Breaking the barriers in the management of neovascular AMD

Breaking the barriers in the
management of Neovascular
AMD : HAWK and HARRIER

• The views, opinions, ideas etc expressed therein are solely those of the participants. Novartis does not certify the accuracy,
completeness, currency of any information and shall not be responsible or in anyway liable for any errors, omissions or inaccuracies
in such information. Novartis is not liable to you in any manner whatsoever for any decision made or action or non-action taken by
you in reliance upon the information provided. Novartis does not recommend the use of its products in unapproved indications and
recommends to refer to complete prescribing information prior to using any of the Novartis products.
• For the use of only registered medical practitioners or a hospital or a laboratory
• Issued in scientific services to Medical professionals
• For more information, please contact : Novartis Healthcare Private Limited, Inspire BKC, Part of 601 & 701, Bandra Kurla Complex,
Bandra (East), Mumbai – 400 051, Maharashtra, India, Tel: +91 22 50243000
Disclaimer
Promodeck/Retina-HO/Pagenax/65824/19 Aug 2020

Neovascular AMD in INDIA
Early AMD 16.37% 20.91%
Late AMD 2.32% 2.26%
Eye (2016) 30, 688–697

Real-world data: patients do not receive the full
loading dose, impacting on final visual outcomes
54.5
56.4
+3.8
40
45
50
55
60
65
70
Mean baseline VA 12 month Mean VA change from baseline
Patients receiving a total of 6-9 injections
LUMINOUS
Visual
acuity
(ETDRS
letters)
with loading dose without loading dose
(n=911) (n=179)
−0.4
Loading dose: 3 monthly injections administered at initiation of treatment. Data not shown for 1-2 and ≥ 10 injection strata due to low number of patients.
ETDRS, Early Treatment Diabetic Retinopathy Study; VA, visual acuity
1. Holz FG, et al. EURETINA 2017; 2. Data on file

Unmet needs from the physicians’ perspective
Physicians still identify treatment and monitoring burden as key unmet
needs in nAMD management despite flexible dosing
0 10 20 30 40 50 60 70 80 90
Improved efficacy
Reduced treatment
burden
Improved safety
Long acting/
sustained delivery
New treatment
mechanisms of action
US 37.0%
Intl 37.1%
US 56.3%
Intl 70.6%
US 73.2%
Intl 66.1%
US 6.3%
Intl 13.6%
US 31.9%
Intl 37.1%
What are the greatest unmet needs regarding nAMD treatment?a
ASRS Preferences and Trends (PAT)
membership survey 20183
aData gathered from 1029 retina specialists; 1. Holz FG, et al. Br J Ophthalmol. 2015;99:220-226; 2. Mantel I. Trans Vis Sci Tech. 2015;4:6;
3. ASRS Preferences and Trends (PAT) membership survey 2018. ASRS, American Society of Retina Specialists; Intl, international; US, United States
“Indeed,........monitoring visits are the
most time- and resource-consuming part
of patient care with anti-VEGF therapy
for individuals with nAMD”
- Mantel I. Trans Vis Sci Tech 20152

Stressed clinic capacity may impact timely
treatment
Adoption of flexible regimens, particularly T&E, to increase
individualization and reduce the burden on healthcare resources4-7
However, this may result in delays in detection of
recurrences and suboptimal
treatment frequency8,9
Why do you believe discontinuous anti-VEGF treatment for nAMD is
retina specialists’ most common regimen?a
0 10 20 30 40 50 60
US 17.1%
Intl 22.9%
US 23.1%
Intl 21.8%
US 2.7%
Intl 3.4%
US 48.3%
Intl 44.0%
US 8.8%
Intl 7.8%
A. Vision is the same with continuous
and discontinuous treatment
B. Patients prefer fewer shots, even if
they lose some vision
C. Physicians prefer fewer shots, even
if patients lose some vision
Combination of B and C
Other
In the ASRS PAT survey,
many retina specialists believed that discontinuous anti-VEGF
treatment is used as a result of physician or patient preference,
even if this results in some vision loss4
. Amoaku W, et al. Eye. 2012;26(suppl 1):S2-S21; 2. Amoaku W. https://www.rcophth.ac.uk/wp-content/uploads/2014/12/2013-SCI-302-Maximising-Capacity-in-AMD-Services-July-2013.pdf. Accessed May 4, 2017; 3. Samalia P, et al. N
Z Med J. 2016;129:32-8; 4. ASRS Preferences and Trends (PAT) membership survey 2016; 5. Boyer DS, et al. Ophthalmology. 2009;116:1731-1739; 6. Busbee BG, et al. Ophthalmology. 2013;120:1046-56; 7. Regillo CD, et al. Am J
Ophthalmol. 2008;145:239-48; 8. Wong WL, et al. Lancet Glob Health. 2014;2:e106-e116; 9. Finger RP, et al. Acta Ophthalmol. 2013;91:540-6.

