DEXYCU for Post-Surgical Inflammation in Childhood Cataract

Recruiting at 8 trial locations

Overseen By Ramiro Ribeiro, MD, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: EyePoint Pharmaceuticals, Inc.

Must not be taking: Intravitreal corticosteroids

Disqualifiers: Ocular hypertension, Post-traumatic cataract, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to reduce inflammation after cataract surgery in children. It compares DEXYCU, a single injection of dexamethasone, to the usual month-long regimen of eye drops. The goal is to determine if DEXYCU is safe and effective. Children undergoing routine cataract surgery without major complications may be suitable candidates for this trial. As a Phase 4 trial, this research aims to understand how the already FDA-approved and proven effective treatment benefits a broader range of patients.

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for these treatments?

Research has shown that DEXYCU, a type of eye medication, is generally safe. In past studies, patients who received a single dose of DEXYCU during cataract surgery experienced no long-term negative effects. This treatment involves placing a small amount of medicine into the eye to reduce swelling after surgery.

DEXYCU has been used in adults after cataract surgery without major safety issues reported, suggesting it might also be safe for children undergoing similar surgeries. Dexamethasone, the main ingredient in DEXYCU, is a steroid commonly used to reduce swelling and inflammation.

While all medications can have side effects, DEXYCU's history of use in adults and its FDA approval for reducing inflammation after cataract surgery provide reassurance about its safety. However, participating in a clinical trial always involves some risk, so discussing any concerns with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about DEXYCU because it offers a new way to manage post-surgical inflammation in childhood cataract patients. Unlike the standard treatments that often require multiple daily doses, DEXYCU is delivered as a single intraocular injection, potentially simplifying post-operative care. This unique delivery method helps ensure consistent dosing and may improve compliance, especially in young patients. Additionally, the sustained release of dexamethasone directly into the eye could lead to quicker and more effective inflammation control compared to traditional eye drops.

What evidence suggests that this trial's treatments could be effective for post-surgical inflammation in childhood cataract?

Research has shown that DEXYCU, a type of eye medication, helps reduce swelling after cataract surgery. Previous studies found that patients using this treatment experience less inflammation. In this trial, participants will receive either DEXYCU, a medicine that releases its effects slowly to control swelling more effectively after surgery, or Prednisolone acetate ophthalmic suspension as an active comparator. DEXYCU is already approved for use in adults to manage swelling after cataract surgery, demonstrating its effectiveness in similar situations. These findings suggest that DEXYCU might also help reduce swelling in children after cataract surgery. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a single injection of DEXYCU or prednisolone acetate ophthalmic suspension for 28 days

4 weeks

1 visit (in-person) for injection, followed by regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Prednisolone Acetate Ophthalmic

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

EyePoint Pharmaceuticals, Inc.

Lead Sponsor

Trials

19

Recruited

2,700+

Published Research Related to This Trial

In a study of 527 patients who received a 9% dexamethasone intraocular suspension after cataract surgery, inflammation significantly decreased, with 89.7% of eyes achieving grade 0 for anterior chamber cells by postoperative day 30.

The treatment was associated with favorable visual outcomes, as 96.6% of eyes reached target visual acuity by day 30, and adverse events were mild or moderate, indicating a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Real-World, Multicenter, Post-Marketing, Retrospective Study of Dexamethasone Intraocular Suspension for Inflammation After Cataract Surgery. Bacharach, J., McCabe, C., Jackson, M., et al.[2022]

A study involving 181 patients compared the safety and efficacy of IBI-10090 (a dropless dexamethasone injection) to prednisolone acetate eye drops after cataract surgery, finding that both treatments had similar safety profiles and effectiveness in reducing inflammation.

Patients preferred IBI-10090 due to the convenience of not needing to use eye drops, with 68.7% of IBI-10090 patients expressing strong agreement about the convenience, compared to only 39.2% of those using prednisolone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of IBI-10090 for inflammation associated with cataract surgery: Phase 3 multicenter study. Donnenfeld, ED., Solomon, KD., Matossian, C.[2019]

In a study involving 18 eyes from 9 patients, Dexycu, a single-dose intracameral steroid, was found to be effective in reducing postoperative inflammation after cataract surgery, but it was associated with a significant risk of iris atrophy, occurring in 30.7% of treated eyes.

In contrast, none of the eyes treated with standard postoperative anti-inflammatory drops developed iris atrophy, highlighting a potential safety concern with Dexycu despite its intended benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iris Atrophy After Administration of Intracameral Dexycu in Routine Cataract Surgery: A Case Series. Bergman, Z., Thompson, R., Malouf, A., et al.[2023]

The intracameral dexamethasone (ICD) drug-delivery suspension showed a significantly higher rate of anterior chamber cell (ACC) clearing at postoperative day 7 (67%) compared to daily topical corticosteroids (37%), indicating its greater efficacy in reducing postoperative inflammation after vitreoretinal surgery.

