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

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Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: Baylor Research Institute | N=200 ➔ 0 | Not yet recruiting ➔ Withdrawn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

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 2025 ➔ Jan 2026 | Recruiting ➔ Suspended | Trial primary completion date: Jan 2025 ➔ Jan 2026

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

DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Lejla Vajzovic, MD, FASRS | Trial completion date: Apr 2024 ➔ Apr 2025 | Trial primary completion date: Apr 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Anesthesia • Pediatrics • Retinal Disorders

Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED) (clinicaltrials.gov) - P4 | N=54 | Terminated | Sponsor: Tufts Medical Center | Recruiting ➔ Terminated; Per sponsor decision due to lengthy enrollment period

Trial termination • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery (clinicaltrials.gov) - P4 | N=50 | Active, not recruiting | Sponsor: Nicole Fram M.D. | Recruiting ➔ Active, not recruiting | N=100 ➔ 50 | Trial completion date: Jun 2024 ➔ Apr 2025 | Trial primary completion date: Jun 2024 ➔ Apr 2025

Enrollment change • Enrollment closed • Surgery • Trial completion date • Trial primary completion date • Cataract • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Pain

The Efficacy and Safety of Dexamethasone Intracanalicular Insert Use in Patients with Chronic Seasonal/Perennial Allergic Conjunctivitis: A Systematic Review and Meta-Analysis. (PubMed, Clin Ophthalmol) - "The pooled analysis showed no significant difference (P = 0.57, I2 = 0%) between the DEXTENZA and placebo groups in the frequency of adverse events. DEXTENZA has emerged as a promising and viable treatment option for patients with seasonal/perennial allergic conjunctivitis and is an effective alternative to current therapeutic modalities."

Journal • Retrospective data • Review • Conjunctivitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Xen Trimming to Achieve Lower IOP (AAO 2024) - "I propose a technique that can minimize tenon formation and further reduce postoperative IOP by trimming the Xen implant prior to ab interno implantation and performing primary needling of the subconjunctival portion. To further help prevent encapsulation, I add a dexamethasone ophthalmic insert (Dextenza) to supplement the postoperative steroid regimen so the eye can have some nocturnal steroid coverage."

Glaucoma • Ophthalmology

Postoperative Inflammation Following Intracanalicular Dexamethasone Insert Use in Cataract Surgery With and Without MIGS (AAO 2024) - "Conclusion Dextenza is effective at controlling postoperative inflammation, both in the literature and in this study. Rates were also similar between phaco and phaco-MIGS, demonstrating the viability of Dextenza use in MIGS cases."

Surgery • Cataract • Glaucoma • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Dextenza in the Post-op Management of Vitreoretinal Surgeries (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: The Cleveland Clinic | Enrolling by invitation ➔ Recruiting | Trial completion date: Jun 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Enrollment status • Surgery • Trial completion date • Trial primary completion date • Inflammation • Ocular Inflammation • Pain