An ongoing challenge is to maintain nAMD treatment
efficacy while reducing clinic visits.
. Freund KB, Mrejen S, Gallego-Pinazo R. An update on the pharmacotherapy of neovascular age-related macular degeneration. Expert Opin Pharmacother. 2013;14: 1017e1028.
. Holz FG, Schmitz-Valckenberg S, Fleckenstein M. Recent developments in the treatment of age-related macular degeneration. J Clin Invest. 2014;124:1430e1438.

What is a single-chain antibody fragment
(scFv)?
An scFv represents the smallest functional unit of an antibody that still retains full
binding capacity to its target1
Single-chain antibody fragments (scFv) are the smallest functional unit of an
antibody, allowing delivery of a greater molar dose compared with larger
molecules and the potential for more effective tissue penetration,attributes
designed to increase duration
Brolucizumab
. Ophthalmology 2016;123:1080-1089

HAWK and HARRIER
HAWK and HARRIER are 2 similarly designed phase 3 trials comparing
Brolucizumab with Aflibercept to treat nAMD.
Ophthalmology 2020;127:72-84
Dugel PU, Singh RP, Koh A, Ogura Y, Weissgerber G, Gedif K, Jaffe GJ, Tadayoni R, Schmidt-Erfurth U, Holz FG, HAWK and HARRIER: 96-Week outcomes from the phase trials of brolucizumab for neovascular age-related macular degeneration,
Ophthalmology (2020),

HAWK and HARRIER : Multiple international
study sites
Study locations: Global, including the US Study locations: Global, excluding the US
408 study
sites

• Any active intraocular or periocular infection
or active intraocular inflammation in either eye
• Fibrosis or geographic atrophy
• Any approved or investigational treatment for nAMD
in study eye at any time
• Any history or evidence of concurrent intraocular
condition in study eye that could require medical or
surgical intervention
• Uncontrolled glaucoma in study eye
• Written informed consent
• Patients aged ≥50 years
• Active CNV lesion secondary to nAMD that
affects the study eye; total area of CNV >50% of
the total lesion
• IRF and/or SRF affecting the central subfield
• BCVA between 78 and 23 ETDRS letters, inclusive
HAWK and HARRIER: Patient
selection criteria
Key Inclusion Criteria Key Exclusion Criteria

HAWK and HARRIER Study design :
Disease activity assessment criteria
Disease Activity at Week 16
1.Decrease in BCVAof ≥ 5 letters
compared with Baseline
2. Decrease in BCVAof ≥ 3 lettersand
CSFTincrease ≥ 75μm comparedwith
Week12
3.Decreasein BCVAof ≥ 5 lettersdue to
Neovascular AMD disease activity
comparedwith Week12
4.New or worse intra-retinal cysts (IRC)
/ intra-retinal fluid (IRF) compared
with Week12
Disease Activity at week 20,32,44
1.Decreasein BCVAof ≥ 5 letters due to
comparedwith Week12
Disease Activity at week 56,68,80,92
1.Decreasein BCVAof ≥ 5 letters due to
comparedwith Week48

HAWK and HARRIER : CONSORT DIAGRAM
FOR HAWK
13
All Enrolled (N= 1775)
Randomized (N=1082)
Brolucizumab 3mg
Randomized 360
Full set Analysis 358
Safety analysis Set 358
Per protocol set 325
Brolucizumab 6mg
Randomized : 361
Full Analysis Set : 360
Safety Analysis Set : 360
Per Protocol Set : 328
Aflibercept 2mg
Randomized : 361
Discontinued Study Treatment prior to week 48 : 31
Adverse Events : 8
Physicians Decision : 2
Protocol Deviation : 1
Progressive Disease : 3
Withdrawal by the patient ; 10
Death : 4
Lost to follow up : 1
Others :2
Discontinued Study Treatment prior to week 48 : 37
Adverse Events : 11
Death : 3
Discontinued Study Treatment prior to week 48 :46 Adverse
Events : 8
Death : 6
Lack of Efficacy :4
Screening Failure ( n=693)

