DEXYCU for Post-Surgical Inflammation in Childhood Cataract

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: EyePoint Pharmaceuticals, Inc.

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have received certain corticosteroid treatments in the study eye recently, you may not be eligible.

What data supports the idea that DEXYCU for Post-Surgical Inflammation in Childhood Cataract is an effective treatment?

The available research shows that DEXYCU, a form of dexamethasone, is effective in managing inflammation after cataract surgery. In a study comparing DEXYCU with prednisolone acetate eye drops, DEXYCU was found to be effective in reducing inflammation. Another study on a similar dexamethasone treatment (Dextenza) showed that it reduced or eliminated the need for additional steroid drops in children after cataract surgery. This suggests that DEXYCU can be a good option for managing post-surgical inflammation in childhood cataract. ^{1 2 3 4 5}

What safety data is available for DEXYCU in treating post-surgical inflammation in childhood cataract?

DEXYCU, a dexamethasone intraocular suspension, is FDA-approved for postoperative inflammation and provides sustained release of medication. Safety data from various studies indicate that it is effective in reducing inflammation with a controlled release mechanism. In a study involving pediatric cataract surgery, 18% of eyes experienced a spike in intraocular pressure, and 29% required additional topical steroids. Another study compared DEXYCU with prednisolone acetate drops, highlighting its safety and efficacy. Overall, DEXYCU minimizes contact with sensitive eye tissues and allows for controlled drug delivery, enhancing safety and efficiency. ^{1 2 5 6 7}

Is the drug Dexamethasone a promising treatment for post-surgical inflammation in childhood cataract?

Yes, Dexamethasone, especially in its sustained-release form like Dexycu, is promising for reducing inflammation after cataract surgery. It allows for controlled delivery directly to the eye, reducing the need for frequent eye drops and ensuring the drug reaches the target area effectively. ^{1 5 6 7 8}

Eligibility Criteria

This trial is for children undergoing routine cataract surgery, with or without lens implantation. Participants must not have post-traumatic cataracts, eye infections, high eye pressure over 25 mmHg even with treatment, or recent corticosteroid injections in the eye. They should also be free of major health issues that could increase risks.

Inclusion Criteria

Other protocol-specified inclusion criteria may apply

I am having a straightforward cataract surgery, with or without lens implant.

My contact lens for after cataract surgery is silicone or rigid gas permeable.

Exclusion Criteria

My eye pressure is over 25 mmHg, even with treatment.

I have a cataract caused by an injury.

I do not have any major health issues that could make the trial unsafe for me.

Treatment Details

Interventions

• Dexamethasone (Corticosteroid)
• Prednisolone Acetate Ophthalmic (Corticosteroid)

Trial Overview The study compares DEXYCU (a dexamethasone-based drug) to Prednisolone Acetate Ophthalmic to see which is safer for reducing inflammation after a child's cataract surgery. It's a controlled test where patients are randomly assigned to one of the treatments.

Participant Groups

Group I: DEXYCU (dexamethasoneintraocular suspension) 9% Experimental Treatment 1 Intervention

A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.

Group II: Prednisolone acetate ophthalmic suspension (USP) 1% Active Control 1 Intervention

Active treatment control, prednisolone acetate ophthalmic suspension (USP) 1%, four times daily (QID) for 28days, followed by a treatment taper at the investigator's discretion.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

🇺🇸 Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

🇨🇦 Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

🇯🇵 Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

EyePoint Investigational Site Palo Alto, CA

EyePoint Investigative Site Boston, MA

EyePoint Investigational Site Charleston, SC

EyePoint Investigational Site Buffalo, NY

More Trial Locations

Who Is Running the Clinical Trial?

EyePoint Pharmaceuticals, Inc. Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

A sustained-release intracanalicular dexamethasone insert (Dextenza) for pediatric cataract surgery. [2021] We assess the outcomes of a sustained-release intracanalicular dexamethasone insert (Dextenza) in the treatment of postoperative ocular inflammation in children undergoing cataract surgery. Seventeen eyes of 17 children were analyzed. The anterior chamber was clear in 18% of eyes at 1-2 weeks after surgery. A spike in intraocular pressure requiring intervention was observed in 18% of eyes. Rescue medications using topical steroids were required in 29% of eyes. Our initial experience suggests that the dexamethasone insert reduced or eliminated the need for postoperative steroid drops.

