CLINICAL TRIALS PROFILE FOR DEXYCU KIT

All Clinical Trials for dexycu kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02006888 ↗	The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery	Completed	ICON Bioscience Inc	Phase 3	2014-01-01	The purpose of this study is to determine whether IBI-10090 injection is effective in the treatment of inflammation associated with cataract surgery.
NCT02547623 ↗	Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery	Completed	ICON Bioscience Inc	Phase 3	2015-11-06	The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups - A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or; - Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.
NCT04184999 ↗	Effect of Intraoperative Dexamethasone on Post-op Dry Eye	Completed	SR Cornea Consultants	Phase 4	2019-08-10	To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen.
NCT04273282 ↗	A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%	Completed	MDbackline, LLC	Phase 4	2019-12-16	This is a post-approval, open-label, randomized, self-controlled prospective clinical study to evaluate the safety and ocular efficacy of Dexycu in controlling postoperative ocular pain and inflammation associated with cataract surgery.
NCT04273282 ↗	A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%	Completed	Research Insight LLC	Phase 4	2019-12-16	This is a post-approval, open-label, randomized, self-controlled prospective clinical study to evaluate the safety and ocular efficacy of Dexycu in controlling postoperative ocular pain and inflammation associated with cataract surgery.
NCT04316936 ↗	Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery	Recruiting	Ocular Therapeutix, Inc.	Phase 4	2019-12-10	This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.

Clinical Trial Conditions for dexycu kit

Condition Name

Condition Name for dexycu kit
Intervention	Trials
Cataract	6
Inflammation	1
Relapsed and Refractory Multiple Myeloma	1
Cataract Surgery	1

Condition MeSH

Condition MeSH for dexycu kit
Intervention	Trials
Cataract	8
Inflammation	4
Neoplasms, Plasma Cell	1
Multiple Myeloma	1

Clinical Trial Locations for dexycu kit

Trials by Country

Trials by Country for dexycu kit
Location	Trials
United States	17

Trials by US State

Trials by US State for dexycu kit
Location	Trials
California	4
Florida	2
South Carolina	2
New York	2
Missouri	1

Clinical Trial Progress for dexycu kit

Clinical Trial Phase

Clinical Trial Phase for dexycu kit
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for dexycu kit
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	3
Recruiting	3

Clinical Trial Sponsors for dexycu kit

Sponsor Name

Sponsor Name for dexycu kit
Sponsor	Trials
EyePoint Pharmaceuticals, Inc.	4
ICON Bioscience Inc	2
University of Miami	1

Sponsor Type

Sponsor Type for dexycu kit
Sponsor	Trials
Industry	9
Other	5

Dexycu kit Market Analysis and Financial Projection

Dexycu Kit: Clinical Trials, Market Analysis, and Projections

Introduction to Dexycu Kit

Dexycu Kit, developed by EyePoint Pharmaceuticals, Inc., is a groundbreaking ophthalmic product that has revolutionized the treatment of postoperative inflammation following cataract surgery. It is the first and only FDA-approved intraocular steroid for this indication, administered as a single dose at the end of the surgery.

Clinical Trials Overview

Efficacy and Safety

The approval of Dexycu Kit was based on several clinical trials, notably the Study C13-04, which was an adequate and well-controlled study. This study demonstrated that Dexycu, in doses of 342 mcg and 517 mcg, was superior to placebo in clearing anterior chamber cells after cataract surgery. The superiority was evident from day 3 post-surgery and continued through day 30[1][2].

Key Findings

• The percentage of patients meeting the primary efficacy outcome was significantly higher in the Dexycu treatment groups (57% and 60% for the 342 mcg and 517 mcg groups, respectively) compared to the placebo group (20%)[2].
• The need for rescue medication, such as ocular steroids or nonsteroidal anti-inflammatory drugs, was significantly lower in the Dexycu treatment groups at various time points post-surgery[2].

Adverse Reactions

Common adverse reactions associated with Dexycu included increased intraocular pressure (IOP), corneal edema, and iritis. Less common adverse reactions included corneal endothelial cell loss, blepharitis, eye pain, and cystoid macular edema[2].

