Benzinga | Jan 31, 2022 05:44AM EST

FDA Approves First Injectable Eye Medicine For Vision Loss Disorder - Genentech's Vabysmo

The FDA has approved Genentech's, a unit of Roche Holdings AG (OTC: RHHBY), Vabysmo (faricimab-svoa) for wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME).

* Vabysmo targets and inhibits two disease pathways linked to several vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).

* Vabysmo is the first and only FDA-approved injectable eye medicine for wet AMD and DME that improves and maintains vision with treatments from one to four months apart in the first year following four initial monthly doses.

* Standard of care for wet AMD and DME typically requires eye injections every one to two months.

* Related content: Benzinga's Full FDA Calendar.

* Vabysmo will be available in the U.S. in the coming weeks.

* The European Medicines Agency is also currently evaluating the Vabysmo Marketing Authorization Application to treat wet AMD and DME.

* The approval is based on positive results across four Phase 3 studies that demonstrated Vabysmo given at intervals of up to four months achieved non-inferior vision gains versus aflibercept given every two months in the first year.

* Vabysmo was generally well tolerated in all four studies, with a favorable benefit-risk profile.

* Price Action: RHHBY shares closed at $48.35 on Friday.