Dosing a steroid drop four times a day after cataract surgery has been etched in stone as the correct and proper method of treating postoperative inflammation. Millions of cataract surgeries are performed every year, with postoperative treatment requiring a regimen of steroid, antibiotic, and nonsteroidal anti-inflammatory drug (NSAID) eyedrops that can total over 70 steroid drops.1-4
EyePoint Pharmaceuticals, Inc., launched DEXYCU® (dexamethasone intraocular suspension) 9%, which is the first and only intraocular steroid approved by the US Food and Drug Administration (FDA) for the treatment of postoperative inflammation and is administered as a single dose at the end of cataract surgery.5-7
INDICATION AND USAGE
DEXYCU® (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation.
IMPORTANT SAFETY INFORMATION
Please see continued Important Safety Information below and link to full Prescribing Information.
DEXYCU has proven efficacy in a single dose, as complete anterior chamber (AC) cell clearing started as early as day 1 and continued through day 30.5 The percentage of patients who received DEXYCU (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.5 In the studies, the cumulative percentage of subjects receiving rescue medication of ocular steroid or nonsteroidal anti-inflammatory drug (NSAID) by day 30 was significantly lower in the DEXYCU (517 mcg) treatment group (20%; n=31/156) compared to placebo (54%; n=43/80).5 I have found that although DEXYCU may not replace all drops, this one-time treatment may eliminate the need for the steroid drops.1-7
I have begun to incorporate the use of DEXYCU into my cataract surgeries and feel comfortable that I can use this product in many patients.1-7 DEXYCU employs patented Verisome® Technology sustained-release drug delivery, which is a biodegradable sphere that disperses dexamethasone over an extended time period.7,8
As a surgeon, managing inflammation is critical in achieving the intended outcomes after the completion of the case and in preventing serious complications. Thus far after incorporating DEXYCU at the end of surgery into the posterior chamber of the eye, I have not had the need to supplement these regimens with additional steroid eye drops due to breakthrough or persistent inflammation.1,5
DEXYCU fits into my surgical routine and helps put control in place with a single dose.1 OM
Graphic illustration of DEXYCU administrationIMPORTANT SAFETY INFORMATION (cont’d)
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
- 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
- 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
- The use of corticosteroids in phakic individuals may promote the development of posterior subcapsular cataracts
- The most commonly reported adverse reactions occurred in 5-15% of subjects and included increases in intraocular pressure, corneal edema and iritis
Please see full Prescribing Information for DEXYCU.
About the author:
- Durezol® (difluprednate ophthalmic emulsion) 0.05% full U.S. Prescribing Information. Alcon Laboratories, Inc. April 2017.
- Besivance® (besifloxacin ophthalmic suspension) 0.6% full U.S. Prescribing Information. Bausch & Lomb Incorporated. April 2018.
- Prolensa® (bromfenac ophthalmic solution) 0.07% full U.S. Prescribing Information. Bausch & Lomb Incorporated. June 2016.
- Dua HS, Attre R. Treatment of post-operative inflammation following cataract surgery – a review. Eur Ophthalmic Rev. 2012;6(2):98-103.
- DEXYCU® (dexamethasone intraocular suspension) 9% full U.S. Prescribing Information. EyePoint Pharmaceuticals, Inc. December 2018.
- 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.
- Data on file. EyePoint Pharmaceuticals, Inc.
- Haghjou N, Soheilian M, Abdekhodaie MJ. Sustained release intraocular drug delivery devices for treatment of uveitis. J Ophthalmic Vis Res. 2011;6(4):317-329.
DEXYCU is a registered trademark of EyePoint Pharmaceuticals, Inc. Verisome is a registered trademark of Ramscor, Inc. ©2019 EyePoint Pharmaceuticals, Inc. All rights reserved. 480 Pleasant Street, Suite B300, Watertown, MA 02472