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Prescribing Information Prescribing Information Important Safety Information
Important Safety Information Contact Genentech Contact Genentech For Patients &
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 * HOW VABYSMO WORKS
 * nAMD
    * Dosing & Study Design
    * Clinical Data

 * DME
    * Dosing & Study Design
    * Clinical Data

 * RVO
    * Dosing & Study Design
    * Clinical Data

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Prescribing Information Important Safety Information Contact Genentech For
Patients & Caregivers

nAMD Data
DME Data
RVO Data
Financial Support & Resources


VABYSMO® (FARICIMAB-SVOA) IS THE FIRST AND ONLY DUAL-PATHWAY TREATMENT FOR NAMD,
DME, AND RVO2*


POWERFUL FIRST-LINE
EFFICACY2

VABYSMO met its primary endpoint of non-inferiority vs aflibercept 2 mg in the
mean change from baseline in BCVA across nAMD, DME, and RVO2†


RAPID AND SUSTAINED
DRYING1,3,4

VABYSMO achieved CST reductions in all 3 indications over 2 years in DME, 1 year
in nAMD, and 6 months in RVO1,3,4‡


FLEXIBLE 1–4 MONTH
DOSING2

Extended dosing intervals driven by CST and visual acuity in nAMD and DME2§

Monthly dosing for 6 months in RVO2


POWERFUL
FIRST-LINE EFFICACY2

VABYSMO met its primary endpoint of non-inferiority vs aflibercept 2 mg in the
mean change from baseline in BCVA across nAMD, DME, and RVO2†


RAPID AND
SUSTAINED DRYING1,3,4

VABYSMO achieved CST reductions in all 3 indications over 2 years in DME, 1 year
in nAMD, and 6 months in RVO1,3,4‡


FLEXIBLE 1–4
MONTH DOSING2

Extended dosing intervals driven by CST and visual acuity in nAMD and DME2§

Monthly dosing for 6 months in RVO2

*Macular edema following retinal vein occlusion (RVO).

†Primary endpoint was measured by the ETDRS letter score and tested for
non-inferiority using a margin of 4 letters. nAMD: VABYSMO met its primary
endpoint of non-inferiority at year 1 (avg. of weeks 40, 44, and 48).
Differences in LS means for VABYSMO were +0.7 letters (CI: [95%] -1.1, +2.5) in
TENAYA; and 0.0 letters (CI: [95%] -1.7, +1.8) in LUCERNE. DME: VABYSMO met its
primary endpoint of non-inferiority at year 1 (avg. of weeks 48, 52, and 56).
Differences in LS means in YOSEMITE were +0.7 letters (CI: [97.5%] -1.1, +2.5)
for VABYSMO Q4W–Q16W and -0.2 letters (CI: [97.5%] -2.0, +1.6) for VABYSMO Q8W.
Differences in LS means in RHINE were +0.5 letters (CI: [97.5%] -1.1, +2.1) for
VABYSMO Q4W–Q16W and +1.5 letters (CI: [97.5%] -0.1, +3.2) for VABYSMO Q8W. A
non-inferiority margin was not available for year 2. RVO: VABYSMO met its
primary endpoint of non-inferiority at week 24. Differences in LS means for
VABYSMO were -0.6 letters (CI: [95%] -2.2, +1.1) in BALATON; and -0.4 letters
(CI: [95%] -2.5, +1.6) in COMINO.2

‡Reduction in CST over time was a prespecified secondary endpoint. Reductions in
CST were observed across all treatment arms throughout the six Phase 3 studies
in nAMD, DME, and RVO.2

§Recommended dosing is 4 or 6 (DME only) monthly loading doses followed by 1–4
month dosing in nAMD and DME.2




IMPORTANT SAFETY INFORMATION & INDICATIONS

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INDICATIONS

VABYSMO (faricimab-svoa) is a vascular endothelial growth factor (VEGF)
inhibitor and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of
patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD),
Diabetic Macular Edema (DME), and Macular Edema following Retinal Vein Occlusion
(RVO).


IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VABYSMO is contraindicated in patients with ocular or periocular infection, in
patients with active intraocular inflammation, and in patients with known
hypersensitivity to faricimab or any of the excipients in VABYSMO.
Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema,
or severe intraocular inflammation.


WARNINGS AND PRECAUTIONS

ENDOPHTHALMITIS AND RETINAL DETACHMENTS

Intravitreal injections have been associated with endophthalmitis and retinal
detachments. Proper aseptic injection techniques must always be used when
administering VABYSMO. Patients should be instructed to report any symptoms
suggestive of endophthalmitis or retinal detachment without delay, to permit
prompt and appropriate management.


INCREASE IN INTRAOCULAR PRESSURE

Transient increases in intraocular pressure (IOP) have been seen within 60
minutes of intravitreal injection, including with VABYSMO. IOP and the perfusion
of the optic nerve head should be monitored and managed appropriately.

THROMBOEMBOLIC EVENTS

Although there was a low rate of arterial thromboembolic events (ATEs) observed
in the VABYSMO clinical trials, there is a potential risk of ATEs following
intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke,
nonfatal myocardial infarction, or vascular death (including deaths of unknown
cause).

The incidence of reported ATEs in the nAMD studies during the first year was 1%
(7 out of 664) in patients treated with VABYSMO compared with 1% (6 out of 662)
in patients treated with aflibercept.

The incidence of reported ATEs in the DME studies from baseline to week 100 was
5% (64 out of 1,262) in patients treated with VABYSMO compared with 5% (32 out
of 625) in patients treated with aflibercept.

The incidence of reported ATEs in the RVO studies during the first 6 months was
1.1% (7 out of 641) in patients treated with VABYSMO compared with 1.4% (9 out
of 635) in patients treated with aflibercept.

RETINAL VASCULITIS AND/OR RETINAL VASCULAR OCCLUSION

Retinal vasculitis and/or retinal vascular occlusion, typically in the presence
of intraocular inflammation, have been reported with the use of VABYSMO.
Healthcare providers should discontinue treatment with VABYSMO in patients who
develop these events. Patients should be instructed to report any change in
vision without delay.


ADVERSE REACTIONS

The most common adverse reactions (≥5%) reported in patients receiving VABYSMO
were cataract (15%) and conjunctival hemorrhage (8%).


PREGNANCY, LACTATION, FEMALES AND MALES OF REPRODUCTIVE POTENTIAL

Based on the mechanism of action of VEGF and Ang-2 inhibitors, there is a
potential risk to female reproductive capacity, and to embryo-fetal development.
VABYSMO should not be used during pregnancy unless the potential benefit to the
patient outweighs the potential risk to the fetus. The developmental and health
benefits of breastfeeding should be considered along with the mother’s clinical
need for VABYSMO and any potential adverse effects on the breastfed child from
VABYSMO. Females of reproductive potential are advised to use effective
contraception prior to the initial dose, during treatment and for at least 3
months following the last dose of VABYSMO.

You may report side effects to the FDA at (800) FDA-1088 or
www.fda.gov/medwatch. You may also report side effects to Genentech at (888)
835-2555.

Please see additional Important Safety Information in the full VABYSMO
Prescribing Information.



References

 * * Data on file. South San Francisco, CA: Genentech, Inc.
     
     Data on file. South San Francisco, CA: Genentech, Inc.
   
   * VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2023.
     
     VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2023.
   
   * Regula JT, et al. EMBO Mol Med. 2016;8:1265-1288.
     
     Regula JT, et al. EMBO Mol Med. 2016;8:1265-1288.
   
   * Saharinen P, et al. Nat Rev Drug Discov. 2017;16:635-661.
     
     Saharinen P, et al. Nat Rev Drug Discov. 2017;16:635-661.
   
   * Fiedler U, et al. Trends Immunol. 2006;27(12):552-558.
     
