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

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

The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study (clinicaltrials.gov) - P4 | N=20 | Completed | Sponsor: Vance Thompson Vision | Phase classification: P=N/A ➔ P4

Phase classification • Inflammation • Ocular Inflammation • Pain

Evaluating a Sustained-Release Dexamethasone Insert as Adjunctive Therapy for Inflammation and Pain Post-Corneal Transplantation. (PubMed, Clin Ophthalmol) - "There were no statistically significant differences in pain, delayed re-epithelialization, IOP elevation, corneal rejection, or CME between the Dextenza and control groups regardless of the type of corneal transplantation performed. Dextenza, when combined with a lower-frequency drop regimen, demonstrates a safety profile comparable to that of a traditional higher-frequency drop protocol in terms of pain management and the adverse events explored in this study, potentially enhancing postoperative drop adherence."

Clinical • Journal • Inflammation • Macular Edema • Ophthalmology • Pain • Transplantation

Early Real-World Patient and Staff Experience with an Intracanalicular Dexamethasone Insert. (PubMed, Clin Ophthalmol) - "To evaluate both the early experience of real-world patients treated with dexamethasone ophthalmic insert (0.4 mg; DEXTENZA®), hereafter referred to as DEX, after cataract surgery as well as staff/practice integration of DEX relative to eyedrops...Most practice staff (95%) were satisfied or highly satisfied with DEX, reporting a 45% reduction in time spent educating patients on postoperative drop use and a 46% decrease in time spent addressing calls from pharmacies regarding postoperative medications. Incorporating the DEX insert into clinical practice in cataract surgery practices can improve patient adherence, while potentially providing significant savings to practices in terms of time spent educating patients and responding to patient and pharmacy call-backs."

Journal • Real-world • Real-world evidence • Cataract • Inflammation • Ocular Inflammation • Ophthalmology • Pain

Safety of intracanalicular Dexamethasone Ophthalmic Inserts combined with topical Ketorolac tromethamine 0.5% for the management of post-operative inflammation after cataract surgery in patients at increased risk of cystoid macular edema. (ARVO 2024) - "After cataract surgery, IDOI/ketorolac shows slightly higher rates of rebound inflammation than PA/ketorolac regimen with no significant differences in CME rates or in IOP increase frequency; however, overall, the rate of postoperative complications was low. IDOI can be a safe and effective alternative to topical corticosteroid therapy after cataract surgery when combined with a non-steroidal agent in patients susceptible to an increased inflammatory response due to pre-existing ocular comorbidities. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

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

Dextenza for Corneal Crosslinking (clinicaltrials.gov) - P1/2 | N=20 | Enrolling by invitation | Sponsor: Maanasa Indaram, MD | Initiation date: Jan 2024 ➔ Apr 2024

Trial initiation date • Ophthalmology

A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract (clinicaltrials.gov) - P3 | N=65 | Completed | Sponsor: Ocular Therapeutix, Inc. | Recruiting ➔ Completed | Trial completion date: Oct 2022 ➔ Dec 2023 | Trial primary completion date: Aug 2022 ➔ Dec 2023

Surgery • Trial completion • Trial completion date • Trial primary completion date • Cataract • Inflammation • Ocular Inflammation • Ophthalmology • Pain • Pediatrics

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 | Phase classification: P2b ➔ P2 | Trial completion date: Jan 2024 ➔ Jan 2025 | Trial primary completion date: Jan 2024 ➔ Jan 2025

Combination therapy • Phase classification • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

DEXTENZA versus Topical Steroid or Antihistamine Therapy for Treatment of Allergic Conjunctivitis. (PubMed, Clin Ophthalmol) - "To compare clinical outcomes and patient preference for the dexamethasone intracanalicular insert (DEX) versus topical loteprednol (LOT) or olopatadine (OLO) for the treatment of allergic conjunctivitis in a real-world model of allergen exposure. Overall, this real-world study demonstrated that the dexamethasone intracanalicular insert was as effective as a topical antihistamine/mast cell stabilizer and more effective than topical steroids in relieving the signs and symptoms of allergic conjunctivitis. This insert should be considered as an alternative to topical therapy for the treatment of allergic conjunctivitis."

Clinical • Conjunctivitis • Ocular Infections • Ocular Inflammation • Ophthalmology

AffaMed Therapeutics Announces New Drug Application Acceptance by Singapore Health Sciences Authority (HSA) for DEXTENZA for Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery, and Ocular Itching Associated with Allergic Conjunctivitis (PRNewswire) - "AffaMed Therapeutics...announced that the Singapore Health Sciences Authority (HSA) has accepted its New Drug Application (NDA) for DEXTENZA (0.4 mg dexamethasone ophthalmic insert) for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis. DEXTENZA is approved in the U.S. and listed in Macau for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis."

Non-US regulatory • Conjunctivitis • Ocular Inflammation • Ophthalmology • Pain

SUSTAIN: Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery (clinicaltrials.gov) - P4 | N=25 | Terminated | Sponsor: The New York Eye Surgery Center | Completed ➔ Terminated; COVID-19 challenges to recruitment

Surgery • Trial termination • Cataract • Glaucoma • Ophthalmology