• organizations:Genentech
Genentech reports phase 4 Vabysmo data among underrepresented DME patients
Pipeline

Genentech reports phase 4 Vabysmo data among underrepresented DME patients

Study is referred to as the first retinal trial to focus on this patient demographic, finding similar average vision gains to prior research.
Vabysmo provides long-term durability in DME extension study
Research

Vabysmo provides long-term durability in DME extension study

Four-year data finds nearly 80% of patients extended treatment intervals to 3 or 4 months, with 90% reporting absence of DME.
SUSVIMO phase 3 data supports sustained efficacy for DR, DME
Products

SUSVIMO phase 3 data supports sustained efficacy for DR, DME

FDA has also accepted Genentech’s sBLA for the sustained-release drug delivery system’s diabetic eye disease indications.
Genentech's Vabysmo PFS earns FDA approval for retinal diseases
Products

Genentech's Vabysmo PFS earns FDA approval for retinal diseases

Prefilled Syringe version of the bispecific antibody is indicated for treating wet AMD, DME, and RVO.
Genentech is reintroducing SUSVIMO implant for wet AMD in the US
Products

Genentech is reintroducing SUSVIMO implant for wet AMD in the US

Originally FDA approved in 2021, the ocular implant was voluntarily recalled in 2022.
Genentech releases 72-week data on VABYSMO for RVO
Pipeline

Genentech releases 72-week data on VABYSMO for RVO

Long-term results indicate a positive safety profile for the therapy’s third potential indication.
Genentech names interim leader as new CEO
Business

Genentech names interim leader as new CEO

Effective January 1, longtime senior executive Ashley Magargee will take the helm.
FDA approves Vabysmo for RVO
Products

FDA approves Vabysmo for RVO

Approval marks the third indication for Genentech’s faricimab-svoa formulation.
Positive long-term data reported in phase 3 trials of Vabysmo for RVO
Products

Positive long-term data reported in phase 3 trials of Vabysmo for RVO

Treatment has the potential to be the third indication for the FDA-approved drug, joining wet AMD and DME. 
FDA accepts sBLA for Vabysmo to treat RVO
Pipeline

FDA accepts sBLA for Vabysmo to treat RVO

If approved, Vabysmo would become the first bispecific antibody available for blinding retinal conditions.
Genentech reports Vabysmo superiority for retinal drying versus aflibercept  for wet AMD, DME
Research

Genentech reports Vabysmo superiority for retinal drying versus aflibercept for wet AMD, DME

Post hoc analysis supports use of Vabysmo for better blood vessel stability in the macula.
Two-year data released on PDS with ranibizumab for wet AMD
Pipeline

Two-year data released on PDS with ranibizumab for wet AMD

Archway trial continues to support system use as long-term treatment.
Genentech reports positive data in phase 3 trials of Vabysmo for RVO
Pipeline

Genentech reports positive data in phase 3 trials of Vabysmo for RVO

BALATON and COMINO studies both achieved primary endpoints.
Lineage launches phase 2a study by Genentech for GA secondary to AMD
Pipeline

Lineage launches phase 2a study by Genentech for GA secondary to AMD

With no current FDA-approved therapies for geographic atrophy secondary to AMD, RG6501 (OpRegen) could be a game-changer for patients.
Another new FDA approval. — Weekly Glance
Archives

Another new FDA approval. — Weekly Glance

Genentech's Vabysmo just became the first FDA-approved bispecific antibody for ophthalmic use.