     Fiedler U, et al. Trends Immunol. 2006;27(12):552-558.
   
   * Hawighorst T, et al. American Journ of Pathol. 2002;160(4):1381-1392.
     
     Hawighorst T, et al. American Journ of Pathol. 2002;160(4):1381-1392.
   
   * Avery RL, et al. Presented at American Association of Ophthalmology (AAO)
     2022. Sept 30-Oct 03 2022.
     
     Avery RL, et al. Presented at American Association of Ophthalmology (AAO)
     2022. Sept 30-Oct 03 2022.
   
   * Heier J, et al. Lancet. 2022;399(10326):729-740.
     
     Heier J, et al. Lancet. 2022;399(10326):729-740.
   
   * Guymer R, et al. Presented at Angiogenesis, Exudation, and Degeneration
     2022. Feb 11-12 2022.
     
     Guymer R, et al. Presented at Angiogenesis, Exudation, and Degeneration
     2022. Feb 11-12 2022.
   
   * Wykoff C, et al. Lancet. 2022;399(10326):741-755.
     
     Wykoff C, et al. Lancet. 2022;399(10326):741-755.
   
   * Heier JS, et al. Presented at American Academy of Ophthalmology Retina
     Subspecialty Day (AAO-SSD) 2021. Nov 12-13 2021.
     
     Heier JS, et al. Presented at American Academy of Ophthalmology Retina
     Subspecialty Day (AAO-SSD) 2021. Nov 12-13 2021.
   
   * Goldberg R, et al. Presented at the Association for Research in Vision and
     Ophthalmology (ARVO) 2023. April 23-27 2023.
     
     Goldberg R, et al. Presented at the Association for Research in Vision and
     Ophthalmology (ARVO) 2023. April 23-27 2023.
   
   * Baumal CR, et al. Presented at the Association for Research in Vision and
     Ophthalmology (ARVO) 2022. May 1-4 2022.
     
     Baumal CR, et al. Presented at the Association for Research in Vision and
     Ophthalmology (ARVO) 2022. May 1-4 2022.
   
   * Khanani AM, et al. JAMA Ophthalmol. 2020;138(9):964-972.
     
     Khanani AM, et al. JAMA Ophthalmol. 2020;138(9):964-972.
   
   * Sahni J, et al. Ophthalmology. 2019;126(8):1155-1170.
     
     Sahni J, et al. Ophthalmology. 2019;126(8):1155-1170.
   
   * Khanani AM, et al. JAMA Ophthalmol. 2020;138(9):964-972.
     
     Khanani AM, et al. JAMA Ophthalmol. 2020;138(9):964-972.
   
   * Sahni J, et al. Ophthalmology. 2019;126(8):1155-1170.
     
     Sahni J, et al. Ophthalmology. 2019;126(8):1155-1170.
   
   * Goldberg R, et al. Presented at the Association for Research in Vision and
     Ophthalmology (ARVO) 2023. April 23-27 2023.
     
     Goldberg R, et al. Presented at the Association for Research in Vision and
     Ophthalmology (ARVO) 2023. April 23-27 2023.
   
   * Tadayoni R, et al. Presented at Angiogenesis, Exudation, and Degeneration
     2023. Feb 10-11 2023.
     
     Tadayoni R, et al. Presented at Angiogenesis, Exudation, and Degeneration
     2023. Feb 10-11 2023.

 * * Baumal CR, et al. Presented at American Academy of Ophthalmology (AAO)
     2022. Sep 30-Oct 03 2022.
     
     Baumal CR, et al. Presented at American Academy of Ophthalmology (AAO)
     2022. Sep 30-Oct 03 2022.
   
   * Tadayoni R, et al. Presented at Angiogenesis, Exudation, and Degeneration
     2023. Feb 10-11 2023.
     
     Tadayoni R, et al. Presented at Angiogenesis, Exudation, and Degeneration
     2023. Feb 10-11 2023.



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