Novartis has 2-year data on superiority of macular degeneration med

* Year two results consistent with previously announced key secondary endpoint
data on retinal fluid (IRF and/or SRF) showing superior reductions versus
aflibercept

* Superior reductions in central subfield thickness demonstrated at year one
were reaffirmed at year two with brolucizumab 6 mg versus aflibercept

* Robust visual gains shown in year one with brolucizumab were maintained in
year two

Novartis announced additional brolucizumab Phase III
results from year two that reaffirmed its positive year one findings.
Brolucizumab met its primary endpoint of non-inferiority versus aflibercept in
best corrected visual acuity (BCVA) and exhibited superiority in key retinal
outcomes at year one (48 weeks)[1],[2]. Secondary endpoints at year two (96
weeks) reaffirmed superiority of brolucizumab 6 mg in reduction of retinal
fluid, an important marker of disease activity in patients with neovascular age-
related macular degeneration (nAMD)[1],[3]. Approximately 20 to 25 million
people are affected by nAMD, also known as wet AMD, a leading cause of blindness
worldwide[4],[5].

The year two HAWK and HARRIER findings demonstrated that fewer patients with
nAMD had intra-retinal fluid (IRF) and/or sub-retinal fluid (SRF) – key markers
used by physicians to determine injection frequency in clinical practice – with
brolucizumab 6 mg versus aflibercept at week 96 [24% for brolucizumab 6 mg vs.
37% for aflibercept in HAWK (P=0.0001); 24% vs. 39%, respectively, in HARRIER
(P<0.0001)][1](*).

Additionally, brolucizumab 6 mg patients continued to demonstrate reductions in
central subfield thickness (CST) at week 96[1]. An increase in CST in nAMD is an
important measure of abnormal fluid accumulation and edema and may result in
reduced vision. Absolute reductions in CST from baseline were -175 µm for
brolucizumab 6 mg versus -149 µm for aflibercept in HAWK (P=0.0057) and -198 µm
versus -155 µm, respectively, in HARRIER (P<0.0001)[1](*).

Also at week 96, fewer brolucizumab 6 mg patients had sub-retinal pigment
epithelium (sub-RPE) fluid (11% for brolucizumab 6 mg vs. 15% for aflibercept in
HAWK; 17% vs. 22%, respectively, in HARRIER)[1]. Additionally, of the patients
on brolucizumab 6 mg who successfully completed year one on a 12-week dosing
interval, 82% in HAWK and 75% in HARRIER were maintained on a 12-week dosing
interval in year two[1].

“These findings at year two reaffirm the excellent year one brolucizumab data
regarding retinal fluid reduction, a key goal for physicians treating patients
with nAMD,” said Dr. Pravin U. Dugel, Managing Partner, Retinal Consultants of
Arizona; Clinical Professor, Roski Eye Institute, Keck School of Medicine,
University of Southern California; and principal investigator of both trials.
“These consistent results continue to support brolucizumab as a potential new
treatment for patients with nAMD.”

As previously announced, HAWK and HARRIER met their primary endpoint of non-
inferiority in mean change in BCVA at week 48 with brolucizumab versus
aflibercept[2]. Brolucizumab maintained robust visual gains in year two, with
mean change in BCVA of 5.9 letters for brolucizumab 6 mg versus 5.3 letters for
aflibercept in HAWK, and 6.1 letters versus 6.6 letters, respectively, in
HARRIER[1].

https://www.marketscreener.com/NOVARTIS-9364983/news/Novartis-Two-year-data-for-Novartis-brolucizumab-reaffirm-superiority-versus-aflibercept-in-reduci-27500203/