Bispecific antibodies for ophthalmology! Two Phase 3 studies of Vabysmo for retinal vein occlusion (RVO) were successful!

OCTOBER 31, 2022 /BioValleyBIOON/ -- Roche has announced positive top-line results
from two global phase 3 clinical studies (BALATON, COMINO).
The studies evaluated the bispecific antibody Vabysmo (faricimab) for macular edema
caused by retinal branch vein occlusion and central vein occlusion (BRVO and CRVO).
RVO is a sight-threatening disease that affects 28 million people
worldwide.
Vabysmo is the first and currently only bispecific antibody
approved for eye treatment.

Both studies met the primary endpoint: patients who received Vabysmo injections every 4 weeks in the treatment of macular edema due to BRVO and CRVO, and patients who received Eylea injections every 4 weeks (aflibercept, aflibercept, aflibercept) continued treatment for 24 weeks showed non-inferiority in terms of visual improvement
.
In addition, measured using changes in central subfield thickness (CST), vabysmo treatment also led to a rapid reduction in
retinal fluid from baseline to week 24.
In two studies, Vabysmo was generally well
tolerated.
Safety is consistent with
previous trials.

Detailed results of both studies will be presented at an upcoming medical conference and presented to regulatory bodies
around the world.
Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said: "These encouraging data suggest that Vabysmo has the potential to offer a new treatment option for patients with retinal vein occlusion (RVO), a serious retinal vascular disease that can lead to irreversible visual impairment or vision loss
.
Today's results add to the broad evidence
supporting the effectiveness of Vabysmo in treating a variety of retinal diseases.
We look forward to submitting this data to regulators
.
”

Vabysmo is the first bispecific antibody
approved for eye treatment.
To date, Vabysmo has been approved in more than 40 countries around the world for the treatment of visual impairment
caused by neovascular or "wet" age-related macular degeneration (nAMD or wet AMD) and diabetic macular edema (DME).

Standard care for nAMD and DME usually requires eye injections
every 1-2 months.
While anti-vascular endothelial growth factor (VEGF) monotherapy can significantly reduce visual impairment in nAMD and DME patients, the treatment burden associated with frequent eye injections and doctor visits can lead to undertreatment and may lead to suboptimal visual outcomes
.

The approval of Vabysmo marks a significant advance in nAMD and DME treatment, with fewer
injections compared to current standard care.
The long-term efficacy and safety of Vabysmo in the treatment of nAMD and DME has been demonstrated
by 2 years of data from 4 large-scale global studies involving more than 3000 patients.
Vabysmo is the only injectable ophthalmic drug
with a Phase 3 clinical study to support treatment of nAMD and DME patients with up to 4 months apart.
Over time, Vabysmo may be able to improve and maintain vision and anatomy with fewer eye injections
.
As a result, Vabymmo can provide easier treatment planning
for patients, caregivers, and healthcare systems.

Structural features of faricimab (Image source: Roche)

Retinal vein occlusion (RVO) is the second most common cause of vision loss due to retinal vascular disease, affecting about 28 million adults worldwide, mainly those aged 60 years or older, causing severe and sudden vision loss
.
Angiopoietin-2 (Ang-2) levels are elevated in RVO, and increased expression of Ang-2 is thought to lead to disease progression
.

RVO usually causes sudden, painless blindness in the affected eye because a blocked vein restricts normal blood flow to the affected eye's retina, leading to ischemia, bleeding, fluid leakage, and retinal swelling, called macular edema
.
Currently, macular edema caused by RVO is usually treated
with repeated intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs.
There are 2 main types of RVO: (1) retinal branch vein occlusion (BRVO), which affects more than 23 million people worldwide and occurs when one of the four smaller "branches" of the central retinal main vein is blocked; (2) Central retinal vein occlusion (CRVO), which affects more than 4 million people worldwide, occurs when
the central vein of the retina is blocked.

RVO, nAMD, and DME are retinal diseases that are the leading causes of vision loss, affecting about 70 million people
worldwide.

Vabysmo is the first drug to target 2 unique signaling pathways that drive retinal disease, and its active pharmaceutical ingredient faricimab is the first bispecific antibody
specifically designed for the eye.
Unlike current DME and nAMD therapies that inhibit the VEGF pathway, faricimab targets 2 different pathways—via angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A), which drive a variety of retinal diseases (including RVO, nAMD, DME)
that threaten vision.

Ang-2 and VEGF-A lead to vision loss
by disrupting vascular stability, causing the formation of new leaking blood vessels, and increasing the inflammatory response.
By blocking both pathways, faricimab aims to stabilize blood vessels and reduce inflammation and leakage
more than inhibiting either pathway alone.
This may improve vision more than anti-VEGF therapy alone, reducing the frequency of
eye injections required.
(Bio Valley Bioon.
com)

Positive topline phase III results show Roche's Vabysmo improved vision for people living with retinal vein occlusion (RVO)