Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap - LARVOL DELTA

Contralateral Randomized Comparison Between Intracameral Extended-Release Dexamethasone 9% Suspension Placed in the Capsular Bag with the Established Post-Cataract Regimen. (PubMed, Adv Ther) - "The use of intracameral dexamethasone 9% sustained-release suspension placed in the capsular bag at the time of cataract surgery seems to offer similar safety and efficacy as the established post-cataract topical regimen. Furthermore, no signs of iris atrophy were evident in any of the eyes up to 1 month post cataract surgery."

Journal • Cataract • Inflammation • Ocular Inflammation • Ophthalmology • Pain

A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: EyePoint Pharmaceuticals, Inc. | N=150 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Cataract • Ophthalmology • Pain

A Hybrid Design Incorporating External Data to Evaluate Dexamethasone Intracameral Drug Delivery Suspension for Post-Cataract Surgery Inflammation. (PubMed, Clin Pharmacol Ther) - "We conducted a proof-of-concept study to assess the feasibility and regulatory value of a hybrid Bayesian borrowing design to support a Phase III RCT of Dexamethasone Intracameral Drug-Delivery Suspension (DEXYCU) in China...This study demonstrated the feasibility and regulatory value of hybrid Bayesian designs in late-phase trials. The approach offers a practical, bias-controlled framework for integrating external data into regional drug development and regulatory decision making."

Journal • Cataract • Inflammation • Ophthalmology

Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: EyePoint Pharmaceuticals, Inc. | Trial completion date: Feb 2025 ➔ Feb 2026 | Trial primary completion date: Jan 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Cataract • Inflammation • Ocular Inflammation • Ophthalmology

Reduced Rates of Focal Iris Atrophy are Observed with Intracapsular Administration of Dexamethasone Intraocular Suspension 9% in Cataract Surgery (ARVO 2025) - "One concern with this method of drug delivery is that distortion of the iris, or the colored part of the eye, has been reported in some cases. We provide data showing that the frequency of this complication can be reduced by injecting Dexycu inside the part of the eye where a new lens is placed during cataract surgery, as opposed to injecting it behind the iris."

Surgery • Cataract • Ocular Inflammation • Ophthalmology

"A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard of Care Treatment for Post-Cataract Surgical Pain and Anterior Chamber Inflammation" (clinicaltrials.gov) - P4 | N=25 | Completed | Sponsor: The Eye Institute of West Florida | N=50 ➔ 25 | Recruiting ➔ Completed

Enrollment change • Trial completion • Cataract • Inflammation • Ophthalmology • Pain

A Real-world Study of DEXYCU in the Treatment of Inflammation After Cataract Surgery (clinicaltrials.gov) - P4 | N=263 | Completed | Sponsor: Ocumension Therapeutics (Shanghai) Co., Ltd

New P4 trial • Real-world • Real-world evidence • Surgery • Cataract • Inflammation • Ocular Inflammation • Ophthalmology

Study of Dexycu in Treating Intraocular Inflammation (clinicaltrials.gov) - P3 | N=285 | Completed | Sponsor: Ocumension Therapeutics (Shanghai) Co., Ltd

New P3 trial • Cataract • Inflammation • Ocular Inflammation • Ophthalmology

A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery (2) (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: EyePoint Pharmaceuticals, Inc. | Trial completion date: Apr 2024 ➔ Sep 2023 | Trial primary completion date: Apr 2024 ➔ Sep 2023

Surgery • Trial completion date • Trial primary completion date • Cataract • Ophthalmology • Pain

Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: EyePoint Pharmaceuticals, Inc. | Trial completion date: Feb 2024 ➔ Feb 2025 | Trial primary completion date: Jan 2024 ➔ Jan 2025

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

A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery (2) (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: EyePoint Pharmaceuticals, Inc. | N=150 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Surgery • Trial withdrawal • Cataract • Ophthalmology • Pain

Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery (clinicaltrials.gov) - P4 | N=15 | Completed | Sponsor: Silverstein Eye Centers | Unknown status ➔ Completed | N=75 ➔ 15

Enrollment change • Surgery • Trial completion • Cataract • Inflammation • Ophthalmology • Pain

SELVEDge: Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: University of Miami | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Utilization and Cost of Novel Sustained-Release Steroids for Cataract Surgery Among Medicare Beneficiaries (ASCRS-ASOA 2023) - "Purpose To examine the utilization and costs of novel sustained-release steroids, dexamethasone intraocular suspension (DEXYCU) and dexamethasone ophthalmic insert (DEXTENZA), in Medicare patients undergoing cataract surgery in the US.MethodsThis was a retrospective, cross-sectional analysis on all Medicare Fee-For-Service beneficiaries aged 65 years or older who underwent at least one cataract surgery from March 2019 to December 2021.Claims for cataract surgery and concurrent utilization of dexamethasone intraocular suspension or dexamethasone ophthalmic insert were identified by billing codes.Information on patient and surgeon demographic characteristics and cost of surgery and drugs were extracted to determine the utilization rate and cost.A hierarchical multivariable logistic regression model was used to evaluate different factors associated with increased utilization of novel sustained-release steroids.ResultsOut of a total of 4,252,532 cataract surgeries performed,..."

