Dexycu for post-cataract surgery inflammation
Publish date 06-05-2018


Dexycu for post-cataract surgery inflammation

 

 

 


Dexycu for post-cataract surgery inflammation



Dexamethasone intraocular suspension (Dexycu) is a sustained-release corticosteroid indicated for intraocular administration for the treatment of postoperative inflammation.

Dexycu is a sterile suspension with a white to off-white color. Dexycu is supplied in a 2 mL vial that

With the current standard of care, patients who underwent cataract surgery are placed on a treatment regimen comprised of self-administered anti inflammatory eye drops. The number of medications and frequency in use may cause non-compliance and dosing errors especially in elderly patients. Dexycu, on the other hand, is injected at the end of the surgery.

It is a single-dose formula that benefits the patient and the medical provider too. Dexycu, which is a single injection administration, aims to eliminate non-compliance or medication misuse associated with self-administration of post-operative eye drops. This helps to properly manage post cataract eye surgery patients and reduce the risks of cataract surgery complications.

Dexycu uses Icon Bioscience, Inc.’s Verisome drug-delivery technology to administer a biodegradable extended-release dexamethasone formula into the eye.

The Verisome technology drug delivery system has topical, systemic and ocular applications. Its products can be administered by injection, simultaneously delivering the drug over extended periods of time while the Verisome system degrades. According to human clinical trials, the delivery duration with a standard intraocular injection lasts for up to one year.
 

Possible Adverse Effects of Dexycu

 

  • Increased intraocular pressure (IOP)

  • Corneal edema

  • Delayed healing

  • Exacerbation of bacterial, viral or fungal infections.

  • Inflammation of the iris (iritis)

  • Dry eyes

  • Eye pain

  • Foreign-body sensation

  • Blepharitis

  • Inflammation in the eye

  • Blurred vision

  • Seeing floaters

  • Hypersensitivity to light

  • Cystoid macular edema

  • Corneal endothelial cell loss

  • Posterior Vitreous detachment

  • Decreased visual acuity

  • Development or progression of cataract in phakic patients

 

 

 

Precautions with Dexycu
 

  • Pregnancy – There’s no supporting studies of Dexycu in pregnant women. Adverse reactions were noted in clinical studies with mice and rabbits.

  • Lactation – It is not known whether injected Dexycu is passed in human milk or what is the effect on breastfed infants.

  • Pediatric patients – There’s no established data on the safety and efficacy of Dexycu in pediatric patients.


Clinical Studies

Dexycu underwent a randomized, placebo-controlled trial to determine its efficacy. The baseline for the trial was the anterior chamber cell clearing on the 8th postoperative day. The anterior chamber cells were assessed by thee examination of the anterior chamber with slit lamp microscope until one-month post treatment.

The clinical trial was composed of a placebo group, a 342 microgram treatment group, and a 517 microgram treatment group. On day 8 postoperative, patients with clear anterior chamber was 20% in the placebo group, 57% in the 342 microgram group, and 60% in the 517 microgram group.



FDA Approval

On February 12, 2018, Icon Bioscience, Inc. announced that the United States Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Dexycu for the treatment of inflammation after cataract surgery. Dexycu is the first FDA-approved long-acting intracameral drug for post-cataract surgery inflammation.