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December 10, 2021updated 11 Jul 2022 2:15pm

Novartis reports positive data from diabetic macular oedema trial of Beovu

Lesser number of subjects in the Beovu arm experienced intraocular fluid and/or sub-retinal fluid at year two.

Novartis has reported positive year two (week 100) data from the Phase III KESTREL clinical trial of Beovu (brolucizumab) to treat individuals with visual impairment that occurs due to diabetic macular oedema (DME).

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Beovu is currently approved to treat wet age-related macular degeneration (AMD) in more than 70 nations worldwide.

The international, double-masked, randomised trial analysed the safety and efficacy of the therapy and aflibercept to treat visual impairment.

Two-year data established the visual acuity gains, fluid reduction results and safety profile from the first year.

Trial findings from week 100 were in line with those reported at first year, including a continued decline in central subfield thickness (CSFT) and maintenance of best-corrected visual acuity (BCVA).

More than 40% of the subjects in the Beovu arm sustained on 12-week dosing intervals and 70% of those who concluded the initial cycle of 12 weeks after loading continued on dosing for the same period through year two.

This data indicated the potential ability of Beovu to provide fluid resolution in more individuals with DME with less number of injections as against aflibercept.

Furthermore, less number of Beovu treated subjects experienced intraocular fluid and/or sub-retinal fluid (IRF/SRF) as against those in the aflibercept arm.

For a 6mg dose of Beovu, intraocular inflammation (IOI) rates were reported to be 4.2% versus 1.1% for aflibercept while most of the IOI episodes were easily managed and resolved with no clinical consequences.

A common microvascular complication in diabetic individuals, DME could have a debilitating effect on visual acuity and can cause blindness.

This August, the company reported positive results from two Phase III trials, KITE and KINGFISHER, of Beovu to treat DME.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
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