Medicare • Reimbursement • Surgery • US reimbursement • Cataract • Ophthalmology

SELVEDge: Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: University of Miami

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery (2) (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: EyePoint Pharmaceuticals, Inc.

New P3 trial • Cataract • Ophthalmology • Pain

A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: EyePoint Pharmaceuticals, Inc.

New P3 trial • Cataract • Ophthalmology • Pain

Real-World Experience with Intracapsular Administration of Dexamethasone Intraocular Suspension 9% for Control of Postoperative Inflammation. (PubMed, Clin Ophthalmol) - "DEXYCU (dexamethasone intraocular suspension) 9% is the first and only intraocular corticosteroid FDA-approved for postoperative inflammation, whose sustained-release formulation provides a high initial release of drug, followed by a gradual tapering...This technique also minimizes contact with metabolically active tissues such as the corneal endothelium, iris, and ciliary body. In this paper, we review the available literature on dexamethasone intraocular suspension and summarize surgeons' consensus on best practices for intracapsular administration."

Journal • Real-world evidence • Review • Cataract • Immunology • Inflammation • Ocular Inflammation • Ophthalmology

Anterior Chamber Versus Intravitreal Administration of Dexamethasone 9% Suspension in Cataract Patients with and without Glaucoma (ASCRS-ASOA 2022) - "MethodsRetrospective data were collected from patients who received dexamethasone 9% suspension (DEXYCU®; EyePoint Pharmaceuticals) either via anterior chamber administration (on-label) or intravitreal injection (off-label) after cataract surgery, with/without minimally invasive glaucoma surgery (MIGS)...All patients were given intracameral moxifloxacin at the time of surgery...1 patient in the IVD required rescue medications compared to 8 patients in the ACD group (p<0.01). Conclusion Administration of IVD or ACD does not impede the intraocular pressure reduction produced by cataract surgery combined with MIGS."

Clinical • Cataract • Glaucoma • Ophthalmology

". @LisaNijmMDJD shares her pearls for successful capsular bag administration of dexamethasone #intraocular suspension 9% https://t.co/y4DiF8qBLD #Ophthalmology #Dexycu @EyePointPharma #Surgery" (@OphthTimes)

Ophthalmology

A Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract (clinicaltrials.gov) - P4; N=60; Recruiting; Sponsor: EyePoint Pharmaceuticals, Inc.

Clinical • New P4 trial • Cataract • Immunology • Inflammation • Ocular Inflammation • Ophthalmology

Iris Atrophy After Administration of Intracameral Dexycu in Routine Cataract Surgery: A Case Series. (PubMed, Eye Contact Lens) - "None of the five eyes treated with traditional anti-inflammatory drops developed iris atrophy. The Dexycu intraocular dexamethasone implant was designed to mitigate postoperative inflammation and reduce need for topical therapy but may be associated with other potential adverse effects that warrant consideration."

Clinical • Journal • Cataract • Immunology • Inflammation • Ophthalmology

". @LisaNijmMDJD shares her pearls for successful capsular bag administration of dexamethasone intraocular suspension 9% https://t.co/s7nEHVogrK #Ophthalmology #Dexycu @EyePointPharma #Surgery" (@OphthTimes)

Ophthalmology

". @LisaNijmMDJD shares her pearls for successful capsular bag administration of dexamethasone intraocular suspension 9% https://t.co/kEgQR9KQOU #Ophthalmology #Dexycu @EyePointPharma #Surgery" (@OphthTimes)

Ophthalmology

Utilization and Cost-Analysis of Novel Dropless Steroid Alternatives for Cataract Surgery Among Medicare Beneficiaries (AAO 2021) - "Utilization and cost of dexamethasone intraocular suspension (Dexycu) and ophthalmic insert (Dextenza) were evaluated using HCPCS codes J1095 and J1096, respectively. Conclusion Dropless dexamethasone delivery technologies address patient inconvenience and poor compliance but entail disproportionately high costs compared to traditional steroid drops. This may explain the low adoption rates of these new drug delivery technologies, despite their pass-through status."

HEOR • Medicare • Reimbursement • Cataract • Ophthalmology