Market Analysis

Launch and Commercialization

Dexycu Kit was commercially launched in the U.S. in March 2019, with a primary focus on its use following cataract surgery. This launch marked a significant shift from the traditional standard of care, which involved multiple daily doses of steroid, antibiotic, and non-steroidal eye drops over several weeks[3][5].

Market Potential

Given that approximately 3.8 million cataract surgeries are performed annually in the U.S., the market potential for Dexycu Kit is substantial. The convenience of a single intraocular injection, combined with its efficacy and the reduction in the need for postoperative eye drops, positions Dexycu Kit as a preferred option for both surgeons and patients[3].

Competitive Landscape

Dexycu Kit's proprietary Verisome® drug-delivery technology, which allows for the sustained release of dexamethasone over up to 22 days, sets it apart from other treatments. This technology ensures a consistent and prolonged therapeutic effect, enhancing patient compliance and outcomes[3].

Market Projections

Sales and Revenue

EyePoint Pharmaceuticals has been actively promoting Dexycu Kit, and the product has seen significant uptake since its launch. The company's focus on establishing a robust commercial infrastructure and entering into commercial agreements is expected to drive sales and revenue growth. With its unique value proposition, Dexycu Kit is projected to capture a significant share of the postoperative ocular inflammation treatment market[3][5].

Growth Drivers

• Increasing Number of Cataract Surgeries: The rising number of cataract surgeries, driven by an aging population and improved healthcare access, will continue to drive demand for Dexycu Kit.
• Clinical Efficacy and Convenience: The proven efficacy and convenience of a single-dose treatment will attract more surgeons and patients, further boosting market penetration.
• Expanding Healthcare Coverage: As more insurance providers cover Dexycu Kit, accessibility and adoption rates are expected to increase[3].

Patent and Regulatory Landscape

Patent Protection

Dexycu Kit is protected by five U.S. patents and 45 international patent families, ensuring exclusivity for EyePoint Pharmaceuticals for a considerable period. This patent protection will help in maintaining market dominance and preventing early generic competition[4].

Regulatory Compliance

The FDA approval of Dexycu Kit has been a critical milestone. EyePoint Pharmaceuticals continues to work closely with regulatory bodies to ensure compliance and to explore potential extensions of the product's indications and uses[1][5].

Key Takeaways

• Clinical Efficacy: Dexycu Kit has demonstrated superior efficacy in clearing anterior chamber cells post-cataract surgery compared to placebo.
• Market Potential: With millions of cataract surgeries performed annually, Dexycu Kit has a significant market potential.
• Unique Technology: The Verisome® drug-delivery platform provides a sustained release of dexamethasone, enhancing patient compliance and outcomes.
• Growth Drivers: Increasing cataract surgeries, clinical efficacy, convenience, and expanding healthcare coverage are key drivers for growth.
• Patent Protection: Dexycu Kit is protected by multiple patents, ensuring market exclusivity.

FAQs

What is Dexycu Kit used for?

Dexycu Kit is used for the treatment of postoperative inflammation following cataract surgery.

How is Dexycu Kit administered?

Dexycu Kit is administered as a single intraocular injection at the end of cataract surgery.

What are the common adverse reactions associated with Dexycu Kit?

Common adverse reactions include increased intraocular pressure (IOP), corneal edema, and iritis.

How long does the therapeutic effect of Dexycu Kit last?

The therapeutic effect of Dexycu Kit lasts for up to 22 days due to its proprietary Verisome® drug-delivery technology.

When was Dexycu Kit commercially launched in the U.S.?

Dexycu Kit was commercially launched in the U.S. in March 2019.

Sources

1. FDA Clinical Review: "NDA 208-912 Dexycu (dexamethasone intraocular suspension)".
2. EyePoint Pharmaceuticals, Inc.: "DEXYCU Utilizes Proprietary Verisome® Drug-Delivery Platform".
3. EyePoint Pharmaceuticals, Inc.: "Commercialization of DEXYCU in the U.S."
4. Drug Patent Watch: "DEXYCU KIT".
5. PR Newswire: "U.S. Commercialization of DEXYCU".