GlobeNewswire by notified

FDA approves Roche’s Susvimo, a first-of-its-kind therapeutic approach for neovascular or “wet” age-related macular degeneration (nAMD)

Share
  • Susvimo, previously called Port Delivery System with ranibizumab, is the first nAMD treatment in 15 years to provide an alternative to standard-of-care eye injections needed as often as once a month
  • By continuously delivering medicine into the eye through a refillable implant, Susvimo may help people with nAMD maintain their vision with as few as two treatments per year
  • Neovascular AMD impacts approximately 20 million people worldwide and is a leading cause of blindness in people over the age of 60

Basel, 22 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with neovascular or “wet” age-related macular degeneration (nAMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Neovascular AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month.1,2,3,4 Susvimo, previously called Port Delivery System with ranibizumab, is the first and only FDA-approved treatment for nAMD that offers as few as two treatments per year.5,6

“Susvimo represents a major advancement in the treatment of retinal disease and is an important new option for patients with wet AMD,” said Carl Regillo, M.D., Chief of Retina Service at Wills Eye Hospital in Philadelphia and an Archway study investigator. “With Susvimo, my patients now have an option that can help them maintain their vision as well as anti-VEGF injections, but on a more manageable twice-yearly treatment schedule.”

Susvimo delivers ranibizumab continuously, offering people living with nAMD an alternative to anti-VEGF eye injections needed as often as once a month.3,4,5 The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months.5,6 If necessary, supplemental ranibizumab treatment can be given to the affected eye while the Susvimo implant is in place.5

“We believe that Susvimo can help people with nAMD preserve their vision while potentially alleviating the treatment burden associated with current standards of care,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Susvimo’s approval builds on Roche’s long-standing commitment to people living with vision-threatening conditions.”

The approval is based on positive results from the phase III Archway study primary analysis, which showed nAMD patients treated with Susvimo achieved and maintained vision gains equivalent to monthly ranibizumab injections – +0.2 and +0.5 eye chart letters from baseline, respectively – at weeks 36 and 40 of treatment. In addition, only 1.6% of Susvimo patients received supplemental ranibizumab treatment before their first refill, and more than 98% could go six months before their first refill.5

In the Archway study, Susvimo was generally well-tolerated, with a favourable benefit-risk profile. However, the Susvimo implant has been associated with a three-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis. In clinical trials, 2.0% of patients receiving a ranibizumab implant experienced at least one episode of endophthalmitis. The most common adverse events (AEs) were conjunctival haemorrhage, conjunctival hyperaemia, iritis and eye pain.6 The safety profile of Susvimo in the clinical trial setting is well understood and will continue to be monitored closely.5

Roche has a robust phase III clinical development programme for Susvimo, including the Portal, Pagoda, Pavilion and Velodrome studies. Portal is an extension study evaluating the long-term safety and efficacy of Susvimo in nAMD.7 Pagoda is evaluating Susvimo for the treatment of people with diabetic macular edema (DME), while Pavilion is a study of Susvimo in diabetic retinopathy without DME.8,9 Velodrome is evaluating Susvimo refilled every nine months in nAMD.10 Susvimo is also currently under review for the treatment of nAMD by the European Medicines Agency (EMA).

Susvimo will be available in the United States in the coming months.

Roche’s late-stage ophthalmology portfolio also includes faricimab, a bispecific antibody under FDA and EMA review for the treatment of nAMD and DME. The FDA is additionally reviewing faricimab for the treatment of diabetic retinopathy.

About the Archway Study5,11,12
Archway (NCT03677934) was a randomised, multicentre, open-label phase III study evaluating the efficacy and safety of Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant administered via the Susvimo eye implant, refilled every six months at fixed intervals, compared to monthly intravitreal injections of ranibizumab 0.5 mg in 415 people living with neovascular or “wet” age-related macular degeneration (nAMD). Patients enrolled in Archway were responders to prior treatment with anti-vascular endothelial growth factor (VEGF) therapy. In both study arms, patients were treated with at least three anti-VEGF injections within the six months prior to their Archway screening visit. The primary endpoint of the study was the change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline at the average of Week 36 and Week 40. Secondary endpoints include safety, overall change in vision (BCVA) from baseline and change from baseline in centre point thickness over time.

