Steven M. Silverstein, MD, FACS
Clinical Professor of Ophthalmology, Kansas City University of Medicine and Biomedical Sciences.
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.
In this video from a cataract surgery case, Steven M. Silverstein, MD, provides tips for injecting DEXYCU® (dexamethasone intraocular suspension) 9% into the posterior chamber at the end of ocular surgery to treat postoperative inflammation.1-3
Sustained-release DEXYCU is a novel intraocular product that may eliminate the need for steroid drops, which in some regimens can include 70 or more drops over 4 weeks.1,4 This one-time treatment provides most cataract surgery patients a corticosteroid that can help suppress postoperative inflammation over 30 days.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%; n=31/156) compared to placebo (54%; n=43/80)1
Clinical trial data demonstrated that DEXYCU is effective for clearing anterior chamber cells.1
- 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 group1
- DEXYCU was studied in a randomized, double-masked, placebo-controlled trial.1 Patients received either DEXYCU or a vehicle administered by a physician at the end of the surgical procedure. The primary endpoint was the proportion of patients with anterior chamber cell clearing (cell score = 0) on postoperative day 8.3
The most commonly reported adverse reactions occurred in 5-15% of subjects who received DEXYCU and included increases in intraocular pressure, corneal edema, and iritis.1 In a phase 3 clinical trial, mean intraocular pressure elevations in the placebo and DEXYCU treatment groups were transient at day 1 and returned to baseline by day 3.3
Since DEXYCU is placed at the site of inflammation, it eliminates concerns of this drug penetrating the cornea, ocular surface toxicity due to this medication, and washout by tearing or other drops being administered.5,6 I find that DEXYCU is easy to administer in my patients. After bringing the anterior chamber to normotension, I introduce the delivery cannula into the eye and advance it into the sulcus, directly across from the main incision, so that the tip is under the iris. Then, like laying down a bead of caulk, I inject DEXYCU while moving the cannula tip in a continuous motion towards 6 o’clock.
After DEXYCU is delivered, some of the medication may spill out of the sulcus into the anterior chamber. In a phase 3 multicenter, randomized study that compared the efficacy and safety of DEXYCU and prednisolone acetate, it was found that in 57% of the cases, DEXYCU did not remain behind the iris on Postoperative Day 1.7 Anticipating the possibility, patients should be told they may see a white “pearl” of medicine when they look in the mirror and that it will dissolve over time.2,8
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 inpiduals 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.
- 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 caratact surgery: a randomized, placebo-controlled, phase III trial. Ophthalmology. 2018; 125(6):700-806
- Data on file, EyePoint Pharmaceuticals Inc.
- Durezol® (difluprednate ophthalmic emulsion) 0.05% full U.S. Prescribing Information. Alcon Laboratories, Inc.
- Jones L, Downie LE, Korb D, et al. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017;15(3):575-628.
- Gaudana R, Ananthula HK, Parenky A, Mitra AK. Ocular drug delivery. AAPS J. 2010;12(3):348-360.
- Donnenfeld ED, Solomon KD, Matossian C. Safety of IBI-10090 for inflammation associated with cataract surgery: Phase 3 multicenter study. J Cataract Refract Surg. 2018;44(10):1236-1246.
- 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 and the EyePoint logo is trademark of EyePoint Pharmaceuticals, Inc. ©2019 EyePoint Pharmaceuticals, Inc. All rights reserved. 480 Pleasant Street, Suite B300, Watertown, MA 02472.