patients should not touch the tip of the single patient-use container Risk Summary to their eye or to any surface, in order to avoid eye injury or No clinical data are available to assess the effects of oxymetazoline contamination of the solution. on the quantity or rate of breast milk production, or to establish the level of oxymetazoline present in human breast milk post- 6 ADVERSE REACTIONS dose. Oxymetazoline was detected in the milk of lactating rats. The 6.1 Clinical Trials Experience developmental and health benefits of breastfeeding should be Because clinical trials are conducted under widely varying considered along with the mother’s clinical need for UPNEEQ and conditions, adverse reaction rates observed in the clinical trials of any potential adverse effects on the breastfed child from UPNEEQ. a drug cannot be directly compared to rates in the clinical trials of 8.4 Pediatric Use another drug and may not reflect the rates observed in practice. Safety and effectiveness of UPNEEQ have not been established in A total of 360 subjects with acquired blepharoptosis were treated pediatric patients under 13 years of age. with UPNEEQ once daily in each eye for at least 6 weeks in three 8.5 Geriatric Use controlled Phase 3 clinical trials, including 203 subjects treated with UPNEEQ for 6 weeks and 157 subjects treated with UPNEEQ for 12 Three hundred and fifteen subjects aged 65 years and older received weeks. Adverse reactions that occurred in 1-5% of subjects treated treatment with UPNEEQ (n = 216) or vehicle (n = 99) in clinical trials. with UPNEEQ were punctate keratitis, conjunctival hyperemia, dry No overall differences in safety or effectiveness were
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