Novartis announces positive results from year two of the Phase III trial of Beovu in diabetic macular edema

Novartis today announced the first interpretable results from year two (week 100) of the Phase III KESTREL study.

According to the company, KESTREL assessed the safety and efficacy of brolucizumab 6 mg (Beovu) in patients with visual impairment due to diabetic macular edema (DME).

Results from year two confirmed the visual acuity gains, fluid reduction findings and safety profile from year one, while addressing the burden of frequent treatments for DME patients^1,2.

Results from year two of KESTREL were consistent with those seen at year one, including maintenance of best-corrected visual acuity (BCVA) and sustained reductions in central subfield thickness (CSFT)^1,2.

Additionally, numerically fewer brolucizumab patients had intraocular fluid and/or sub-retinal fluid (IRF/SRF) versus patients treated with aflibercept¹. CSFT is a key indicator of fluid in the retina, and fluid is a key marker of disease activity^3,4.

More than 40% of brolucizumab patients were maintained on 12-week dosing intervals, and 70% of patients who completed the first 12-week cycle after loading remained on 12-week dosing through year two, showing the potential for brolucizumab to offer fluid resolution in more DME patients with fewer injections versus aflibercept¹.

“With an average age at diagnosis of 48 years, DME primarily affects working-age adults, which means managing their vision, in addition to multiple comorbidities related to diabetes, may result in loss of work productivity and employment instability^5,6,” said David M Brown MD, director of research at Retina Consultants of Texas. “The extended dosing and fluid resolution observed in year two of the KESTREL clinical trial suggest Beovu has the potential to help appropriate patients more conveniently and effectively manage their disease with dosing intervals every 12 weeks after an initial loading phase.”

Further details of year-two findings from the KESTREL trial, along with findings from KITE*, another pivotal Phase III trial of brolucizumab in DME, will be presented at upcoming medical congresses.

References

1. Data on file. KESTREL (year two) first interpretable results. Novartis, 2021.
2. Brown D, Wolf S, Garweg JG, et al. Brolucizumab for the treatment of visual impairment due to diabetic macular edema: 52-week results from the KESTREL & KITE studies. Presented at: The Association for Research in Vision and Ophthalmology 2021 Annual Meeting. May 2021.
3. Kang SW, Park CY, Ham D-I. The correlation between fluorescein angiographic and optical coherence tomographic features in clinically significant diabetic macular edema. Am J Ophthalmol. 2004;137(2):313-322.
4. Arnold J, Markey CM, Kurstjens NP, Guymer GH. The role of sub-retinal fluid in determining treatment outcomes in patients with neovascular age-related macular degeneration--a phase IV randomised clinical trial with ranibizumab: the FLUID study. BMC Ophthalmol. 2016;143(4):679-680.
5. Petrella RJ, Blouin J, Davies B, Barbeau M. Prevalence, Demographics, and Treatment Characteristics of Visual Impairment due to Diabetic Macular Edema in a Representative Canadian Cohort. J Ophthalmol. 2012;2012:159167.
6. Kiss S, Chandwani HS, Cole AL, Patel VD, Lunacsek OE, Dugel PU. Comorbidity and health care visit burden in working-age commercially insured patients with diabetic macular edema. Clin Ophthalmol. 2016;10:2443-2453.