HAWK and HARRIER : CONSORT DIAGRAM FOR
HARRIER
14
All Enrolled (N= 1048)
Randomized (N=743)
Screening Failure ( n=305)
Brolucizumab 6mg
Randomized : 372
Aflibercept 2mg
Randomized : 361
Discontinued Study Treatment prior to week 48 :
25
Adverse Events : 12
Death : 3
Lack of Efficacy : 1
Discontinued Study Treatment prior to week 48 :24 Adverse
Events : 4
Death : 4
Lack of Efficacy :1
Dugel PU, Singh RP, Koh A, Ogura Y, Weissgerber G, Gedif K, Jaffe GJ, Tadayoni R, Schmidt-Erfurth U, Holz FG, HAWK and HARRIER: 96-Week outcomes from the phase trials of brolucizumab for neovascular age-related macular degeneration, Ophthalmology (2020),

HAWK and HARRIER : Study Design
Matched Phase Maintenance Phase : Aflibercept (q8w) Brolucizumab (q8w/q12w)
0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96
Week
+/-
Brolucizumab 3mg/6mg
Aflibercept 2mg
Primary End Point Study End
Disease Assemement
Brolucizumab 3mg/6mg Aflibercept 2mg

HAWK and HARRIER Study Design :Dosing
Interval Adjustment : HAWK
16
0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96
IF DA was detected at week 16 16 24 32 40 48 56 64 72 80 88
IF DA was detected at week 20
20 28 36 44 76 84
52 60 68 92
32 40 48 56 64 72 80 88
44 52 60 68 76 84 92
56 64 72 80 88
68 76 84 92
A
80 88
IF DAwas detected at week 92
92
If disease activity was detected at any DAA visit , patients on
Brolucizumab( q12w) were adjusted to and remained on(q8w)
Week

HAWK and HARRIER Study Design : Dosing
Interval Adjustment : HARRIER
17
0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96
16 24 32 40 48 56 64 72 80 88
20 28 36 44 52 60 68 76 84 92
28 36 44 52 60 68 76 84 92
32 40 48 56 64 72 80 88
40 48 56 64 72 80 88
44 52 60 68 76 84 92
52 60 68 76 84 92
56 64 72 80 88
64 72 80 88
68 76 84 92
76 84 92
80 88
88
92
• If disease activity was detected at any DAA visit, patients on brolucizumab q12w were adjusted to, and
remained on, a q8w regimen .
• Additional assessments and potential dosing interval adjustments occurred at Weeks 28, 40, 52, 64, 76,
and 88 in HARRIER only
Week

HAWK and HARRIER : Baseline Characteristics Well
Balanced Across Treatment Arms
18

HAWK and HARRIER : Comprehensive pre-
specified primary and key secondary endpoints
19
Primary End
Point
Non-inferiority (NI) to aflibercept in mean BVCA change from baseline to Week 48 (NI
margin, 4.0 letters)
• Average change in BCVA from baseline for the period Week 36–48*/Week 84–96†
• Presence of IRF and/or SRF from baseline at Weeks 16, 48 and 96†
• Disease activity status at Week 16†
• Change in CST from baseline at Weeks 16, 48 and 96†
• Proportion of patients who were maintained on an exclusive q12w interval following the loading phase through
Week 48* and Week 96†
• The predictive value of the first q12w interval for determining successful q12w maintenance at Week 48* and Week
96
Secondary End
Point

HAWK and HARRIER : BCVA change from baseline
to Week 96 Brolucizumab versus Aflibercept
0
2
4
6
8
10
0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96
Brolucizumab 3 mg (n = 358) Brolucizumab 6 mg (n = 360)
Aflibercept 2 mg (n = 360)
Week Brolucizumab 3mg Brolucizumab 6mg Aflibercept 2mg
Week 48 6.1 6.6 6.8
Week 96 5.6 5.9 5.3
Primary Endpoint Secondary Endpoint
 0.5
 0.3
0
2
4
6
8
10
0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96
Brolucizumab 6 mg (n = 370) Aflibercept 2 mg (n = 369)
Week Brolucizumab 6mg Aflibercept 2mg
Week 48 6.6 6.8
Week 96 5.9 5.3
Primary Endpoint
Secondary
Endpoint
 -0.4
• In both HAWK and HARRIER, Brolucizumab met the primary endpoint of non-inferiority for change in BCVA from baseline to
Week 48
• The visual improvements achieved with Brolucizumab were re-affirmed at Week 96 of non – inferiority
Change
from
baseline
in
BCVA,
LS
mean
(SE)
ETDRS
letters

