Roche On Track To Supplement Relaunched Susvimo’s Label

Having relaunched Susvimo for wet AMD, Roche now has the ocular implant under FDA review for approval in two diabetic ophthalmic indications and presented two-year data in those settings.

DME
Roche hopes to add two diabetes-related eye diseases to the Susvimo label • Source: Shutterstock

Now back on the market as a refillable ocular implant for wet age-related macular degeneration (AMD), Roche Holding AG/Genentech, Inc. ’s Susvimo (ranibizumab injection) may be poised to add indications in diabetic macular edema (DME) and diabetic retinopathy (DR) as Roche seeks to build up the product as a complement to its blockbuster wet AMD, DME and retinal vein occlusion therapy Vabysmo (faricimab).

[Sidebar#SC150558]

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

More from Clinical Trials

  • Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

     
    • By 

    Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

     
    • By 

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

  • Sponsored By:

    Nancy Tests SPARC-931-part

    The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

More from R&D