Ehsan Sadri, M.D., FACS, FAAO
Dr. Ehsan Sadri is board-certified and fellowship-trained in cataract surgery, LASIK and glaucoma surgery. He is trained in the most progressive ocular surgical techniques including cataract surgery, phakic intraocular lenses, LASIK, PRK, refractive lensectomy, and AK.
DEXYCU® (dexamethasone intraocular suspension) 9% is an innovative product for the treatment of inflammation after ocular surgery.1 DEXYCU is administered into the posterior chamber at the end of the surgical procedure and utilizes patented Verisome® Technology designed to release dexamethasone at the target site in a controlled, tapered manner over a period of a few weeks.1-4
By placing the medication at the site of inflammation, it eliminates the concerns of drug penetration through the cornea.5 DEXYCU has a role in treating a wide variety of cataract surgery patients, and for some patients, it may eliminate the need for steroid drops that can involve 70 or more doses over a 4- week period.1,6
- 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
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
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.
Clinical trial experience with DEXYCU also gives me confidence. I was an investigator in an initial study, and I had particular concern about the potential for IOP elevations with an intraocular steroid because I am a glaucoma specialist. 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 common side effects with DEXYCU were increased intraocular pressure, corneal edema, and iritis.1
I like that DEXYCU can be visualized while it is being injected. As with any new surgical procedure, there is a learning curve for placing DEXYCU. I believe surgeons will find that proficiency is easily acquired, however, and so they should not be discouraged if they feel their technique is less than perfect in their initial cases.
I prefer to deliver DEXYCU by entering the eye through the sideport incision because this approach limits the potential for anterior chamber flattening compared with entry through the main incision. Surgeons who wish to use the main incision may consider introducing a small amount of viscoelastic first to help maintain a well-formed chamber.
DEXYCU should be placed behind the iris plane, and I deliver the medication using a fanned motion, moving the tip of the cannula from the 5 o’clock to the 3 o’clock position. Distributing the DEXYCU droplet in this manner helps to keep it behind the iris. Some of the material may migrate into the anterior chamber.7 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
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.
- 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.
- Gaudana R, Ananthula HK, Parenky A, Mitra AK. Ocular drug delivery. AAPS J. 2010;12(3):348-360.
- Durezol® (difluprednate ophthalmic emulsion) 0.05% full U.S. Prescribing Information. Alcon Laboratories, Inc.
- 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.
DEXYCU and the DEXYCU logo are registered trademarks 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.