TORONTO, ON / ACCESSWIRE / April 20, 2021 / Ripple Therapeutics Corporation ("Ripple"), a clinical stage, ophthalmology-focused developer of novel pharmaceuticals, announced today that the first patient has been treated in RIPPLE-1, a Phase II trial evaluating IBE-814 IVT, a proprietary intravitreal dexamethasone implant targeting inflammatory retinal diseases.
"Our research suggests that ophthalmologists would welcome a safer steroid implant with an extended clinical benefit, as a treatment option for DME and RVO, and we believe that IBE-814 IVT has the potential to fulfill that need," commented Tom Reeves, President & CEO of Ripple Therapeutics. "The first treated patient marks a significant step forward in our goal of providing safe and effective treatment options for patients with sight-threatening conditions."
RIPPLE-1 is a phase II, multi-center, single-masked dose-ranging study designed to evaluate the safety and efficacy of two dosage regimens of IBE-814 IVT in patients with diabetic macular edema (DME) or macular edema due to retinal vein occlusion (RVO).
The study will enroll up to 50 eyes of 50 patients with DME or RVO at 15 ophthalmology centers in Australia and New Zealand that specialize in the diagnosis and treatment of retinal diseases. The key study endpoints are safety, macular edema and visual acuity. Retreatment will be allowed upon the return of recurrent symptoms. All patients will be followed for a planned evaluation period of 18 months.
"We are pleased to enroll and treat the very first patient in the RIPPLE-1 trial," stated Dr. Sanj Wickremasinghe, Principal Investigator at the Centre for Eye Research of Australia. "With the lower but sustained release dose of dexamethasone, I am hopeful that IBE-814 IVT will ultimately provide a much-needed treatment option."
To learn more about the RIPPLE-1 clinical trial, visit: https://clinicaltrials.gov/ct2/show/NCT04576689
About IBE-814 IVT
IBE 814 IVT, is a novel intravitreal implant designed to deliver a low, sustained dose of dexamethasone to the retina for approximately six months, without the use of polymeric carriers or excipients. The implant contains a substantially lower total dose than is used in currently marketed dexamethasone-releasing intravitreal therapies, and is intended to reduce the occurrence of dose-related adverse events that are often associated with conventional intravitreal corticosteroids. The absence of polymers in the formulation results in a much smaller implant, enabling delivery through a smaller and less traumatic 30-gauge needle.
About Diabetic Macular Edema
Persistently high blood sugar levels can damage blood vessels of the retina, leading to fluid leakage within the macula1 - the area of the retina that is associated with clear, central vision. The accumulation of fluid results in swelling of the macula (known as macular edema) which can lead to loss of visual acuity.2 DME is a leading cause of blindness in people with diabetes and affects an estimated 21 million people worldwide.3,4
About Macular Edema due to Retinal Vein Occlusion
Globally, an estimated 28 million people live with a retinal vein occlusion.5 RVO occurs when a small blood clot blocks a retinal vein preventing blood return from the retina. Bleeding and leakage of fluid from the blocked vessels into the macula cause swelling (macular edema) resulting in blurring or loss of vision. RVO is the second most common cause of vision loss due retinal vascular disease.6
About Ripple Therapeutics
Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple's Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with zero-order release kinetics without the use of polymers or excipients. Ripple has a full product pipeline in development. www.rippletherapeutics.com
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- National Eye Institute. Diabetic Retinopathy. Available at: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/diabetic-retinopathy. Accessed April 2021
- National Eye Institute. Macular Edema. Available at: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-edema#section-id-1556. Accessed April 2021.
- Leasher JL, et al. Global Estimates on the Number of People Blind or Visually Impaired by Diabetic Retinopathy: A Meta-Analysis from 1990 to 2010. Diabetes Care. 2016;39:1643-9.
- Romero-Aroca P. Managing diabetic macular edema: The leading cause of diabetes blindness. World J Diabetes. 2011;2(6):98-104. doi:10.4239/wjd.v2.i6.98.
- Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019;9:010427.
- Laouri M, Chen E, Looman M, Gallagher M. The burden of disease of retinal vein occlusion: review of the literature. Eye. 2011;25:981-8.
SOURCE: Ripple Therapeutics