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

Demonstrating the Range of Achievable Release Kinetics with a Dexamethasone Prodrug-Based Intravitreal Implant (ARVO 2026) - "Conclusions The results of this work demonstrate the ability to modulate sustained release drug kinetics utilizing the unique material properties of our proprietary prodrugs formulated with free drug to expand the range of achievable drug dosing without the use of polymers. This work highlights the versatility of our novel prodrug-based platform and the different approaches that can be used to tune release rates for ocular applications."

Ophthalmology

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