Outpatient Surgery Magazine

Patient Experience - June 2019 - Subscribe to Outpatient Surgery Magazine

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

Issue link: http://outpatientsurgery.uberflip.com/i/1131499

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Page 66 of 112

Target Within 1-3 With a single injection at the end of cataract surgery, anti-inflammatory efficacy begins as early as day 1 and continues through day 30 1 * • The percentage of patients who received DEX YCU (517 mcg) who had anterior chamber cell clearing on day 8 was 60% (n=94/156) vs 20% (n=16/80) in the placebo group 1 • The cumulative percentage of subjects receiving rescue medication of ocular steroid or nonsteroidal anti-inflammatory drug (NSAID) at day 30 was significantly lower in the DEX YCU (517 mcg) treatment group (20%; n=31/156) compared to placebo (54%; n=43/80) 1 01/2019 US-DEX-1900045 * DEX YCU was studied in a randomized, double-masked, placebo-controlled trial. Patients received either DEX YCU or a vehicle administered by a physician at the end of the surgical procedure. The primar y endpoint was the propor tion of patients with anterior chamber cell clearing (cell score=0) on postoperative day 8. DEXYCU and the EyePoint logo are trademarks of EyePoint Pharmaceuticals, Inc. © 2019 EyePoint Pharmaceuticals, Inc. All rights reserved. 480 Pleasant Street, Suite B300, Watertown, MA 02472 References: 1. DEXYCU ™ (dexamethasone intraocular suspension) 9% full U.S. Prescribing Information. EyePoint Pharmaceuticals, Inc. December 2018. 2. Donnenfeld E, Holland E. Dexamethasone intracameral drug-delivery suspension for inflammation associated with cataract surgery: a randomized, placebo-controlled, phase III trial. Ophthalmology. 2018;125(6):799-806. 3. Data on file. EyePoint Pharmaceuticals, Inc. The first and only FDA-approved, single-dose, sustained-release, intracameral steroid for the treatment of postoperative inflammation 1-3 NEW For Post-Cataract Surgery Inflammation INDICATION AND USAGE DEXYCU ™ (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Increase in Intraocular Pressure . Prolonged use of corticosteroids, including DEXYCU, 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 Delayed Healing . The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation . In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of corticosteroids Exacerbation of Infection . The use of DEXYCU, as with other ophthalmic corticosteroids, is not recommended in the presence of most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures . Use of a corticosteroid in the treatment of patients with a history of herpes simplex requires caution and may prolong the course and may exacerbate the severity of many viral infections . Fungal infections of the cornea are particularly prone to coincidentally develop with long-term local steroid application and 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 . Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection Cataract Progression . The use of corticosteroids in phakic individuals may promote the development of posterior subcapsular cataracts ADVERSE REACTIONS . The most commonly reported adverse reactions occurred in 5-15% of subjects and included increases in intraocular pressure, corneal edema and iritis Please see brief summary of full Prescribing Information on adjacent page. NOW AVAILABLE

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