FDA

Vabysmo

Approved 28 Jan 2022IntravitrealInjectable

Indications

VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor indicated for the treatment of patients with: VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.3 )

1.1 Neovascular (wet) Age-Related Macular Degeneration (nAMD)

1.2 Diabetic Macular Edema (DME)

1.3 Macular Edema Following Retinal Vein Occlusion (RVO)

Contraindications

Ocular or periocular infection ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 )

4.1Ocular or Periocular Infections

VABYSMO is contraindicated in patients with ocular or periocular infections.

4.2Active Intraocular Inflammation

VABYSMO is contraindicated in patients with active intraocular inflammation.

4.3Hypersensitivity

VABYSMO is contraindicated 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 may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management. ( 5.1 ) Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. ( 5.2 ) There is a potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition.

( 5.3 )

At a glance

Brand name: Vabysmo
Active substance: faricimab-svoa
Route: Intravitreal
Dosage form: Injectable
Applicant: Genentech Inc
Status: Prescription
FDA approval: 28 Jan 2022
Application: BLA761235-001

Indications

1.1 Neovascular (wet) Age-Related Macular Degeneration (nAMD)

1.2 Diabetic Macular Edema (DME)

1.3 Macular Edema Following Retinal Vein Occlusion (RVO)

Contraindications

Ocular or periocular infection ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 )

4.1Ocular or Periocular Infections

VABYSMO is contraindicated in patients with ocular or periocular infections.

4.2Active Intraocular Inflammation

VABYSMO is contraindicated in patients with active intraocular inflammation.

4.3Hypersensitivity

Warnings and precautions

( 5.3 )

Adverse reactions

The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4) ] Endophthalmitis and retinal detachments [see Warnings and Precautions (5.1) ] Increase in intraocular pressure [see Warnings and Precautions (5.2) ] Thromboembolic events [see Warnings and Precautions (5.3) ] Retinal Vasculitis and/or Retinal Vascular Occlusion [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 5%) reported in patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%).

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed in practice. The data described below reflect exposure to VABYSMO in 2,567 patients, which constituted the safety population in six Phase 3 studies [see Clinical Studies (14.1 , 14.2 , 14.3) ] .

Table 1: Common Adverse Reactions (≥ 1%) Adverse Reactions VABYSMO Active Control (aflibercept) AMD N=664 DME N=1,262 RVO N=641 AMD N=662 DME N=625 RVO N=635 Cataract 3% 15% < 1% 2% 12% 1% Conjunctival hemorrhage 7% 8% 3% 8% 7% 4% Vitreous detachment 3% 5% 2% 3% 4% 2% Vitreous floaters 3% 4% 2% 2% 3% 2% Retinal pigment epithelial tear AMD only 3% 1% Intraocular pressure increased 3% 4% 1% 2% 3% 3% Eye pain 3% 3% < 1% 3% 3% < 1% Intraocular inflammation Including iridocyclitis, iritis, uveitis, vitritis 2% 1% 1% 1% 1% < 1% Eye irritation 1% < 1% < 1% < 1% 1% < 1% Lacrimation increased 1% 1% 0 1% < 1% < 1% Ocular discomfort 1% 1% < 1% < 1% < 1% < 1% Less common adverse reactions reported in < 1% of the patients treated with VABYSMO were corneal abrasion, eye pruritus, ocular hyperemia, blurred vision, sensation of foreign body, endophthalmitis, conjunctival hyperaemia, visual acuity reduced, visual acuity reduced transiently, vitreous hemorrhage, retinal tear and rhegmatogenous retinal detachment.

6.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of VABYSMO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Eye disorders : retinal vasculitis with or without retinal vascular occlusion.

Vabysmo

Indications

Contraindications

4.1Ocular or Periocular Infections

4.2Active Intraocular Inflammation

4.3Hypersensitivity

Warnings and precautions

At a glance

Two medicines in one question?

Vabysmo

Indications

Contraindications

4.1Ocular or Periocular Infections

4.2Active Intraocular Inflammation

4.3Hypersensitivity

Warnings and precautions

At a glance

Two medicines in one question?

5.1Endophthalmitis and Retinal Detachments

5.2Increase in Intraocular Pressure

5.3Thromboembolic Events

5.4Retinal

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information