CLINICAL TRIALS PROFILE FOR DEXTENZA

505(b)(2) Clinical Trials for DEXTENZA

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT04237012 ↗	ACCURATE Study for Subjects With Dry Eyes	Recruiting	The Eye Centers of Racine and Kenosha	Phase 4	2019-12-16	To determine treatment and imaging outcomes in bilateral ocular surface disease management with an intracanalicular dexamethasone (0.4 mg) insert compared to standard topical over-the-counter artificial tears lubrication management

All Clinical Trials for DEXTENZA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04168112 ↗	Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study	Active, not recruiting	Ocular Therapeutix, Inc.	Phase 4	2020-02-12	There is no standard of care medication regimen for the management of pain and inflammation post-corneal crosslinking (CXL), although most cornea specialists agree on use of an antibiotic and steroid eye drop in the immediate postoperative period. However, steroid tapering schedule and use of additional topical non-steroidal anti-inflammatory (NSAID) eyedrops vary amongst practitioners. The goal of this study is to compare postoperative pain scores between patients receiving a tapering dose of topical steroids over 1-month post-CXL, versus those receiving an intracanalicular dexamethasone insert.
NCT04168112 ↗	Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study	Active, not recruiting	Sight Medical Doctors PLLC	Phase 4	2020-02-12	There is no standard of care medication regimen for the management of pain and inflammation post-corneal crosslinking (CXL), although most cornea specialists agree on use of an antibiotic and steroid eye drop in the immediate postoperative period. However, steroid tapering schedule and use of additional topical non-steroidal anti-inflammatory (NSAID) eyedrops vary amongst practitioners. The goal of this study is to compare postoperative pain scores between patients receiving a tapering dose of topical steroids over 1-month post-CXL, versus those receiving an intracanalicular dexamethasone insert.
NCT04200651 ↗	Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery	Recruiting	Ocular Therapeutix, Inc.	Phase 4	2020-01-13	In this study, the investigators are comparing dexamethasone ophthalmic insert (DEXTENZA®) to the current standard of care, prednisolone acetate 1% eye drops, in a glaucoma population receiving both cataract and minimally-invasive glaucoma surgery (MIGS). DEXTENZA® and prednisolone acetate 1% drops are both steroids used to control inflammation after eye surgery. DEXTENZA®'s method of delivery differs by offering a sustained release of steroid that does not necessitate postoperative anti-inflammatory eye drops. The investigators hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation following concomitant cataract-MIGS in a glaucoma population. The investigators also hypothesize that DEXTENZA® will be preferred by patients over prednisolone acetate 1% drops.
NCT04200651 ↗	Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery	Recruiting	The New York Eye Surgery Center	Phase 4	2020-01-13	In this study, the investigators are comparing dexamethasone ophthalmic insert (DEXTENZA®) to the current standard of care, prednisolone acetate 1% eye drops, in a glaucoma population receiving both cataract and minimally-invasive glaucoma surgery (MIGS). DEXTENZA® and prednisolone acetate 1% drops are both steroids used to control inflammation after eye surgery. DEXTENZA®'s method of delivery differs by offering a sustained release of steroid that does not necessitate postoperative anti-inflammatory eye drops. The investigators hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation following concomitant cataract-MIGS in a glaucoma population. The investigators also hypothesize that DEXTENZA® will be preferred by patients over prednisolone acetate 1% drops.

Clinical Trial Conditions for DEXTENZA

Condition Name

Condition Name for DEXTENZA
Intervention	Trials
Cataract	7
Dry Eye	4
Dry Eye Syndromes	3
Refractive Surgery	2

Condition MeSH

Condition MeSH for DEXTENZA
Intervention	Trials
Cataract	14
Inflammation	13
Keratoconjunctivitis Sicca	8
Dry Eye Syndromes	8

Clinical Trial Locations for DEXTENZA

Trials by Country

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−

Trials by Country for DEXTENZA
Location	Trials
United States	41

Trials by US State

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−

Trials by US State for DEXTENZA
Location	Trials
New York	6
California	5
Florida	5
Indiana	4
Illinois	3