According to pre-specified study criteria, Susvimo was shown to be non-inferior and equivalent to monthly ranibizumab injections. On average, patients had received five prior ranibizumab injections before their first study treatment visit. In the Susvimo arm of the study, patients gained an average of 0.2 eye chart letters in visual acuity from baseline compared with 0.5 eye chart letters for the monthly ranibizumab arm. During the first treatment interval, before the first scheduled refill, 1.6% of Susvimo patients assessed (n=4/246) received supplemental ranibizumab treatment, and 98.4% of patients (n=242/246) did not receive supplemental treatment.

In the Archway study, Susvimo was generally well-tolerated, with a favourable benefit-risk profile. The safety profile of Susvimo in the clinical trial setting is well understood and will continue to be monitored closely.

About neovascular age-related macular degeneration
Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading.13 Neovascular or “wet” AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss.1,2 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.2 Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.13, 14, 15

About Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant
Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customised formulation of ranibizumab over time.5 Susvimo is indicated for intravitreal use via the Susvimo eye implant only.6 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 critical role in the formation of new blood vessels and the leakiness of the vessels.4

Susvimo is different from the ranibizumab intravitreal injection, a medicine marketed as Lucentis®* (ranibizumab injection), which is approved to treat neovascular or “wet” age-related macular degeneration (nAMD) and other retinal diseases. Lucentis®️* was first approved for nAMD by the FDA in 2006.16

About Roche in Ophthalmology
Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.

We have the broadest retina pipeline in Ophthalmology, covering early- and late-stage products, which is led by science and informed by insights from people with eye diseases. Our late-stage pipeline includes faricimab, a potential first-of-a-kind treatment being evaluated in a number of retinal conditions including neovascular age-related macular degeneration (nAMD), diabetic macular edema and diabetic retinopathy. Faricimab is the first investigational bispecific antibody designed for the eye.17 It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) – that drive a number of retinal conditions, to stabilise blood vessels, potentially improving vision outcomes for longer.4,17 Our early-stage pipeline includes gene therapies and treatments for geographic atrophy and other vision-threatening diseases, including rare and inherited conditions.

Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss through Lucentis®️* (ranibizumab injection), the first treatment approved to improve

vision in people with certain retinal conditions, and SusvimoTM (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant, the first FDA-approved refillable eye implant for nAMD that continuously delivers a customised formulation of ranibizumab over a period of months.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

*Lucentis® (ranibizumab injection) was developed by Genentech, a member of the Roche Group. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world.

All trademarks used or mentioned in this release are protected by law.

References
[1] Pennington KL, DeAngelis MM. Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3:34.
[2] Little K, et al. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration-the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-91.
[3] Schmidt-Erfurth U, et al. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014;121:193-201.
[4] Heier JS, et al. The Angiopoietin/Tie pathway in retinal vascular diseases: a review. Retina-J Ret Vit Dis. 2021;41:1-19.
[5] Holekamp N, Campochiaro P, et al. Archway Randomized Phase 3 Trial of the Port Delivery System With Ranibizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2021.
[6] FDA. Highlights of prescribing information, Susvimo. 2021
[7] ClinicalTrials.gov. Extension study for the port delivery system with ranibizumab (Portal) [Internet; cited October 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT03683251
[8] ClinicalTrials.gov. This study will evaluate the efficacy, safety, and pharmacokinetics of the port delivery system with ranibizumab in participants with diabetic macular edema compared with intravitreal ranibizumab (Pagoda) [Internet; cited October 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT04108156
[9] ClinicalTrials.gov. A multicenter, randomized study in participants with diabetic retinopathy without center-involved diabetic macular edema to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered via the port delivery system relative to the comparator arm (PAVILION) [Internet; cited October 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT04503551
[10] ClinicalTrials.gov. A study of the efficacy, safety, and pharmacokinetics of a 36-week refill regimen for the Port Delivery System with ranibizumab in patients with neovascular age-related macular degeneration (Velodrome) [Internet; cited October 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT04657289
[11] ClinicalTrials.gov. A phase III study to evaluate the Port Delivery System with ranibizumab compared with monthly ranibizumab injections in participants with wet age-related macular degeneration (ARCHWAY) [Internet; cited October 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT03677934
[12] Regillo C, et al. Port delivery system with ranibizumab (PDS) for nAMD: Updated data from the Archway phase 3 trial. Angiogenesis, Exudation, and Degeneration 2021 Annual Meeting; 2021 February 12–13.
[13] Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures. [Internet; cited October 2021]. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures
[14] Wong WL ,et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. The Lancet Global Health. 2014;2:106-16.
[15] Connolly E, et al. Prevalence of age-related macular degeneration associated genetic risk factors and 4-year progression data in the Irish population. Br J Ophthalmol. 2018;102:1691-95.
[16] FDA. Highlights of prescribing information, Lucentis. 2012 [Internet; cited October 2021]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf
[17] Khan M, et al. Targeting Angiopoietin in retinal vascular diseases: A literature review and summary of clinical trials involving faricimab. Cells. 2020;9:1869.

