Jason Bacharach: DEXYCU® (dexamethasone intraocular suspension) 9% Utilization
Jason Bacharach on the first — and only — FDA-approved intraocular steroid for postoperative inflammation
sponsored by EyePoint Pharmaceuticals
What makes DEXYCU unique?
DEXYCU® (dexamethasone intraocular suspension) 9% is the first and only FDA-approved intraocular steroid for postoperative inflammation (1, 2, 3). This single-dose, sustained-release treatment option delivered by the surgeon towards the conclusion of the procedure reduces my concerns because the product may reduce the need for topical anti-inflammatory eye drops as shown in the phase 3 clinical trial. Verisome® technology is the unique platform that elutes the active ingredient – dexamethasone (2). It is a biocompatible, biodegradable platform delivering a high initial dose that decreases over time providing a sustained clinical effect up to 30 days (2, 3, 4). The topical steroid drop regimen, which can include 70 or more drops over 4 weeks, may be eliminated for the patient (5). Since the medication is placed directly into the eye, there may be reduced surface toxicity as a result of reduced exposure to preserved eye drops (6). The percentage of patients who received DEXYCU 517-mcg who had anterior chamber cell clearing on day 8 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 types of patients would benefit from DEXYCU?
DEXYCU has no contraindications and may ultimately make sense for treating post-operative inflammation in all my cataract surgery cases (1). There are certainly particular patients that could benefit.
What do the clinical trial results mean to you?
Pivotal trials conducted here in the United States demonstrated compelling results for both efficacy and safety. Two trials were conducted in randomized, double-masked fashion to assess efficacy and safety of the treatment. DEXYCU was studied in a randomized, double-masked, placebo-controlled trial (1). Patients received either DEXYCU or a vehicle to assess efficacy and safety of the treatment. A single dose of DEXYCU equivalent to five microliters (517-mcg) was assessed at day eight post-op for cellular clearing in the anterior chamber. This was the primary efficacy endpoint: 60 percent of eyes in the DEXYCU group met this endpoint (1). The primary endpoint was the proportion of patients with complete AC cell clearing (cell score=0) on postoperative day 8. 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). Additionally the use of rescue medications was also significantly less in the DEXYCU group than placebo (1). In a phase 3 clinical trial, mean IOP elevations in the placebo and DEXYCU treatment groups were transient at day 1 and returned to baseline by day 3 (3). The most commonly reported adverse reactions, occurring in five percent to 15 percent of subjects, included increases in intraocular pressure, corneal edema and iritis (1).
How has your patient experience been with DEXYCU?
There is a learning curve with any new technology and DEXYCU is no exception. Getting the Verisome spherule to sit behind the iris can occasionally be a challenge and is technique dependent. By the end of my first day using DEXYCU, I felt comfortable with my technique of delivery. Importantly, even for those eyes that had some of the DEXYCU migrate into the anterior chamber, the postoperative results matched the clinical trials (3).
Jason Bacharach is Founder and Medical and Research Director of North Bay Eye Associates, California, and Co-Chair of the Department of Glaucoma at California Pacific Medical Center, USA.
INDICATION AND USAGE
DEXYCU® (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation.
IMPORTANT SAFETY INFORMATION
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
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.
- N Haghjou et al., “Sustained release intraocular drug delivery device for treatment of uveitis”, J Ophthalmic Vis Res, 6, 317-329 (2011).
- Durezol (difluprednate ophthalmic emulsion) 0.05% full US Prescribing Information. Alcon Laboratories, Inc.
- L Jones, LE Downie, D Korb et al., "TFOS DEWS II Management and Therapy Report", Ocul Surf, 15, 575-628 (2017).
- E Donnenfeld et al., J Cataract Refract Surg. (2018).