Clinical Trial Progress for DEXTENZA

Clinical Trial Phase

Clinical Trial Phase for DEXTENZA
Clinical Trial Phase	Trials
Phase 4	41
Phase 3	1
Early Phase 1	3

Clinical Trial Status

Clinical Trial Status for DEXTENZA
Clinical Trial Phase	Trials
Recruiting	24
Not yet recruiting	14
Enrolling by invitation	5

Clinical Trial Sponsors for DEXTENZA

Sponsor Name

Sponsor Name for DEXTENZA
Sponsor	Trials
Ocular Therapeutix, Inc.	22
Prism Vision Group	2
Nicole Fram M.D.	2

Sponsor Type

Sponsor Type for DEXTENZA
Sponsor	Trials
Other	41
Industry	24
U.S. Fed	1

DEXTENZA: Clinical Trials, Market Analysis, and Projections

Introduction to DEXTENZA

DEXTENZA, developed by Ocular Therapeutix, is a preservative-free ophthalmic insert designed to deliver dexamethasone, a steroid, to the ocular surface. It is primarily used for the treatment of ocular inflammation and pain following ophthalmic surgery.

Clinical Trials Overview

Phase 3 Clinical Trials in the US

DEXTENZA has been studied in three Phase 3 clinical trials to evaluate its efficacy and safety in treating ocular inflammation and pain post-surgery.

• Efficacy in Reducing Ocular Pain and Inflammation: In these trials, DEXTENZA demonstrated significant efficacy. For example, in Study 1, 80% of DEXTENZA patients were pain-free by Day 8, compared to 43% of placebo patients. Similarly, in Study 3, 52% of DEXTENZA patients had absent anterior chamber cells by Day 14, compared to 31% of placebo patients[1].
• Safety Profile: The trials showed a favorable safety profile with no treatment-related serious adverse reactions. Only 0.2% of DEXTENZA patients discontinued treatment due to an adverse reaction, which was not deemed treatment-related by investigators[1].

Phase 3 Clinical Trials in China

AffaMed Therapeutics has initiated a Phase 3 registrational clinical trial in Mainland China to evaluate the efficacy and safety of DEXTENZA in treating ocular inflammation and pain following cataract surgery. This trial involves 249 subjects and is designed as a prospective, randomized, double-masked, placebo-controlled study[4].

Market Analysis

Current Market Performance

As of the third quarter of 2024, Ocular Therapeutix reported total net revenue of $15.4 million from DEXTENZA sales, representing a 2.3% increase over the same period in 2023. The company expects full-year 2024 total net revenues for DEXTENZA to be between $62.0 million and $67.0 million, up from $57.9 million in 2023[2][5].

Market Forecast

A comprehensive market analysis by ResearchAndMarkets.com projects the market dynamics for DEXTENZA up to 2032. The report highlights DEXTENZA's potential market in the United States and its impact on acute ocular pain treatments. Key aspects include:

• Sales Forecasts: The report provides detailed sales forecasts for DEXTENZA in the US, indicating a positive growth trajectory.
• SWOT Analysis: It includes a SWOT analysis to explore the strengths, weaknesses, opportunities, and threats associated with DEXTENZA in the market.
• Comparative Landscapes: The report compares DEXTENZA with emerging therapies and their market impacts, providing a comprehensive view of the competitive landscape[3].

Developmental Milestones

Ongoing and Planned Trials

• SOL-1 and SOL-R Trials: While DEXTENZA is primarily focused on post-surgical ocular inflammation and pain, Ocular Therapeutix is also conducting trials (SOL-1 and SOL-R) for other indications, such as wet age-related macular degeneration (AMD). These trials are expected to provide commercially meaningful data and support potential New Drug Application (NDA) submissions[2][5].

