Dextenza (dexamethasone ophthalmic insert) / Ocular Therapeutix - LARVOL DELTA

A Study of Selinexor, in Combination With Carfilzomib, Daratumumab or Pomalidomide in Patients With Multiple Myeloma (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Hackensack Meridian Health | Suspended ➔ Recruiting | Trial completion date: Feb 2027 ➔ Feb 2028 | Trial primary completion date: Feb 2027 ➔ Feb 2028

Enrollment open • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Dextenza Versus Topical Steroid Eye Drops for Postoperative Management Following Corneal Crosslinking (clinicaltrials.gov) - P1/2 | N=20 | Enrolling by invitation | Sponsor: Maanasa Indaram, MD | Trial completion date: Dec 2026 ➔ Jul 2027 | Trial primary completion date: Aug 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Ophthalmology

LODEXA: Low Dose Dexamethasone for the Prevention of Cytokine Release Syndrome Associated With Tebentafusp (clinicaltrials.gov) - P2 | N=34 | Not yet recruiting | Sponsor: University of California, San Diego

New P2 trial • Eye Cancer • Inflammation • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Dextenza in the Post-op Management of Vitreoretinal Surgeries (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: The Cleveland Clinic | Trial completion date: May 2026 ➔ Dec 2027 | Trial primary completion date: May 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Inflammation • Ocular Inflammation • Pain

Punctal and Intracanalicular Drug Delivery Systems for Ophthalmic Use: A Narrative Review of Technologies, Clinical Outcomes, and Critical Quality Attributes. (PubMed, Pharmaceutics) - "DEXTENZA® (dexamethasone) is FDA-approved for postoperative inflammation, whereas pivotal trials of travoprost (OTX-TP) and latanoprost systems (L-PPDS, EXP-LP) did not demonstrate superiority over placebo or eye drops. We propose the following candidate CQAs: retention (>80% over 4 weeks), swelling degree (30-60%), controlled burst release (<40% within 24 h), and mechanical compatibility. The proposed QTPP matrices for punctal, intracanalicular, and in situ systems may guide the development of ophthalmic drug delivery platforms."

Clinical data • Journal • Review • Inflammation • Ocular Inflammation • Ophthalmology

Tear Pharmacokinetics and Systemic Exposure of Dexamethasone Canalicular Inserts in Rabbits (ARVO 2026) - "Purpose A dexamethasone canalicular insert, Dextenza®, has been used to treat anterior inflammation of the eye, including keratoconjunctivitis sicca...The in vitro dissolution pattern represented an excellent correlation with the in vivo release in tears. Conclusions We first examined the pharmacokinetic study of the canalicular insert in rabbits, which could be applied to the other insert studies in the species."

PK/PD data • Preclinical • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

Safety and Efficacy of Sustained-Release Dexamethasone Intracanalicular Insert in Pediatric Retinal Procedures (ARVO 2026) - "This prospective, randomized clinical study evaluates the safety and efficacy of a sustained-release dexamethasone intracanalicular insert (Dextenza, Ocular Therapeutix, Inc.) as a novel alternative to steroid drops in pediatric patients undergoing retinal procedures...By removing the need for frequent eye drop administration, the implant may make recovery less distressing while maintaining sufficient control of inflammation and discomfort. Our findings suggest that this insert is a safe and effective alternative to traditional steroid drops in kids after retinal procedures, offering a simpler, lower-stress recovery experience for children and families."

Clinical • Ophthalmology

Subconjunctival Triamcinolone Acetonide Injection Compared with Dexamethasone Ophthalmic Insert for Inflammation Prophylaxis After Cataract Surgery: A Comparative Clinical Study. (PubMed, Clin Ophthalmol) - "However, post-operative complications were low, with no significant differences in the rates of rebound iritis or CME between the two groups. STAI and DII have similar clinical utility in the prophylaxis of inflammation after cataract surgery."

Journal • Cataract • Glaucoma • Infectious Disease • Inflammation • Macular Edema • Ocular Infections • Ocular Inflammation • Ophthalmology • Uveitis

Dextenza Versus Topical Steroid Eye Drops for Postoperative Management Following Corneal Crosslinking (clinicaltrials.gov) - P1/2 | N=20 | Enrolling by invitation | Sponsor: Maanasa Indaram, MD | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Ophthalmology

Management of Post-Operative Inflammation After Cataract Surgery with Intracanalicular Dexamethasone Implant and Topical Ketorolac. (PubMed, Clin Ophthalmol) - "To determine the safety of an intracanalicular dexamethasone ophthalmic insert (IDOI) and topical Ketorolac tromethamine 0.5% (ketorolac) versus ketorolac and topical prednisolone acetate 1% (PA) over the first month after cataract surgery (POM1). There was no difference in the rate of rebound inflammation or CME in the IDOI/ketorolac regimen compared to the PA/ketorolac regimen. IDOI can be a safe and effective dropless alternative to PA/ketorolac therapy after cataract surgery in patients susceptible to inflammation."

