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2024-07-19| R&D

Roche Reports Positive Clinical Trial Results for Two Diabetes-Related Eye Disease Therapies

by Bernice Lottering
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On July 17 and 18, 2024, Roche announced positive clinical trial results for two of its candidate therapies targeting diabetic eye diseases. Both therapies have shown significant improvements in efficacy and safety, providing better protection for the large number of people affected by diabetes-related eye diseases. With diabetic retinopathy expected to impact 160.5 million people worldwide by 2045, these advancements offer crucial support for those at risk.

Comprehensive Approach Needed for Effective Diabetic Macular Edema Treatment

Diabetic Macular Edema (DME) is a severe complication of diabetic retinopathy. It primarily results from the over-expression of vascular endothelial growth factor (VEGF) and the disruption of the blood-retinal barrier, leading to retinal vessel leakage and macular edema. Diagnosis typically relies on optical coherence tomography (OCT) to reveal changes in retinal structure and the extent of macular edema.

Risk factors for DME include the duration of diabetes, poor glycemic control, hypertension, kidney disease, and hyperlipidemia. Traditional treatments involve laser photocoagulation to target localized leakage and diffuse edema, as well as anti-VEGF agents and corticosteroid intravitreal injections, which have shown significant clinical efficacy. However, some patients do not respond well to anti-VEGF therapy, necessitating new treatment strategies.

Emerging treatment strategies include gene therapy, immunosuppressants, non-steroidal anti-inflammatory drugs (NSAIDs), and antioxidants. These approaches aim to improve treatment outcomes, particularly for patients who do not respond to anti-VEGF treatments. Additionally, systemic factors such as hypertension, kidney disease, anemia, and sleep apnea also significantly impact the development of DME, making comprehensive management crucial for reducing macular edema and protecting vision.

Targeting Inflammation for Enhanced Diabetic Retinopathy Management

Diabetic Retinopathy (DR) is a common complication of diabetes and a leading cause of preventable blindness among working-age populations. The onset of DR is closely linked to the duration of diabetes, poor blood sugar control, and hypertension. Its pathophysiology involves genetic and epigenetic factors, increased free radicals, inflammatory factors, and elevated levels of VEGF.

Generally, DR results from microvascular complications induced by diabetes, affecting retinal microvascular leakage and obstruction. Major risk factors include the duration of diabetes, poor glycemic control, and hypertension. Traditional treatments like retinal photocoagulation and vitrectomy effectively prevent severe vision loss but cannot reverse vision impairment. Anti-VEGF therapies and corticosteroid intravitreal injections show clinical benefits, though most patients experience no significant vision improvement.

Emerging treatment strategies such as gene therapy, immunosuppressants, NSAIDs, and antioxidants are under development to enhance DR treatment outcomes. Since inflammation plays a crucial role in DR pathogenesis, targeting inflammation might offer potential therapeutic value in DR management.

Vabysmo’s Long-Term Study in Diabetic Macular Edema: Nearly 80% of Patients Extend Treatment Intervals to Quarterly

Vabysmo (faricimab), a bispecific antibody targeting both Ang-2 and VEGF-A pathways, has shown promising results in long-term treatment for diabetic macular edema (DME). Roche announced on the 17th that the 4-year data from the RHONE-X extension study reveals Vabysmo’s strong tolerability and sustained efficacy in DME patients. By the end of the study, nearly 80% of patients successfully extended their treatment intervals to every 3 or 4 months. Additionally, nearly 90% of patients showed no signs of DME after 4 years, demonstrating the drug’s significant long-term efficacy.

The RHONE-X study stands as the largest long-term extension study in the DME field to date, highlighting Vabysmo’s consistent efficacy and safety over time. This breakthrough therapy offers new hope for DME patients, especially as the global prevalence of diabetes continues to rise. Consequently, Vabysmo has the potential to become a new standard of care. Currently, Vabysmo is approved in nearly 100 countries worldwide for treating “neovascular” or “wet” age-related macular degeneration (nAMD) and DME.

Susvimo Demonstrates Continued Efficacy with Biannual Dosing

On the 18th, Roche also announced that its new ocular implant, Susvimo, maintains sustained efficacy and stable safety for treating DME and diabetic retinopathy (DR). This news garnered widespread attention when presented at the American Society of Retina Specialists (ASRS) 2024 Annual Meeting.

According to two-year data from the Pagoda and PAVILION Phase III clinical trials, Susvimo, an implantable device using the Port Delivery System to release a customized formulation of ranibizumab, has shown remarkable results. In the Pagoda study, diabetic macular edema patients receiving Susvimo treatment saw significant vision improvement with biannual dosing, and 95% of patients required no additional injections during the study. In the PAVILION study, diabetic retinopathy patients benefited from a 9-month dosing schedule, with significant improvements in Diabetic Retinopathy Severity Scale (DRSS) scores from baseline, also without needing extra injections.

As the world’s first refillable ocular implant, Susvimo offers a unique therapy with continuous drug release. This design aims to control retinal vascular leakage, reduce central subfield thickness (CST), and decrease intraocular fluid accumulation, ultimately helping to prevent vision loss.

References: 

  1. https://www.roche.com/media/releases/med-cor-2024-07-17b
  2. https://www.roche.com/media/releases/med-cor-2024-07-18
  3. https://link.springer.com/article/10.2165/11538340-000000000-00000
  4. https://www.mdpi.com/2073-4409/11/12/1950
  5. https://link.springer.com/article/10.1007/s11892-019-1188-4
  6. https://www.diabetesresearchclinicalpractice.com/article/S0168-8227(13)00012-0/abstract
  7. https://www.aaojournal.org/article/S0161-6420(15)00305-X/abstract
  8. https://www.tandfonline.com/doi/full/10.1080/14712598.2018.1545836
  9. https://www.sciencedirect.com/science/article/abs/pii/S135094621500066X?via%3Dihub
  10. https://www.nature.com/articles/nrdp201612
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