No serious ocular adverse events were reported in either treatment group up to postoperative day 90, suggesting that ICD is a safe alternative to daily corticosteroid eye drops for managing inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone intracameral drug-delivery suspension for inflammation associated with vitreoretinal surgery. Kiernan, DF.[2022]

The sustained-release dexamethasone insert (Dextenza) was evaluated in 17 children after cataract surgery, showing that only 18% of eyes had a clear anterior chamber at 1-2 weeks post-surgery, indicating limited effectiveness in reducing inflammation.

Despite some benefits, 18% of eyes experienced a spike in intraocular pressure requiring treatment, and 29% needed additional topical steroids, suggesting that while Dextenza may reduce the need for steroid drops, it does not completely eliminate the need for further intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sustained-release intracanalicular dexamethasone insert (Dextenza) for pediatric cataract surgery. Trivedi, RH., Wilson, ME.[2021]

DEXYCU (dexamethasone intraocular suspension) 9% is the first FDA-approved intraocular corticosteroid for controlling postoperative inflammation, offering a sustained-release formulation that ensures effective drug delivery directly to the surgical site.

This method of administration allows for better control by the surgeon, minimizes contact with sensitive eye tissues, and potentially improves patient outcomes compared to traditional eye drop methods that rely on patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Experience with Intracapsular Administration of Dexamethasone Intraocular Suspension 9% for Control of Postoperative Inflammation. McCabe, C., Desai, P., Nijm, L., et al.[2022]

In a study of 189 eyes from 180 patients undergoing cataract surgery, the combination of diclofenac (DICL) and preservative-free dexamethasone (DEX) was found to be more effective than DEX alone in reducing central retinal thickness (CRT) changes and the incidence of clinically significant pseudophakic cystoid macular edema (PCME).

DICL alone was superior to DEX in minimizing CRT increase and had a lower incidence of ocular symptoms (37% for DICL vs. 11% for DEX), suggesting that DICL may be a safer option for postoperative inflammation management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-inflammatory medication following cataract surgery: a randomized trial between preservative-free dexamethasone, diclofenac and their combination. Ylinen, P., Holmström, E., Laine, I., et al.[2018]

A single intracameral injection of triamcinolone acetonide during pediatric traumatic cataract surgery significantly reduced postoperative inflammation, as evidenced by the absence of fibrinous anterior chamber reactions in the treatment group compared to 15% in the control group.

The study, involving 40 eyes of children aged around 6 years, showed that the use of triamcinolone also prevented visual axis obscuration, which occurred in 15% of the control group, highlighting its efficacy in improving postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intracameral triamcinolone acetonide on postoperative intraocular inflammation in pediatric traumatic cataract. Mohamed, TA., Soliman, W., Fathalla, AM.[2018]

Citations

1. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2018/208912Orig1s000SumR.pdf

208912Orig1s000 - accessdata.fda.gov The potential benefits of Dexycu (dexamethasone intraocular suspension) 0.9% through reduction of postoperative inflammation outweigh the.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05191706?term=AREA%5BInterventionSearch%5D(DEXYCU)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=4

Evaluate the Safety of DEXYCU for the Treatment ... Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract. ClinicalTrials.gov ID NCT05191706. Sponsor ...

3. molinahealthcare.com molinahealthcare.com/-/media/Molina/PublicWebsite/PDF/Providers/common/pa-criteria/Dexycu-dexamethasone-intraocular-suspension-C16320-A.pdf

Dexycu (dexamethasone intraocular suspension) C16320-A The comparative efficacy and safety of topical non-steroidal anti-inflammatory drugs for the treatment of anterior chamber inflammation after ...

4. ophthalmology360.com ophthalmology360.com/cataract/study-positive-outcomes-dexamethasone-intraocular-suspension-after-cataract-surgery/

Study: Positive outcomes with dexamethasone intraocular ... Data were collected from records of patients who received dexamethasone intraocular suspension 9% after cataract surgery between March 12 and December 15, 2019.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10401390/

Use and Cost of Sustained-Release Corticosteroids for ... This cross-sectional study examines the use and cost of sustained-release corticosteroids for cataract surgery within the Medicare pass-through program.

6. eyepointpharma.com eyepointpharma.com/downloads/202202-dexycu-pi.pdf

202202-dexycu-pi.pdf The patients received a single intraocular injection of DEXYCU containing 342 mcg or 517 mcg of dexamethasone at the end of cataract surgery and blood samples ...

7. molinahealthcare.com molinahealthcare.com/~/media/Molina/PublicWebsite/PDF/Common/April2023/Dexycu_dexamethasone-intraocular-suspension_R.pdf

Molina Clinical Policy Dexycu (dexamethasone intraocular ... Post-Operative Inflammation Following Cataract Surgery. An estimated 3.7 million cataract surgeries were performed annually in the United States ...