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VISION GAINS

VABYSMO Delivered Rapid & Sustained Vision Gains With Extended Dosing Intervals at Year 11*

Mean change in BCVA from baseline to week 56 in DME1,10*


Mean change in BCVA from baseline to week 56 in DME (chart)

Primary endpoint was defined as the mean change from baseline in BCVA (measured by the ETDRS letter score) at 1 year (average of weeks 48, 52, and 56) and was tested for non-inferiority using a margin of 4 letters.1

VABYSMO met its primary endpoint vs aflibercept Q8W (FDA-approved dosing regimen)1,3

*After 4 monthly loading doses for the Variable arm and 6 monthly loading doses for the Q8W arm. Minimum interval post-loading phase was Q4W and maximum was Q16W. Extension-of-dosing-interval data are based on medians from the pivotal trials.

BCVA=best corrected visual acuity; DME=diabetic macular edema; ETDRS=Early Treatment Diabetic Retinopathy Study; ITT=intent to treat; LS=least squares; Q4W=every 4 weeks; Q8W=every 8 weeks; Q16W=every 16 weeks.

TREATMENT INTERVALS

Proportion of VABYSMO Patients Achieving Up to Q16W in DME Through Year 11

VABYSMO Variable treatment intervals through week 561,10,12


At week 56, 32% had completed ≥1 Q12W & 1 Q16W interval; 17% were on Q8W and/or Q4W (7% only on Q4W).
  • Sustainability of Q16W interval cannot be determined based on year 1 data alone. The percentages are not generalizable to a broader DME population for a variety  of reasons1
  • The inclusion/exclusion criteria limited enrollment to a select subset of DME patients, and there are no empirical data that a similar magnitude would be observed if eligibility criteria allowed for broader enrollment1
  • The disease activity criteria, which were instrumental in determining dose frequency, were unvalidated. Stricter criteria would have changed how patients were treated, resulting in different percentages of subjects in each dose interval cohort. There was not a similarly dosed aflibercept arm for comparison, which makes the percentages difficult to interpret1

Patients could have received 3 to 11 doses after the loading phase through week 56. Week 52 decision reflects week 56 visit.

After 4 monthly loading doses.1

Similar results were observed in RHINE.10

DME=diabetic macular edema; Q4W=every 4 weeks; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks.

ANATOMICAL OUTCOMES

CST and IRF Were Studied Across All Treatment Arms (Secondary Endpoints)1,10

Change in CST from baseline through week 56 in DME10,12


Changes in CST from baseline through week 56 in DME (chart)

Assessment and Limitations:

Reduction in CST (ILM-BM) over time was a prespecified secondary endpoint. P values (for superiority testing) are nominal and not adjusted for multiplicity; no formal statistical conclusion should be made based on the P values. Clinical significance has not been established, and conclusions regarding treatment effect cannot be drawn.12

Percentage of patients with absence of IRF in DME10,12


Percentage patients with absence of IRF in DME (chart)

Assessment and Limitations:

Absence of IRF was a prespecified secondary endpoint. P values (for superiority testing) are nominal and not adjusted for multiplicity; no formal statistical conclusion should be made based on the P values. Clinical significance has not been established, and conclusions regarding treatment effect cannot be drawn.12

In clinical trials, anatomical outcomes (such as CST and IRF) were used as indicators of underlying disease activity12

An actual patient's CST response: VABYSMO Q8W-Q12W DME Patient


An actual patient’s CST response: VABYSMO Q16W DME Patient


Actual patient OCT scans taken by YOSEMITE & RHINE investigators are representative of the average CST response. Individual results may vary.

CST=central subfield thickness; DME=diabetic macular edema; ILM-BM=inner limiting membrane-Bruch membrane; IRF=intraretinal fluid; ITT=intent to treat; OCT=optical coherence tomography; Q4W=every 4 weeks; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks.

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) and Diabetic Macular Edema (DME). 

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 during the first year was 2% (25 out of 1,262) in patients treated with VABYSMO compared with 2% (14 out of 625) in patients treated with aflibercept.

Adverse Reactions

The most common adverse reaction (≥5%) reported in patients receiving VABYSMO was conjunctival hemorrhage (7%).

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.

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