EyePoint Pharmaceuticals, Inc. - U.S. Commercialization of DEXYCU® (dexamethasone intraocular suspension) 9%
– DEXYCU is the first and only FDA-approved, single-dose, sustained-release, intracameral steroid for the treatment of postoperative inflammation
EyePoint Pharmaceuticals, Inc., a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, commercially launched DEXYCU® (dexamethasone intraocular suspension) 9% in March 2019 in the United States. DEXYCU is the first and only U.S. Food and Drug Administration (FDA) approved intraocular steroid for the treatment of postoperative inflammation and is administered as a single dose at the end of cataract surgery.
DEXYCU was initially launched to leading cataract surgery experts, to ensure proper training on DEXYCU’s administration and is now available to the broader ophthalmology community. The Centers for Medicare and Medicaid Services (CMS) has assigned a specific and permanent reimbursement J-code for DEXYCU, J1095, through the Healthcare Common Procedure Coding System (HCPCS) that became effective on January 1, 2019. The J-code has replaced the previously issued C-code for DEXYCU (C9034) that became effective on October 1, 2018.
DEXYCU is the first sustained-release, intracameral steroid approved by the FDA for the treatment of postoperative inflammation. Cataract surgery is the most frequent surgical procedure in the U.S., with approximately 4.8 million performed annually. DEXYCU employs the Company’s Verisome® sustained-release drug delivery technology to deliver a biodegradable formulation of the steroid dexamethasone behind the iris in the inferior portion of the posterior chamber of the eye via a single injection at the end of surgery. In most patients, this may eliminate self-administering steroid eye drops up to four times a day for several weeks on a titrated schedule, in a primarily elderly patient population. The cumulative percentage of subjects receiving rescue medication of ocular steroid or nonsteroidal anti-inflammatory drug (NSAID) at day 30 was significantly lower in the DEXYCU (517 mcg) treatment group (20%; n=31/156) compared to placebo (54%; n=43/80).
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
Link to the full Prescribing Information:
DEXYCU is a registered trademark and the EyePoint logo is a trademark of EyePoint Pharmaceuticals, Inc. Verisome is a registered trademark of Ramscor, Inc.
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