- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Trial completion date, Trial primary completion date, Surgery: A Study to Evaluate the Efficacy and Safety of DEXYCU (clinicaltrials.gov) - Apr 4, 2024
P3, N=0, Withdrawn,
Trial completion date: Apr 2024 --> Sep 2023 | Trial primary completion date: Apr 2024 --> Sep 2023
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Enrollment change, Trial withdrawal, Surgery: A Study to Evaluate the Efficacy and Safety of DEXYCU (clinicaltrials.gov) - Sep 8, 2023
P3, N=0, Withdrawn,
Trial completion date: Apr 2024 --> Sep 2023 | Trial primary completion date: Apr 2024 --> Sep 2023 N=150 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| Dextenza (dexamethasone punctal plug) / Ocular Therap, Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap, Omidria (phenylephrine/ketorolac) / Omeros
Trial completion, Enrollment change, Surgery: Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery (clinicaltrials.gov) - Jun 15, 2023
P4, N=15, Completed,
N=150 --> 0 | Not yet recruiting --> Withdrawn Unknown status --> Completed | N=75 --> 15
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Xpovio (selinexor) / Karyopharm, Menarini, FORUS Therap
Enrollment open: SELVEDge: Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - Mar 30, 2023
P2, N=33, Recruiting,
Unknown status --> Completed | N=75 --> 15 Not yet recruiting --> Recruiting
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Xpovio (selinexor) / Karyopharm, Menarini, FORUS Therap
New P2 trial: SELVEDge: Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - Sep 7, 2022
P2, N=33, Not yet recruiting,
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Review, Journal, Real-world evidence: Real-World Experience with Intracapsular Administration of Dexamethasone Intraocular Suspension 9% for Control of Postoperative Inflammation. (Pubmed Central) - Jun 28, 2022
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.
- |||||||||| dexamethasone / Generic mfg.
Anterior Chamber Versus Intravitreal Administration of Dexamethasone 9% Suspension in Cataract Patients with and without Glaucoma (WEWCC - Level 1, 143C) - Apr 26, 2022 - Abstract #ASCRSASOA2022ASCRS-ASOA_1480;
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.
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Clinical, Journal: Iris Atrophy After Administration of Intracameral Dexycu in Routine Cataract Surgery: A Case Series. (Pubmed Central) - Mar 19, 2022
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.
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
V06 - The Capsular Bag: A New Site for Drug Delivery (Morial Convention Center) - Oct 20, 2021 - Abstract #AAO2021AAO_2103;
This study evaluating the injection of Dexycu into a new location, the capsular bag, proved very promising. It was conducted independently and without support of the manufacturer.
- |||||||||| Dextenza (dexamethasone punctal plug) / Ocular Therap, Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Utilization and Cost-Analysis of Novel Dropless Steroid Alternatives for Cataract Surgery Among Medicare Beneficiaries (Morial Convention Center) - Oct 20, 2021 - Abstract #AAO2021AAO_1659;
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.
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Capsular Bag: A New Site for Drug Delivery () - Jul 19, 2021 - Abstract #ASCRSASOA2021ASCRS_ASOA_74;
While VR surgeons have enjoyed innovation in drug delivery, cataract surgeons have had to accept topical therapy for decades despite disadvantages. This independent study evaluated the injection of Dexycu into a new location, the capsular bag.
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
[VIRTUAL] Effect of Dexamethasone Intracameral Drug-Delivery Suspension on Macular Thickness after Vitreoretinal Surgery () - May 13, 2021 - Abstract #ARVO2021ARVO_2704;
Intracameral dexamethasone drug-delivery suspension placed in the anterior chamber after vitreoretinal surgery was associated with a significant reduction in macular thickness up to 12 weeks following vitreoretinal surgery, whereas patients receiving daily topical corticosteroids demonstrated significantly more OCT MT at 4 and 8 weeks post-operatively. These results indicate a greater benefit of intracameral dexamethasone drug-delivery suspension for preventing post-operative causes of increased macular thickness including cystoid macular edema compared to topical anti-inflammatory treatment among patients undergoing vitreoretinal surgery.
