Novartis eye treatment for diabetics shows positive results in Phase III trial

pharmafile | May 4, 2021 | News story | Manufacturing and Production DME, Novartis, diabetic macular edema, macular edema, pharma, pharma news 

Novartis’ Beovu treatment for diabetic macular edema (DME) – an eye condition that can cause blindness – has shown positive results one year into Phase III trials evaluating the drug.

DME is the leading cause of blindness in adults in developed countries, affecting 12% of people with Type 1 diabetes and 28% of those with Type 2 diabetes. Consistently high blood sugar levels associated with diabetes can damage small blood vessels in the eye, causing them to leak fluid.

In two separate Phase III studies – KESTREL and KITE – Beovu was tested versus aflibercept, a drug already used to treat wet macular degeneration, in 926 patients.

Both trials showed Beovu to be as effective as aflibercept in change in best corrected visual acuity (BCVA), with patients on aflibercept performing mildly better in the first trial (10.5 letters versus 9.2), and participants on Beovu performing slightly better in the second (10.6 letters versus 9.4).

However, patients on Beovu experienced a better fluid resolution between weeks 32 and 52 – a sign that the disease was improving. 

The new Novartis drug may also need to be dosed every six weeks after the initial phase, which would mean fewer injections for patients from the start of treatment.

Beovu is already approved for the treatment of wet age-related macular degeneration in more than 60 countries, including the US, UK and EU. 

Dr David M Brown, Director of Clinical Research at the Retina Consultants of Texas, and Principal Investigator of the KESTREL clinical trial, said: “Treatment for diabetic macular edema is a high unmet medical need in the US and globally. Our goal as physicians is to work on preventing blindness for the significant proportion of diabetics affected by this condition. 

“DME patients often struggle with adherence due to the need to manage multiple comorbidities related to diabetes. The KESTREL and KITE clinical trials – the first pivotal trials to examine a longer dosing interval in the loading phase – confirm Beovu’s potential to be an important therapy for these patients.”

Jill Hopkins, Global Development Unit Head of Ophthalmology at Novartis, added: “We are pleased to share these data, which underscore Beovu’s potential to address an unmet need in the DME landscape. 

“With these data demonstrating vision gains, fluid resolution, and the potential for less frequent injections for eligible patients, we are one step closer to providing DME patients with a potential new treatment option.”

Jack Goddard

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