HAWK and HARRIER : Proportion of patients who
gained ≥15 letters from baseline or BCVA of ≥ 84
letters at Week 48
25.9
33.6
25.4
0
5
10
15
20
25
30
35
40
Proportion
of
Patient
%
P = 0.9480* P = 0.0136
29.9
0
5
10
15
20
25
30
35
29.3
P = 0.8600*
Proportion
of
Patient
%
Brolucizumab 3mg
Aflibercept 2mg
Brolucizumab 6 mg
HAWK : 33.6% of the patients gained 15 letters
or more at week 48 compared to 25.4% in
aflibercept group
HARRIER : At week 48 , the percentage of
patients who gained 15 letters or more was
comparable between both the groups

HAWK and HARRIER : Superior reductions in CST
from baseline to Weeks 16 and 48, and 96
-210
-180
-150
-120
-90
-60
-30
0
BL 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96
Brolucizumab 3 mg (n = 358) Brolucizumab 6 mg (n = 360) Aflibercept 2 mg (n = 360)
P=0.0159
Maintenance Phase
P=0.008
P=0.0075
P=0.0012
P=0.0021
P=0.0115
Matched Phase
-210
-180
-150
-120
-90
-60
-30
0
BL 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96
Brolucizumab (n=370) Aflibercept (n=369)
P<0.0001
Matched Phase Maintenance Phase
P<0.0001
P<0.0001
Stable CST was observed in
both HAWK and HARRIER
in the Brolucizumab 6mg
group at all the time points
Patients in the Aflibercept
2mg group had more CST
fluctuations . CST
fluctuations are known to
cause VA drop and fibrosis
development
Graefes Arch Clin Exp Ophthalmol (2011) 249:1635–1642 , Ophthalmology 2020;127:72-84 Dugel PU, Singh RP, Koh A, Ogura Y, Weissgerber G, Gedif K, Jaffe GJ, Tadayoni R, Schmidt-Erfurth U, Holz
FG, HAWK and HARRIER: 96-Week outcomes from the phase trials of brolucizumab for neovascular age-related macular degeneration, Ophthalmology (2020),

Anatomical Outcomes and Its Importance
126 Eyes
Presence of IRC , SRF and PED either led to VA loss or no VA improvement at all time points
SCIeNTIfIC ReporTs | (2019) 9:529

HAWK AND HARRIER : fewer patients on Brolucizumab
had IRF and/or SRF at Weeks 16, 48and 96
42
34
31
34
31
24
52
45
37
0
10
20
30
40
50
60
Week 16 Week 48 Week 96
35%
Patients
with
SRF
and/or
IRF,
%
31%
35%
P=0.003
P<0.0001
P=0.002
P=0.0001
P=0.0688
P=0.0002
29
26 24
45 44
39
0
10
20
30
40
50
Patients
with
SRF
and/or
IRF,
%
P<0.0001 P<0.0001 P<0.0001
36
%
41%
38%
HAWK : at Week 16 , 48, and 96 Brolucizumab
6mg group had 35%, 32%, 35% less patients
who had IRF and /or SRF on OCT than patients
on Aflibercept 2mg group
HARRIER : at Week 16 , 48, and 96
Brolucizumab 6mg group had 36%, 41%, 38%
less patients who had IRF and /or SRF on OCT
than patients on Aflibercept 2mg group
Brolucizumab 3mg
Aflibercept 2mg
Brolucizumab 6 mg

HAWK and HARRIER: similar proportions of patients on
Brolucizumab and Aflibercept had IRF at Weeks16, 48,
and 96
22.3 21.7
19.2
20.3 21.4
15
24.7
22.2
19.9
0
5
10
15
20
25
30
Patients
with
IRF
%
P=0.2012
P=0.0715
P=0.4212
P=0.3896
P=0.7554
P=0.0754
12.4
10.8 10.7
12.3 12.8
10.4
0
2
4
6
8
10
12
14
P=0.9670
P=0.382 P=0.9119
Patients
with
IRF
%
Brolucizumab 3mg
Aflibercept 2mg
Brolucizumab 6 mg
Comparable anatomical outcomes in terms of percentage of patients who had IRF was achieved
with a considerable proportion of brolucizumab 6 mg patients maintained exclusively on a q12w
interval immediately following loading through Week 96

