Press Release: Novartis Phase III Beovu(R) data show potential for fluid resolution in more diabetic macular edema patients with fewer injections versus afli...

-- In KESTREL and KITE, Beovu (brolucizumab) 6 mg met the primary endpoints

of non-inferiority in change in best corrected visual acuity from

baseline versus aflibercept 2 mg at year one in diabetic macular edema

(DME) patients1

-- More patients treated with Beovu 6 mg experienced fluid (IRF/SRF)

resolution at week 32 and week 52 versus aflibercept; fluid is a key

marker of disease activity in DME1

-- Beovu demonstrated an overall well-tolerated safety profile in KESTREL

and KITE1

-- Phase III KESTREL and KITE trials are the first pivotal trials to assess

an anti-VEGF on six-week dosing intervals in the loading phase,

suggesting Beovu may offer fewer injections from the start of treatment1

-- Novartis is committed to bringing Beovu 6 mg to DME patients and will

submit data from KESTREL and KITE to global health authorities in H1 2021

Basel, May 1, 2021 -- Novartis today announced positive one-year results

of the Phase III KESTREL and KITE* studies, evaluating the efficacy and

safety of Beovu(R) (brolucizumab) 6 mg in diabetic macular edema (DME).

Both studies met their primary endpoints of non-inferiority in change in

best corrected visual acuity (BCVA) from baseline for Beovu 6 mg versus

aflibercept 2 mg at year one(1). In KESTREL, patients on Beovu 6 mg

gained a mean of 9.2 letters versus 10.5 letters for patients on

aflibercept 2 mg(1). In KITE, patients on Beovu 6 mg gained a mean of

10.6 letters versus 9.4 letters for patients on aflibercept 2 mg(1).

These results will be presented at the Association for Research in

Vision and Ophthalmology (ARVO) 2021 Annual Meeting.

In pre-specified secondary endpoints, fewer eyes treated with Beovu had

intraretinal and/or subretinal fluid (IRF/SRF) at week 32 (first

assessment of disease activity) and week 52 versus eyes treated with

aflibercept(1). More eyes treated with Beovu 6 mg than eyes treated

with aflibercept achieved central subfield thickness (CSFT) levels below

280 m at weeks 32 and 52(1). Fluid is a key marker of disease

activity in DME and CSFT is a key indicator of fluid in the retina(1).

"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," said David M Brown MD FACS, Director of Clinical Research at

the Retina Consultants of Texas and principal investigator of the

KESTREL clinical trial. "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."

To study its potential in reducing treatment burden, Beovu was given at

six-week dosing intervals during the loading phase versus aflibercept,

which was given at the standard four-week dosing intervals, in line with

its label(1,2). Following the loading phase, over half of patients in

the Beovu 6 mg arm (55.1% in KESTREL and 50.3% in KITE) remained on a

three-month dosing interval through year one, based on a treatment

approach determined by disease activity assessment(1). If disease

activity was detected, Beovu 6 mg patients were switched to two-month

intervals through the end of the trial(1). All aflibercept patients

were on a two-month interval after the loading phase(1).

"We are pleased to share these data, which underscore Beovu's potential

to address an unmet need in the DME landscape," said Jill Hopkins,

Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals.

"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."

The Phase III KESTREL and KITE studies enrolled a total of 926 patients

in 36 countries. Beovu 6 mg is the commercialized dose in wet

age-related macular degeneration (AMD)(3). The brolucizumab 3 mg arm,

which was only included in KESTREL, did not meet the primary endpoint(1)

.

Beovu was overall well-tolerated in KESTREL and KITE(1). The most

common ocular and non-ocular adverse events (>=5%) in KESTREL and KITE

were conjunctival hemorrhage, nasopharyngitis and hypertension(4). IOI

rates in KESTREL were 4.7% for brolucizumab 3 mg (including 1.6% retinal

vasculitis), 3.7% for Beovu 6 mg (including 0.5% retinal vasculitis),

and 0.5% for aflibercept 2 mg(1). IOI rates in KITE were equivalent

(1.7%) between the Beovu 6 mg and aflibercept 2 mg arms with no retinal

vasculitis reported(1). Retinal vascular occlusion was reported in

KESTREL for brolucizumab 3 mg (1.1%) and 6 mg (0.5%), and in KITE for

brolucizumab and aflibercept (0.6% each)(1). The majority of these

events were manageable and resolved with or without treatment(1).

Novartis is committed to bringing Beovu 6 mg to market for DME patients,

subject to regulatory approvals, and will be submitting these one-year

data from the KESTREL and KITE trials to global health authorities in H1

2021. Novartis anticipates two-year results from KESTREL and KITE later

in 2021.

About Diabetic Macular Edema

Diabetic macular edema (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(5). Consistently high blood sugar

levels associated with diabetes can damage small blood vessels in the

eye, causing them to leak fluid(6). This damage leads to an excess of

vascular endothelial growth factor (VEGF)(5) (,6). VEGF is a protein

that stimulates the growth of blood vessels(5) (,6). At elevated levels

in DME, VEGF stimulates the growth of abnormal, leaky blood vessels(5) (,

6). The resulting accumulation of fluid (known as edema) in the macula

can lead to vision loss(5,6). The macula is the area of the retina

responsible for sharp, central vision(6). Early symptoms of DME include

blurry or wavy central vision and distorted color perception, although

the disease can also progress without symptoms at early stages(6) (,7).

About Beovu (brolucizumab)

Beovu (brolucizumab, also known as RTH258) is approved for the treatment

of wet age-related macular degeneration (AMD) in more than 60 countries,

including in the US, EU, UK, Japan, Canada and Australia(3,) (8) (-) (1)

(1). Additional trials, which study the effects of brolucizumab in

patients with wet AMD, DME, retinal vein occlusion (RVO) and

proliferative diabetic retinopathy (PDR), are currently ongoing.

About Novartis in Ophthalmology

At Novartis, our mission is to discover new ways to improve and extend

people's lives. In ophthalmology, we develop and deliver life-changing

medicines and therapies for diseases and conditions from front to back

of the eye, enabled by data and transformative technologies. Our

ophthalmic solutions reach more than 150M people per year, from

premature infants to the elderly.

*Kite Pharma, Inc. is neither a sponsor nor associated with Novartis'

KITE trial.

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