dexamethasone (IBE-814) / Ripple Therap - LARVOL DELTA

Safety and Efficacy of IBE-814 Intravitreal (IVT) Implant - A Sustained, Low Dose Dexamethasone Therapy (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Ripple Therapeutics Pty Ltd | Active, not recruiting ➔ Completed | Trial completion date: Aug 2024 ➔ Mar 2024

Trial completion • Trial completion date • Diabetic Macular Edema • Macular Edema • Ophthalmology • Retinal Vein Occlusion

Efficacy and safety of a low dose dexamethasone implant for diabetic macular edema and retinal vein occlusion: Results of the First-In-Human Phase 2 RIPPLE-1 trial (ARVO 2024) - "The IBE-814 IVT Implant demonstrated sustained reductions in CST, with improved or stable BCVA, for at least 6 months in DME and RVO and has been well-tolerated to date. The results of the study will be presented along with efficacy and safety trends that will inform dose selection for future trials. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • P1 data • P2 data • Cataract • Diabetic Macular Edema • Ophthalmology • Retinal Vein Occlusion

IBE-814 IVT Implants reduce treatment burden in subjects with DME and RVO due to sustained-release of dexamethasone: An analysis of the First-in-Human Phase 2 RIPPLE-1 trial (ARVO 2024) - "The IBE-814 IVT Implant provided a sustained treatment effect of at least 6 months in the majority of RIPPLE-1 study subjects. Among previously treated subjects, the implant reduced the burden of treatment by at least 50% in the Low Dose cohorts and at least 80% in the High Dose cohorts. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • P1 data • P2 data • Diabetic Macular Edema • Ophthalmology • Retinal Vein Occlusion

Safety and Efficacy of IBE-814 Intravitreal (IVT) Implant - A Sustained, Low Dose Dexamethasone Therapy (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Ripple Therapeutics Pty Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2023 ➔ Aug 2024 | Trial primary completion date: Apr 2022 ➔ Apr 2024

Enrollment closed • Trial completion date • Trial primary completion date • Diabetic Macular Edema • Macular Edema • Ophthalmology • Retinal Vein Occlusion

Controlled release of low-molecular weight, polymer-free corticosteroid coatings suppresses fibrotic encapsulation of implanted medical devices. (PubMed, Biomaterials) - "Anti-inflammatory drugs, such as dexamethasone, can suppress the foreign body reaction for a few days post-surgery, but lasting drug delivery strategies for long-term implanted materials remain an unmet need...Consequently, fibroblast activation, collagen deposition and fibrotic encapsulation are suppressed at least 45 days post-implantation. Thus, our approach to protect implants from host rejection is advantageous over polymeric drug delivery systems, which typically have low drug loading capacity (<30%), initial burst release profiles, and unpredictable release kinetics."

Journal • Fibrosis • Immunology • Inflammation

Polymer-free corticosteroid dimer implants for controlled and sustained drug delivery. (PubMed, Nat Commun) - "As an example, when used as ocular implants in rats, a dexamethasone dimer implant is shown to effectively inhibit inflammation induced by lipopolysaccharide. In a rabbit model, dexamethasone dimer intravitreal implants demonstrate predictable pharmacokinetics and significantly extend drug release duration and efficacy (>6 months) compared to a leading commercial polymeric dexamethasone-releasing implant."

Journal • Immunology • Inflammation

Safety and Efficacy of IBE-814 Intravitreal (IVT) Implant - A Sustained, Low Dose Dexamethasone Therapy (clinicaltrials.gov) - P2; N=50; Recruiting; Sponsor: Ripple Therapeutics Pty Ltd; Not yet recruiting ➔ Recruiting; Trial completion date: Feb 2023 ➔ Jun 2023

Clinical • Enrollment open • Trial completion date • Diabetic Macular Edema • Macular Edema • Ophthalmology • Retinal Vein Occlusion