Roche Ophthalmology: Following a Potential $20B Bispecific Blockbuster, Late-Stage Pipeline Gains Momentum

Sep 26, 2023 14:57 CST Updated 14:57

Roche

Oncology Drug Research, Development, and Manufacturing

On September 25, according to the Insight database,Roche's Satralizumab Initiates a New Phase III Clinical Trial in China, TargetingThyroid Eye Disease (TED)(Registration No.:CTR20232982）。

Source: Insight Database Web Version (Unless otherwise specified, the following content is from the same source)

Satralizumab:

Initiate Phase III Clinical Trial for Thyroid Eye Disease

Satralizumab（Enspryng/satralizumab）It is a product layout by Roche.IL-6R monoclonal antibody. Approved by the FDA in August 2020 for the treatment ofNeuromyelitis Optica Spectrum Disorder (NMOSD) adult patients, thereafter, in May 2021, approved for marketing in China,Becoming the first treatment drug for neuromyelitis optica spectrum disorder (NMOSD) in China.

Development Progress of Satralizumab Global Project

ExceptIn addition to neuromyelitis optica, Roche is also exploring other indications, includingTargeting generalized myasthenia gravis (gMG) is already in Phase III clinical trials., wherein the results of the Phase III LUMINESCE study are expected to be released in 2024. Additionally, there are two other studies respectively targetingAutoimmune Encephalitis（AIE）、Myelin Oligodendrocyte Glycoprotein Antibody-Associated Diseases (MOG-AD）The CIELO, METEOROID III phase studies are currently underway.

Source: Roche Investor Day Materials, September 11

And forThyroid Eye Disease (Graves' Ophthalmopathy/TED）According to the Investor Day materials on September 11, Roche registered and initiated two Phase III clinical trials, SatraGo-1 and SatraGo-2, in Q3 this year.

Source: Roche Investor Day Materials, September 11

Currently, according to the Insight database, Roche registered a Phase III clinical trial (Registration No.: ) on the ClinicalTrials.gov platform in July.NCT05987423）, for the treatment of moderate to severe TED patients, currently enrolling 120 participants, with the first subject expected to complete enrollment by the end of this month. In China, clinical approval was granted in July (application number:JXSL2300071), and clinical trials were initiated today.

NCT05987423 Trial Information

Monoclonal Antibodies, Gene Therapy, ASO Therapy…

Ophthalmology Late-Stage Pipeline Takes the Stage

In the field of ophthalmology, Roche has laid out multiple potential blockbuster products.

Star ProductFaricimab (RG7716/Faricimab/Vabysmo) is the world's first bispecific antibody for ophthalmology.Developed using Roche's proprietary CrossMab technology, it can tightly bind to both VEGF-A and angiopoietin (Ang)-2. Compared with commonly used anti-VEGF drugs currently employed for ophthalmic diseases, Faricimab is more long-lasting.

As an ophthalmic drug that was just approved for marketing in January 2022, Vabysmo generated global sales of 591 million Swiss francs in 2022. In just the first half of 2023, its sales reached 957 million Swiss francs, propelling it into the top 8 best-selling products of Roche, with strong growth and tremendous potential.Roche Expects VabysmoSales in 2023 will exceed 20 billion Swiss francs.

In terms of market share, Vabysmo reached 18% in the U.S. neovascular age-related macular degeneration (nAMD) market and 11% in the diabetic macular edema (DME) market in Q2 2023; within one year, its market share exceeded 20% in the UK and Switzerland.

Currently, Roche is also expanding new indications for Vabysmo.In May this year, the FDA accepted the marketing application for the treatment of retinal vein occlusion (RVO), with a PDUFA target review date of December 22.

Source: Roche Investor Day Materials, September 11

Based on the huge market potential in ophthalmology, Roche will further leverage the potential of other ophthalmic products, in addition to actively promotingSatralizumab TreatmentIn addition to the progression of Thyroid Eye Disease (TED), in the late-stage pipeline,Roche has also laid out Another IL-6 monoclonal antibodyRG6179 andSusvimo etc.

IL-6 Monoclonal Antibody:RG6179

RG6179 (RO7200220) is another IL-6 targeted monoclonal antibody developed by Roche. It is currently under clinical development for uveitic macular edema (UME) and diabetic macular edema (DME).

RG6179 Global Project Development Progress

Previously disclosed Phase I clinical DOVETAIL study results provide preliminary data on the safety and efficacy of RG6179 in patients with uveitic macular edema (UME).

DOVETAIL Study Results

Based on this, in December last year, Roche simultaneously registered two items.Phase III Clinical Trials Meerkat and Sandcat for Uveitic Macular Edema (UME)The former completed the enrollment of the first subject in January this year, and the latter in March; both are expected to read out relevant data by 2025.

Among them, the Meerkat trial region includes mainland China, and the domestic part of the research was registered and initiated in July this year (Registration No.: CTR20232119);The Sandcat trial region does not include China.

RG6179 for UME Phase III Clinical Trial

As for DME, it is in Phase II clinical stage.Currently being synchronized and carried outBARDENAS, ALLUVIUM Two ItemsResearch, but the test areas do not include China.

RG6179 Targets DME Phase II Clinical Trial

Susvimo

Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a key role in new blood vessel formation and vascular leakage.

Roche's Susvimo (Ranibizumab PDS Delivery System) implants a refillable port in the patient's eye, which continuously releases the anti-VEGF antibody ranibizumab over a period of several months. This innovation potentially reduces the treatment burden associated with frequent intravitreal injections and enhances the durability of therapeutic effects.

October 2021,Susvimo Approved by the FDA for intravitreal treatment of neovascular or wet age-related macular degeneration (nAMD) patients who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. However, in October 2022, Roche voluntarily recalled the product in the United States due to production issues.Roche previously stated that it had identified the cause and resolved the related issues.

In addition to nAMD, the efficacy of Susvimo has also been validated in other indications.Phase III PAGODA and PAVILLION studies for diabetic macular edema (DME) and diabetic retinopathy (DR) have both achieved positive results.

In addition, Roche plans to restart the Phase IIIb clinical VELODROME trial in Q4 this year, evaluating the refill of Susvimo once every 9 months in nAMD patients.

Source: Roche Investor Day Materials, September 11

In addition, cell therapy and ASO therapy for GA have entered Phase II of clinical development.

Roche Ophthalmology Pipeline

From:Roche September 11 Investor Day Materials

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Meeting Content

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