Targeted Anti-inflammatory Steroid Treatment^1,2

With the FDA approval of DEXYCU^® (dexamethasone intraocular suspension) 9%, physicians and patients now have a different way to treat postoperative inflammation following cataract surgery. DEXYCU is indicated for the treatment of postoperative inflammation.¹ DEXYCU, a single 0.005-mL intracameral injection administered at the end of the procedure, may eliminate the need for steroid drops.^1,2 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 I participated in the DEXYCU clinical trial and have been using it for my patients, so I can offer some tips for administration following cataract surgery.

IMPORTANT SAFETY
INFORMATION

CONTRAINDICATIONS

None.

Please see continued Important Safety Information throughout this article and adjacent Brief Summary.

INTEGRATING DEXYCU

DEXYCU is provided in single-administration kits that contain six items: 1) one vial containing 0.5 mL of DEXYCU, 2) one sterile 1-mL syringe, 3) one sterile syringe guide, 4) one sterile syringe ring, 5) one sterile 18-ga. needle, and 6) one sterile 25-ga. bent cannula. Detailed instructions for administering DEXYCU^® (dexamethasone intraocular suspension) 9% can be found at DEXYCU.com . The ring snaps loosely onto the syringe in front of the plunger flange. In a subsequent step, the guide is placed over the ring. This system helps to ensure the correct volume of drug is administered.¹

In my OR, an assistant prepares DEXYCU for administration. While I’m inserting the IOL, the assistant shakes the vial to mix the suspension and draws up the medication.¹ When I’m finished removing the viscoelastic from the patient’s eye, the assistant hands the DEXYCU syringe to me. I place the syringe guide, prime the cannula (depress the plunger until it reaches the guide and tap off excess drug from the tip of the cannula), remove the guide, and inject the medication into the posterior chamber inferiorly behind the iris.¹ Formulated with Verisome^® drug delivery technology, the medication forms a sphere inside the eye, which should be no larger than 2 mm.² By design, after preparation and injection some medication remains in the syringe.¹

Injecting such a small amount of drug into the eye and working under BSS (balanced salt solution) rather than viscoelastic make surgeons’ first cases with DEXYCU different from their current cataract surgery routine. The difference should be less abrupt for surgeons who have experience performing any surgical maneuver under air, as I did as a fellow. I recommend that surgeons new to DEXYCU draw up 0.2 mL of the medication in the vial at first. The remainder is enough to enable a second chance at proper injection if necessary. It is important to inject slowly for accurate placement into the intended area. For the first several DEXYCU^® (dexamethasone intraocular suspension) 9% patients, it may also be helpful to hydrate the wounds and slightly overfill the anterior chamber with BSS prior to injecting. This provides some latitude in the event of any fluid egress as the cannula enters the eye.

Since my earliest cases, I’ve made one change to facilitate DEXYCU injections. To help avoid shallowing of the anterior chamber, I inject through the paracentesis rather than the main incision.

In clinical studies that compared DEXYCU to placebo, fewer patients who received DEXYCU needed additional medications (such as ocular steroids or nonsteroidal anti-inflammatory eyedrops) for inflammation.¹ Significantly fewer DEXYCU subjects vs placebo received ocular steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) (rescue medication) on days 3, 8, 15, and 30, including 10% (n=16/156) vs. 50% (n=40/80) at day 8; rescue medication use=failure.²

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

Please see continued Important Safety Information throughout this article and adjacent Brief Summary.

REIMBURSEMENT

CMS has designated DEXYCU^® (dexamethasone intraocular suspension) 9% as a pass-through drug and issued a J-code (J1095) that became effective Jan. 1, 2019. Therefore, ASCs should expect a straightforward reimbursement process. To give our ASC time to confirm which commercial insurers cover DEXYCU, I’ve gradually increased the number of cases in which I use it. To maximize access to this option for patients, EyePoint has assistance and copay assistance programs in place. The company also runs an assurance program for ASCs to help ease concerns they may have about commercial payers’ reimbursement for DEXYCU. Under this program, if a surgery center follows all the necessary steps for qualifying patients for DEXYCU coverage, and the payer doesn’t pay, EyePoint will issue the center a trade credit for a DEXYCU kit.

SEE THE RESULTS

In a phase 3, randomized, double-masked, placebo-controlled trial (n=236), DEXYCU was shown to significantly improve the rate of complete anterior chamber cell clearing at post-op day 8.^1,2 Three times more DEXYCU patients (60%; n=94/156 vs 20%; n=16/80) had complete anterior chamber cell clearing versus placebo 8 days after surgery.^1,2

DEXYCU was studied in a randomized, double-masked, placebo-controlled trial. 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.^1,2

DEXYCU^® (dexamethasone intraocular suspension) 9% fits into my surgical routine and helps put control in place with a single dose.¹

Dr. Savetsky is a surgeon with SightMD, which serves patients in New York City and its suburbs.

REFERENCES

1. DEXYCU (dexamethasone intraocular suspension) 9% full U.S. Prescribing Information. EyePoint Pharmaceuticals, Inc. December 2018.
2. Data on file. EyePoint Pharmaceuticals, Inc.

IMPORTANT SAFETY
INFORMATION (CONT’D)

WARNINGS AND PRECAUTIONS (CONT’d)

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 see brief summary of full Prescribing Information on pages 53-54.

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