HAWK and HARRIER : fewer patients on
Brolucizumab had SRF at Weeks 16, 48, and 96
26.1
18.3
15.7
17
14.4
24
36.6
30
37
0
5
10
15
20
25
30
35
40
P=0.023
P<0.0001
P=0.003
P=0.003
P=0.0556
P<0.0001
Patients
with
SRF
%
54%
52%
52%
21.2
17.7
15.7
35.4
33.6
30.3
0
5
10
15
20
25
30
35
40
P<0.0001 P<0.0001 P<0.0001
40%
47%
48%
Patients
with
SRF
%
Brolucizumab 3mg
Aflibercept 2mg
Brolucizumab 6 mg
Superior Anatomical outcomes in terms of percentage of patients who had SRF was
achieved with a considerable proportion of brolucizumab 6 mg patients maintained
exclusively on a q12w interval immediately following loading through Week 96

HAWK and HARRIER : fewer patients on Brolucizumab
had sub-RPE fluid at Weeks 16, 48and 96
20
17
14
19
14
11
27
22
15
0
5
10
15
20
25
30
P=0.0271
P=0.0030 P=0.1538
P=0.0035 P=0.9554
P=0.1213
30%
36%
27%
16
13
17
24
22 22
0
5
10
15
20
25
30
P=0.0041 P=0.0007 P=0.0371
33%
41% 23%
Superior Anatomical outcomes in terms of percentage of patients who had Sub –RPE was
achieved with a considerable proportion of brolucizumab 6 mg patients maintained
exclusively on a q12w interval immediately following loading through Week 96
Brolucizumab 3mg
Aflibercept 2mg
Brolucizumab 6 mg

HAWK and HARRIER : Over 50% of Brolucizumab 6 mg
patients maintained on a q12w dosing interval until Week
48
49
56
51
0
10
20
30
40
50
60
Patients
maintained
on
a
q12w
Interval
until
Week
48
a
,
%
Brolucizumab 3mg
Brolucizumab 6 mg
95% Cl (43.9,54.6)
95% Cl (50.2 ,60.8)
95% Cl (45.7 ,56.1)
ANALYSIS SET/APPROACH BROLUCIZUMAB 3mg BROLUCIZUMAB 6mg BROLUCIZUMAB 6mg
FAS/efficacy 50%(44.5,55.3) 57.5% (52.0 62.6) 52.2%(46.8,57.3)
FAS/efficacy +safety 49.4%(43.5,54.6) 55.6%(50.2,60.8) 51.0%(45.7,56.1)
PP+efficacy+safety 49.6%(44.0,54.9) 57%(51.4,62.3) 51.2%(45.8,56.3)
HAWK : 56% of Brolucizumab 6 mg patients
where maintained on q12w dosing at week 48
HARRIER : 51% of Brolucizumab 6 mg patients
where maintained on q12w dosing at week 48

HAWK and HARRIER : 80% of Brolucizumab patients
who completed the first q12w interval remained on
q12w interval until Week 48
16 20 24 28 32 36 40 44 48 .... 96
0 4 8 12
Week
85% (HAWK) and 82% (HARRIER) of Brolucizumab 6 mg
patients remained on a q12w interval
• 56% (HAWK) and 51% (HARRIER) of brolucizumab 6 mg patients maintained on
a q12w interval , If patients were adjusted to a q8w treatment interval at any
DAA visit, they could not revert to q12w
+/-
Disease Activity Assement
48 Primary End Point
16
1st DAA
Patients who successfully completed the
first q12w interval

HAWK and HARRIER : Over 75% of Brolucizumab patients
who completed Week 48 on a q12w interval remained on
q12w interval until Week 96
0 4 8 12 16 20 24 28 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96
Week Primary End Point
32
+/-
• 45% (HAWK) and 39% (HARRIER) of brolucizumab 6 mg patients were maintained on a q12w interval
• If patients were adjusted to a q8w treatment interval at any DAA visit, they could not revert to q12w
• In HARRIER, an additional 4 DAAs were conducted in Year 2
>80% (HAWK) and >75% (HARRIER) of Brolucizumab 6 mg patients
remained on a q12w interval
Disease Activity Assement
48 Primary End Point
16 1st DAA

Summary
Superior VA gains : Brolucizumab was non-inferior to aflibercept for the mean change in BCVA at Week 48 (primary
endpoint)
Long Term Maintenance VA : The BCVA achieved by brolucizumab at Week 48 was maintained at Week 96†
Enhanced Control of Disease Activity : In both HAWK and HARRIER, fewer patients on brolucizumab had IRF
and/or SRF and Sub RPE fluid at Weeks 16, 48 and 96*
Superior Control on Central Retinal Fluctuations : Brolucizumab achieved superior reductions in CST from