Regulatory Status

• FDA Approval and Guidance: The FDA has confirmed that the SOL-R trial can serve as the second adequate and well-controlled study to support a potential NDA for wet AMD. This indicates a positive regulatory environment for DEXTENZA’s expansion into new indications[2][5].

Mechanism of Action and Clinical Efficacy

How DEXTENZA Works

DEXTENZA is designed for the tapering delivery of dexamethasone to the ocular surface. This preservative-free insert alleviates symptoms of inflammation and pain by providing a sustained release of the steroid over a period of up to 30 days[3].

Clinical Efficacy

The clinical efficacy of DEXTENZA has been demonstrated through its ability to reduce ocular pain and inflammation significantly better than placebo in the Phase 3 trials. For instance, in Study 1, 80% of DEXTENZA patients were pain-free by Day 8, and in Study 3, 52% had absent anterior chamber cells by Day 14[1].

Safety Profile

Adverse Reactions

The safety profile of DEXTENZA is favorable, with no treatment-related serious adverse reactions reported in the Phase 3 trials. The most common non-ocular adverse reaction was headache, occurring in 1% of patients. Only one patient out of 538 discontinued treatment due to an adverse reaction, which was not deemed treatment-related[1].

Global Expansion

Licensing Agreements

AffaMed Therapeutics has an exclusive license agreement with Ocular Therapeutix for the development and commercialization of DEXTENZA in Greater China, South Korea, and certain ASEAN markets. This agreement is crucial for expanding DEXTENZA’s global reach[4].

Financial Outlook

Cash Reserves and Expenses

As of September 30, 2024, Ocular Therapeutix had $427.2 million in cash and cash equivalents, which is expected to be sufficient to support planned expenses and capital expenditure requirements into 2028. The company has seen an increase in research and development expenses, primarily due to the ongoing clinical trials[2][5].

Key Takeaways

• Clinical Efficacy: DEXTENZA has shown significant efficacy in reducing ocular pain and inflammation post-surgery.
• Safety Profile: The drug has a favorable safety profile with minimal adverse reactions.
• Market Growth: DEXTENZA is projected to see continued market growth, with expected revenues between $62.0 million and $67.0 million for 2024.
• Global Expansion: Licensing agreements are in place to expand DEXTENZA’s reach into new markets.
• Regulatory Support: Positive regulatory feedback supports the potential expansion of DEXTENZA into new indications.

FAQs

What is DEXTENZA used for?

DEXTENZA is used for the treatment of ocular inflammation and pain following ophthalmic surgery.

How does DEXTENZA work?

DEXTENZA is a preservative-free ophthalmic insert that delivers dexamethasone to the ocular surface, providing a sustained release of the steroid over up to 30 days.

What were the outcomes of the Phase 3 clinical trials for DEXTENZA?

In the Phase 3 trials, DEXTENZA demonstrated significant efficacy in reducing ocular pain and inflammation, with a favorable safety profile and minimal adverse reactions.

What is the current market performance of DEXTENZA?

As of the third quarter of 2024, DEXTENZA sales have shown a 2.3% increase over the same period in 2023, with projected full-year revenues between $62.0 million and $67.0 million.

Is DEXTENZA approved for use in other countries?

Yes, AffaMed Therapeutics is conducting Phase 3 trials in Mainland China and has licensing agreements for development and commercialization in Greater China, South Korea, and certain ASEAN markets.

Sources

1. Ocular Therapeutix. Ocular Inflammation and Pain Following Ophthalmic Surgery. DEXTENZA.
2. GlobeNewswire. Ocular Therapeutix Reports Third Quarter 2024 Results and Business Highlights.
3. Business Wire. Acute Ocular Pain Treatment Advances: DEXTENZA Market Forecast to 2032 --- ResearchAndMarkets.com.
4. PR Newswire. AffaMed Therapeutics Announces First Patient Treated in Phase 3 Registrational Clinical Trial in Mainland China for DEXTENZA for the Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery.
5. Ocular Therapeutix. Ocular Therapeutix Reports Third Quarter 2024 Results and Business Highlights. Investors.