Michael Savetsky: DEXYCU® (dexamethasone intraocular suspension) 9% Utilization
Michael Savetsky on the first — and only — FDA-approved intraocular steroid for postoperative inflammation
sponsored by EyePoint Pharmaceuticals
What is DEXYCU?
DEXYCU® (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation (1).
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.
Which patients are appropriate for DEXYCU?
Many of my surgical patients are appropriate for DEXYCU® (dexamethasone intraocular suspension) 9%. Sustained-release DEXYCU is a one-time intraocular treatment that may eliminate the need for steroid drops (1), which in some regimens can include 70 or more drops over four weeks (4). I might be more careful in using it in a patient who has glaucoma or is a steroid responder. In the pivotal clinical trial, the percentage of patients who received DEXYCU (517 mcg) who had anterior chamber cell clearing on day eight was 60 percent (n=94/156) vs 20 percent (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) by day 30 was significantly lower in the DEXYCU 517 mcg treatment group (20 percent; n=31/156) compared to placebo (54 percent; n=43/80) (1).
What do the clinical trial results mean to you?
I actually participated in the trials and the final results are similar to what I see in my current patients. In the clinical trial, DEXYCU significantly improved the rate of complete AC cell clearing at day eight vs the placebo group (1).
What does the safety data mean to you?
I think the main issue is to always take into account the possibility of a spike in IOP (intraocular pressure). Patients with conditions that are susceptible to this, such as a steroid responder or glaucoma, should be watched closely or considered to be managed in a different way.
How has your patients’ experience been with DEXYCU?
My patients are very happy to receive a one-time steroid treatment during surgery. Personally, I find the anterior chamber to be cleared of cells soon after surgery.
INDICATION AND USAGE
IMPORTANT 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
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
• 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.
Michael Savetsky is a Partner at SightMD in Manhattan, NY, USA, specializing in refractive cataract surgery, LASIK, PRK, corneal transplantation, dry eye and keratoconus.
DEXYCU and the DEXYCU logo are registered trademarks and the EyePoint logo is a 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
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- DEXYCU® (dexamethasone intraocular suspension) 9% full U.S. Prescribing Information. EyePoint Pharmaceuticals, Inc. December 2018.
- E Donnenfeld and E Holland, “Dexamethasone intracameral drug-delivery suspension for inflammation associated with caratact sugery: a randomized, placebo-controlled, phase III trial”, Ophthalmology, 125, 700-806 (2018).
- Data on file, EyePoint Pharmaceuticals, Inc.
- Durezol (difluprednate ophthalmic emulsion) 0.05 % full US Prescribing Information. Alcon Laboratories, Inc.