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
Patient Preference	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

Trials by Country for DEXTENZA
Location	Trials
United States	42

Trials by US State

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

Clinical Trial Progress for DEXTENZA

Clinical Trial Phase

Clinical Trial Phase for DEXTENZA
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	41
Phase 3	1

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	42
Industry	24
U.S. Fed	1

Last updated: July 27, 2026

DEXTENZA clinical trials update, market analysis, and projection (dexamethasone insert)

DEXTENZA (dexamethasone ophthalmic insert) is an FDA-approved perioperative/postoperative corticosteroid for ocular inflammation. Market expansion depends on (1) continued site-of-care adoption in cataract and other ophthalmic surgery settings, (2) payer coverage stability for the insert format, and (3) competitive pressure from existing generic steroid drops and sustained-release competitors. A forward market view is therefore driven less by “new molecular entrants” and more by conversion of surgeons and ASCs/eye clinics to an insert-based pathway versus drops.

However, no complete, verifiable clinical-trials update set, current enrollment status, or monetizable market sizing/projection figures can be produced from the information available in this session.

What is the latest DEXTENZA clinical trials status and what endpoints are being updated?

Answer: This requires an up-to-date registry-backed scan (ClinicalTrials.gov and major regional registries) tied to specific NCT identifiers, recruiting/completed status, and readouts. Those inputs are not provided here, so a complete and accurate “latest status and endpoints” update cannot be generated.

Which NCT trials test DEXTENZA and what are their phases?

Answer: Not determinable without NCT-level data (trial title, sponsor, phase, start/completion dates, arms, and primary endpoints).

Are there Phase 3 studies supporting new indications (non-cataract) for DEXTENZA?

Answer: Not determinable without current trial registry search results.

Are trials exploring dose duration, insert size, or combination regimens?

Answer: Not determinable without protocol and supplement-level data.

How big is the DEXTENZA market and what segment drives revenue (cataract, post-op inflammation, glaucoma surgery)?

Answer: A quantitative market analysis requires current IMS/IQVIA-style category figures, channel mix, and procedure volumes. Those inputs are not available in this session, so no defensible market sizing or segment share can be stated.

What is DEXTENZA’s payer and site-of-care footprint?

Answer: Not determinable without claims/coverage datasets.

How does DEXTENZA adoption differ between ophthalmology practices and ambulatory surgery centers?

Answer: Not determinable without provider panel and admin/dispensing data.

What are the main demand drivers: surgical procedure volume or switching from steroid drops?

Answer: Not determinable without historical pull-through data and competitive conversion studies.

When does DEXTENZA face competition from generics or sustained-release alternatives?

Answer: Competition timing depends on patent and exclusivity status for the insert format, formulation/manufacturing IP, and any FDA regulatory-path transitions for generic or copy products. This requires current Orange Book and patent estate verification, which is not provided here.

Will DEXTENZA lose exclusivity soon, and what filings create generic entry risk?

Answer: Not determinable without Orange Book, patent expiration dates, and Paragraph IV/PTR/505(b)(2) filing data.

Which sustained-release ophthalmic steroid products compete with DEXTENZA?

Answer: Not determinable without a current competitive landscape list including approvals, label overlap, and evidence of comparative effectiveness.

How does DEXTENZA compare with dexamethasone eye drops and other corticosteroid regimens for post-op ocular inflammation?

Answer: A defensible clinical comparison needs head-to-head trials, meta-analyses, and outcome definitions (anterior chamber inflammation grading, IOP effects, adherence outcomes). Those data are not provided here, so no accurate comparative effectiveness claims can be made.

Does DEXTENZA reduce dosing frequency and improve adherence vs drops?

Answer: Not determinable without trial or real-world adherence evidence.

What safety differences matter in real-world practice (IOP rise, infection risk, steroid response)?

Answer: Not determinable without safety datasets and labeling review.

What are the top clinical and commercial risks affecting DEXTENZA projections?

Answer: A complete risk register requires current trial status, competitive penetration metrics, reimbursement dynamics, and regulatory/patent timing. None of those are available here in a way that supports a complete, accurate projection.

Regulatory risk

Answer: Not determinable without current FDA labeling changes, postmarketing commitments, or agency communications.

Patent/IP risk

Answer: Not determinable without current Orange Book verification and litigation status.

Market execution risk

Answer: Not determinable without sales history, gross-to-net pressures, and payer policies.

DEXTENZA forecast: revenue projection scenarios for 2026–2031

Answer: Producing numeric 2026–2031 projections requires baseline revenue, adoption curves, competitive entry assumptions, and procedure volume forecasts. Those inputs are not provided here, so projections would be speculative.

Base case vs upside vs downside scenario drivers

Answer: Not determinable without market baseline and competitor/entry timelines.

Key KPI model inputs that must be tracked

Answer: Not determinable without access to current KPI baselines (TRx, claims, NBRx, mix, persistency, and reimbursement).

Key Takeaways

• DEXTENZA is an FDA-approved dexamethasone ophthalmic insert for postoperative/perioperative ocular inflammation, with commercial performance tied to adoption versus steroid drops and competitive sustained-release options.
• A clinical trials update and a numeric market forecast require registry-backed trial status and current market sizing/procedure and payer data. Those inputs are not available in this session, so no complete, accurate update or projection can be produced.

FAQs

1. What is DEXTENZA’s FDA-approved indication and dosing schedule for the dexamethasone insert?
2. Are there any active ClinicalTrials.gov studies for DEXTENZA in additional ophthalmic surgery settings?
3. Is there Orange Book listing for DEXTENZA patents and what is the earliest potential generic entry date?
4. What outcomes matter most in DEXTENZA efficacy claims versus steroid eye drops (AC inflammation grading, adherence, IOP)?
5. How do reimbursement policies and copay design affect DEXTENZA uptake in ophthalmology practices?

References

(No sources cited because no extractable, verifiable registry, Orange Book, FDA, or market datasets were provided in this session.)