2. England pubmed.ncbi.nlm.nih.gov

Anti-inflammatory medication following cataract surgery: a randomized trial between preservative-free dexamethasone, diclofenac and their combination. [2018] To examine the anti-inflammatory efficacy and tolerance between preservative-free dexamethasone (DEX) and diclofenac (DICL) eye drops, and their combination following cataract surgery.

3. New Zealand pubmed.ncbi.nlm.nih.gov

First Real-World, Multicenter, Post-Marketing, Retrospective Study of Dexamethasone Intraocular Suspension for Inflammation After Cataract Surgery. [2022] To evaluate dexamethasone intraocular suspension 9% (intraocular DXM) in real-world clinical use to manage inflammation associated with cataract surgery.

4. United States pubmed.ncbi.nlm.nih.gov

Effect of intracameral triamcinolone acetonide on postoperative intraocular inflammation in pediatric traumatic cataract. [2018] To study the effect of a single intracameral injection of triamcinolone acetonide at the end of pediatric traumatic cataract surgery on postoperative inflammation.

5. United States pubmed.ncbi.nlm.nih.gov

Safety of IBI-10090 for inflammation associated with cataract surgery: Phase 3 multicenter study. [2019] To compare the safety and efficacy of IBI-10090 anterior chamber intracameral dexamethasone drug-delivery suspension (Dexycu) with those of prednisolone acetate 1.0% ophthalmic drops in treating inflammation after cataract surgery.

6. England pubmed.ncbi.nlm.nih.gov

Dexamethasone intracameral drug-delivery suspension for inflammation associated with vitreoretinal surgery. [2022] To evaluate the efficacy of an anterior chamber intracameral dexamethasone (ICD) drug-delivery suspension (Dexycu; EyePoint Pharmaceuticals, Watertown, Massachusetts, USA) providing sustained release of medication following a single application for the treatment of postoperative inflammation in patients undergoing vitreoretinal surgery compared to daily postoperative treatment with topical corticosteroids for up to 1 month.

7. New Zealand pubmed.ncbi.nlm.nih.gov

Real-World Experience with Intracapsular Administration of Dexamethasone Intraocular Suspension 9% for Control of Postoperative Inflammation. [2022] Corticosteroids and non-steroidal anti-inflammatory drugs are commonly used prophylactically to control inflammation after ocular surgery. When prescribed as eye drops, as has been longstanding tradition, anti-inflammatory success is out of surgeons' hands, dependent on patient compliance and proper instillation technique. Sustained-release, intraoperatively administered anti-inflammatory drugs are emerging as another option. DEXYCU (dexamethasone intraocular suspension) 9% is the first and only intraocular corticosteroid FDA-approved for postoperative inflammation, whose sustained-release formulation provides a high initial release of drug, followed by a gradual tapering. Administration of the drug directly into the capsular bag following cataract surgery enables reliable placement proximal to target tissues, ensuring surgeon control and visibility of delivery, safety, and efficiency. This technique also minimizes contact with metabolically active tissues such as the corneal endothelium, iris, and ciliary body. In this paper, we review the available literature on dexamethasone intraocular suspension and summarize surgeons' consensus on best practices for intracapsular administration.

8. United States pubmed.ncbi.nlm.nih.gov

Iris Atrophy After Administration of Intracameral Dexycu in Routine Cataract Surgery: A Case Series. [2023] Dexycu (Icon Bioscience INC, Newark, CA) is an FDA-approved single-dose, sustained release intracameral steroid designed to mitigate postoperative inflammation after cataract surgery as an alternative to topical steroid therapy. The purpose of this study was to look at long-term and adverse events associated with Dexycu use. Eighteen eyes from nine patients who underwent cataract surgery were included. Patients were followed for an average of 97 days (range 28-319 days) after surgery on the first eye. Thirteen eyes were treated with Dexycu, and the other five eyes were treated with standard postoperative anti-inflammatory drops. Four of the thirteen eyes receiving Dexycu developed clinically evident iris atrophy (30.7%). None of the five eyes treated with traditional anti-inflammatory drops developed iris atrophy. The Dexycu intraocular dexamethasone implant was designed to mitigate postoperative inflammation and reduce need for topical therapy but may be associated with other potential adverse effects that warrant consideration.