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Trial completion: Effect of Intraoperative Dexamethasone on Post-op Dry Eye (clinicaltrials.gov) - Jan 29, 2021
P4, N=40, Completed,
These results indicate a greater benefit of intracameral dexamethasone drug-delivery suspension for preventing post-operative causes of increased macular thickness including cystoid macular edema compared to topical anti-inflammatory treatment among patients undergoing vitreoretinal surgery. Active, not recruiting --> Completed
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Trial completion, Phase classification, Surgery: A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1% (clinicaltrials.gov) - Dec 11, 2020
P4, N=31, Completed,
Active, not recruiting --> Completed Recruiting --> Completed | Phase classification: P2 --> P4
- |||||||||| Decadron (dexamethasone) / Merck (MSD), Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
[VIRTUAL] Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye (VM) - May 23, 2020 - Abstract #ASCRSASOA2020ASCRS-ASOA_2139;
Purpose To evaluate the impact of intraoperative Dexycu (9% dexamethasone) administered intraoperatively during cataract surgery on the postoperative signs and symptoms of dry eye...The standard postoperative cataract regimen included topical gatifloxacin and topical prednisolone acetate...Standard regimen of topical steroid and antibiotic does not improve postoperative dry eye signs. Additional studies should be done to assess if Dexycu without the use of concurrent topical steroid impacts dry eye signs and symptoms.
- |||||||||| dexamethasone / Generic mfg., Decadron (dexamethasone) / Merck (MSD)
Journal: Dexamethasone intracameral drug-delivery suspension for inflammation associated with vitreoretinal surgery. (Pubmed Central) - May 20, 2020
No serious ocular adverse events were noted up to POD 90 in either group. The ICD drug-delivery suspension placed in the anterior chamber after vitreoretinal surgery was more effective than topical corticosteroids in treating inflammation occurring 1 week following vitreoretinal surgery and thus may be an alternative to daily corticosteroid drop installation in this patient population.
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Trial completion: DEXYCURetro: DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001 (clinicaltrials.gov) - May 4, 2020
P=N/A, N=527, Completed,
The ICD drug-delivery suspension placed in the anterior chamber after vitreoretinal surgery was more effective than topical corticosteroids in treating inflammation occurring 1 week following vitreoretinal surgery and thus may be an alternative to daily corticosteroid drop installation in this patient population. Active, not recruiting --> Completed
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Trial completion date, Trial primary completion date, Surgery: A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1% (clinicaltrials.gov) - Apr 19, 2020
P2, N=30, Recruiting,
Active, not recruiting --> Completed Trial completion date: Jun 2020 --> Dec 2020 | Trial primary completion date: Mar 2020 --> Nov 2020
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Dexamethasone Intracameral Drug-Delivery Suspension for Inflammation Associated with Vitreoretinal Surgery (Exhibit Hall: Posterboard# A0406) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5132;
Purpose To evaluate the efficacy of an anterior chamber intracameral dexamethasone drug-delivery suspension (Dexycu; EyePoint Pharmaceuticals, Watertown, MA) that provides medication for up to 21 days with a single application in treating postoperative inflammation in patients undergoing vitreoretinal surgery compared to daily post-operative treatment with topical corticosteroids for up to 1 month.Methods Retrospective case-matched comparison of patients undergoing initial vitreoretinal surgery by a single surgeon...Does a small injection after vitreoretinal surgery result in a similar post-operative anti-inflammatory effect as topical corticosteroids in patients undergoing vitreoretinal surgery? This intra-operative option may reduce the need for patients otherwise required to use post operative eye drops for a month after vitreoretinal surgery.
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Outcomes of dexamethasone intraocular suspension during cataract surgery and concomitant cataract-micro-invasive glaucoma surgery (MIGS) (Exhibit Hall: Posterboard# B0340) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4935;
Purpose Dexamethasone intraocular suspension 9% (DEXYCU®) offers a sustained-release, FDA-approved alternative to anti-inflammatory drops...Given that atrophy was location-specific, occurring with 45% of AC aliquots, it may be mitigated by confining the aliquot to the ciliary sulcus. Further research should be pursued to determine how surgical technique, eye features, and drug properties affect sulcus escape.
|
