Study design1,2

Clinical efficacy was evaluated in a randomized, double-masked, placebo-controlled trial in patients who received either DEXYCU (342 mcg n=158; 517 mcg n=156) or a vehicle administered by a physician at the end of the surgical procedure (placebo n=80) (N=394). Use of ocular, periocular, or systemic corticosteroids, immunomodulators, alkylating agents, or ocular topical NSAIDs was not allowed through day 30 unless necessary; glaucoma and other ocular medications (including topical cyclosporine but excluding ocular topical NSAIDs) could be administered peri- and postoperatively as indicated. Patients who received corticosteroids or immunosuppressants for any condition (ocular or systemic) were followed through 90 days. The primary endpoint was the proportion of patients with complete AC cell clearing (cell score=0) on postoperative day 8.

INDICATION AND USAGE

DEXYCU® (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
None.
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
Delayed Healing
  • 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
Cataract Progression
  • The use of corticosteroids in phakic individuals may promote the development of posterior subcapsular cataracts
ADVERSE REACTIONS
  • The most commonly reported adverse reactions occurred in 5-15% of subjects and included increases in intraocular pressure, corneal edema and iritis
Please click here for full Prescribing Information.

References

1. DEXYCU® (dexamethasone intraocular suspension) 9% full U.S. Prescribing Information. EyePoint Pharmaceuticals, Inc. June 2020. 2. Data on file. EyePoint Pharmaceuticals, Inc. 3. 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. 

INDICATION AND USAGE

DEXYCU® (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
None.
DEXYCU, the DEXYCU logo, and the EyePoint logo are registered trademarks of EyePoint Pharmaceuticals, Inc.
Verisome is a registered trademark of Ramscor, Inc. EyePoint Assist is a service mark of EyePoint Pharmaceuticals, Inc.
©2022 EyePoint Pharmaceuticals, Inc. All rights reserved. 480 Pleasant Street, Suite B300, Watertown, MA 02472
THIS SITE IS INTENDED FOR U.S. HEALTHCARE PROFESSIONALS ONLY.
01/2020
US-DEX-2000003
04/2021
US-DEX-2100044
04/2021
US-DEX-2100055
10/2019
US-DEX-1900213
09/2020
US-DEX-2000144
11/2020
US-DEX-2000175
09/2021
US-DEX-2100183
12/2020
US-DEX-2000179
06/2021
US-DEX-2100128
09/2021
US-DEX-2100226
09/2021
US-DEX-2100161
09/2021
US-DEX-2100187
09/2021
US-DEX-2100227