Basic Succinct Statement
PAGENAX®
Presentation: Solution for injection. Each vial contains 27.6 mg of brolucizumab in 0.23 mL solution.
Indications: Pagenax is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).
Dosage regimen and administration:
Single-use vial for intravitreal use only. Each vial should only be used for the treatment of a single eye. Pagenax must be administered by a qualified physician.
Adults: The recommended dose for Pagenax is 6 mg (0.05 mL) administered by intravitreal injection every 4 weeks (monthly) for the first three doses. Thereafter, Pagenax is administered every 12 weeks (3 months). The physician may individualize treatment intervals based on disease activity as assessed by visual acuity and/or
anatomical parameters. The treatment interval could be as frequent as every 8 weeks (2 months).
Special populations: ♦Renal impairment: No dose adjustment is required. ♦Hepatic impairment: No dose adjustment is required. ♦Geriatric patients: No dose adjustment is required. ♦Pediatric patients: Safety and efficacy have not been established.
Contraindications: ♦Hypersensitivity to the active substance or to any of the excipients. ♦Active or suspected ocular or periocular infection. ♦Active intraocular inflammation.
Warnings and precautions: ♦Endophthalmitis, retinal detachment, retinal vasculitis and/or retinal vascular occlusion: Intravitreal injections, including those with Pagenax, have been associated with endophthalmitis and retinal detachment. Proper aseptic injection techniques must always be used when administering Pagenax. Retinal
vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of Pagenax. Patients should be instructed to report any symptoms suggestive of the above mentioned events without delay. ♦Intraocular pressure increases: Transient increases in intraocular pressure
have been seen within 30 minutes of injection, similar to those observed with intravitreal administration of other VEGF inhibitors. Sustained intraocular pressure increases have also been reported. Both intraocular pressure and perfusion of the optic nerve head must be monitored and managed appropriately. ♦Driving and using
machines: Patients may experience temporary visual disturbances after an intravitreal injection with Pagenax and the associated eye examination. Advise patients not to drive or use machinery until visual function has recovered sufficiently.
Pregnancy, lactation, females and males of reproductive potential
Pregnancy: The potential risk of use of Pagenax in pregnancy is unknown. However, based on the anti-VEGF mechanism of action, brolucizumab must be regarded as potentially teratogenic and embryo/fetotoxic. Therefore, Pagenax should not be used during pregnancy unless the expected benefits outweighs the potential risks to the
fetus.
Lactation: Breast-feeding is not recommended during treatment and for at least one month after the last dose when stopping treatment with Pagenax.
Females and males of reproductive potential: Women of reproductive potential should use effective contraception (methods that result in less than 1% pregnancy rates) during treatment with Pagenax and for at least one month after the last dose when stopping treatment with Pagenax.
Adverse drug reactions:
Common (1 to 10%): Visual acuity reduced, retinal haemorrhage, uveitis, iritis, vitreous detachment, retinal tear, cataracts, conjunctival haemorrhage, vitreous floaters, eye pain, intraocular pressure increase, conjunctivitis, retinal pigment epithelial tear, vision blurred, corneal abrasion, punctate keratitis, hypersensitivity.
Uncommon (<1%): Endophthalmitis, blindness, retinal artery occlusion, retinal detachment, conjunctival hyperaemia, lacrimation increased, abnormal sensation in eye, detachment of retinal pigment epithelium, vitritis, anterior chamber inflammation, irirodyclitis, anterior chamber flare, corneal oedema, vitreous haemorrhage.
Frequency not known: Retinal vasculitis, retinal vascular occlusion.
Interactions: No formal interaction studies have been performed.
Packs: One 0.23 ml vial, one filter needle
Before prescribing, please consult full prescribing information available from Novartis Healthcare Private Limited, Inspire BKC, Part of 601 & 701, Bandra Kurla Complex, Bandra (East), Mumbai – 400 051, Maharashtra, India. Tel +91 22 50243335/36, Fax +91 22 50243010.
To be sold by retail on the prescription of an Ophthalmologist only.
Promodeck/Retina-HO/Pagenax/65824/xx Aug 2020

Breaking the barriers in the management of neovascular AMD

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Breaking the barriers in the management of neovascular AMD

Similar to Breaking the barriers in the management of neovascular AMD (20)

More from AjayDudani1

More from AjayDudani1 (20)

Recently uploaded

Recently uploaded (20)

Breaking the barriers in the management of neovascular AMD

Editor's Notes