Journal • Cataract • Diabetic Retinopathy • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: Baylor Research Institute | N=200 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Cataract • Diabetes • Metabolic Disorders • Ophthalmology

A Study of Selinexor, in Combination With Carfilzomib, Daratumumab or Pomalidomide in Patients With Multiple Myeloma (clinicaltrials.gov) - P2 | N=96 | Suspended | Sponsor: Hackensack Meridian Health | Trial completion date: Jan 2026 ➔ Feb 2027 | Trial primary completion date: Jan 2026 ➔ Feb 2027

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Dextenza in the Post-op Management of Vitreoretinal Surgeries (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: The Cleveland Clinic | Trial completion date: Dec 2025 ➔ May 2026 | Trial primary completion date: Dec 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Inflammation • Ocular Inflammation • Pain

Formulary in Focus: Are We Seeing Eye to Eye on Dextenza? (ASHP 2025) - No abstract available

Hydrogel-based ocular drug delivery systems. (PubMed, J Mater Chem B) - "Significant advances highlight the controlled release, mucoadhesion, and biocompatibility of hydrogels, which allow prolonged drug delivery as demonstrated by commercial products such as DEXTENZA® and ReSure® Sealant for corneal sealing and post-operative inflammation control...Hydrogels exhibit considerable promise for personal and least invasive treatments, despite challenges like scalability and high production costs. With implications for improving clinical outcomes and patient compliance through novel biomaterials, this review highlights the important role of hydrogels in ocular drug delivery and offers an outline for future advancements in the treatment of diseases like glaucoma, age-related macular degeneration, and dry eye syndrome."

Journal • Review • Age-related Macular Degeneration • Dry Eye Disease • Glaucoma • Inflammation • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery (clinicaltrials.gov) - P4 | N=50 | Completed | Sponsor: Nicole Fram M.D. | Active, not recruiting ➔ Completed

Trial completion • Cataract • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Pain

DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Lejla Vajzovic, MD, FASRS | N=30 ➔ 16 | Recruiting ➔ Completed

Enrollment change • Trial completion • Anesthesia • Pediatrics • Retinal Disorders

Tear Pharmacokinetics and Systemic Exposure of Dexamethasone Canalicular Inserts in Rabbits. (PubMed, J Ocul Pharmacol Ther) - "Purpose: A dexamethasone canalicular insert, Dextenza®, has been used to treat anterior inflammation of the eye, including keratoconjunctivitis sicca...The in vitro dissolution pattern represented an excellent correlation with the in vivo release in tears. We first examined the pharmacokinetic study of the canalicular insert in rabbits, which could be applied to the other insert studies in the species."

Journal • PK/PD data • Preclinical • Conjunctivitis • Dry Eye Disease • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

The safety and efficacy of intra-canalicular dexamethasone insert for ocular pain and inflammation management post-cataract surgery: a systematic review and meta-analysis of randomized controlled trials. (PubMed, Int Ophthalmol) - "Adverse events, including non-serious and serious ocular incidents, were lower in the DEXTENZA group (RR = 0.57, 95% CI = 0.42-0.78, P = 0.0005). The sustained-release mechanism of DEXTENZA improves adherence and may offer practical advantages in postoperative management, particularly in patients with challenges using topical drops these findings support the use of intracanalicular corticosteroids as a promising alternative for managing postoperative pain and inflammation in cataract surgery patients."

Clinical • Journal • Retrospective data • Review • Cataract • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Pain

Dextenza Versus Topical Steroid Eye Drops for Postoperative Management Following Corneal Crosslinking (clinicaltrials.gov) - P1/2 | N=20 | Enrolling by invitation | Sponsor: Maanasa Indaram, MD | Trial completion date: Dec 2024 ➔ Jun 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Ophthalmology

PERSIST: Dextenza for Post-operative Treatment of Pterygium (clinicaltrials.gov) - P4 | N=20 | Completed | Sponsor: Brandon Eye Associates, PA | Active, not recruiting ➔ Completed

Trial completion • Inflammation • Ophthalmology • Pain

Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Illinois College of Optometry | N=18 ➔ 36

Enrollment change • Allergy • Conjunctivitis • Dry Eye Disease • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Treatment of allergic rhinitis and allergic conjunctivitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Allergic Rhinitis • Allergy • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Safety and Efficacy of Intracanalicular Dexamethasone Inserts for the Control of Inflammation and Discomfort in Dry Eye disease (DECIDED) - A Randomized, Sham-Controlled Trial (ARVO 2025) - "Purpose Determine the safety and efficacy of intracanalicular dexamethasone insert (IDI) for dry eye disease (DED) Methods A prospective, single center, randomized sham-controlled, double-masked trial was performed in DED patients, randomized 1:1 to IDI treatment (dexamethasone ophthalmic insert 0.4mg) or 0.5 mm collagen plugs as controls and followed at 4 weeks...Steroids are an effective treatment for DED. IDI is a novel treatment modality for DED that eliminates the requirement of frequent drop instilation, which can cause discomfort and blurring of vision and can result in poor compliance."

Clinical • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Ocular Therapeutix Reports Fourth Quarter and Full Year 2024 Results and Business Highlights (GlobeNewswire) - "Total net revenue was $17.1 million for the fourth quarter of 2024, a 15.4% increase over total net revenue of $14.8 million in the comparable quarter in 2023. Total net revenue for the full year 2024 was $63.7 million versus $58.4 million in 2023, an increase of 9.0%. This increase was driven by increased gross revenues from DEXTENZA sales, partially offset by higher gross-to-net provisions in the 2024 period compared to the prior year."

Commercial • Ocular Inflammation • Ophthalmology • Pain