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Dr. Nicolas Dunant
Phone: +41 61 687 05 17
Patrick Barth
Phone: +41 61 688 44 86

Dr. Barbara von Schnurbein
Phone: +41 61 687 89 67
Karsten Kleine
Phone: +41 61 682 28 31

Nina Mählitz
Phone: +41 79 327 54 74
Nathalie Meetz
Phone: +41 61 687 43 05

Sileia Urech
Phone: +41 79 935 81 48

Roche Investor Relations

Dr. Karl Mahler
Phone: +41 61 68-78503
e-mail: karl.mahler@roche.com
Jon Kaspar Bayard
Phone: +41 61 68-83894
e-mail: jon_kaspar.bayard@roche.com

Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com
Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com

Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Dr. Gerard Tobin
Phone: +41 61 68-72942
e-mail: gerard.tobin@roche.com


Investor Relations North America
Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

JLT Mobile Computers acquires French sales partner ID Work8.12.2021 23:30:00 CET | Press release

With an own sales office JLT strengthens its local presence in the French market, which has grown to become one of the largest and most important regionsin Europe for JLT Växjö, Sweden, 8Dec2021 * * * JLT Mobile Computers, a leading supplier of reliable computers for demanding environments, today announced that they have signed the agreement to acquire of ID Work, their French sales partner with effect from January 2022. Since its start in 2013 ID Work has successfully been driving sales in France through a country-wide network consisting of system integrators and resellers. Since then, the French market has grown to become one of JLT’s largest and most important markets in Europe. JLT will be taking over the business and establish a local sales office with own personnel. Through the acquisition JLT will get closer to its customers and sales partners in France. The founder of ID Work, who is running the company today will have a continued involvement in JLT over the next couple of year

JLT Mobile Computers förvärvar sin franska säljpartner ID Work8.12.2021 23:30:00 CET | Pressemelding

Frankrike är ett av de största och viktigaste länderna i Europa för JLT ochsyftet med förvärvet är att etablera ett säljkontori egen regi för att stärkaden lokala närvaron Växjö, Sverige, 8:e december2021 * * * JLT Mobile Computers, ledande leverantör av stryktåliga datorer för krävande miljöer, annonserar idag att man har tecknat ett avtal om förvärv av sin franska säljpartner ID Work med tillträde i januari 2022. Sedan starten 2013 har ID Work framgångsrikt drivit försäljningen av JLT:s produkter i Frankrike genom ett landstäckande nätverk bestående av systemintegratörer och återförsäljare. Den franska marknaden har sedan dess vuxit till att bli en av JLT:s största och viktigaste marknader i Europa. JLT kommer att ta över ID Works verksamhet och etablera ett säljkontor med egen personal. Förvärvet gör att JLT kommer närmare sina kunder och säljpartners. Grundaren av ID Work som idag driver företaget kommer att ha ett fortsatt engagemang i JLT under de kommande åren. För mer informati

Better Collective initiates share buyback program to cover future payments relating to completed acquisitions and incentive programs8.12.2021 18:00:00 CET | Press release

Regulatory Release no. 38/2021 December 8, 2021 Better Collective A/S (the “Company”) has today initiated a share buyback program for up to 10 mEUR, to be executed during the period from December 9, 2021 to February 24, 2022. The purpose of the buyback program is to cover future payments relating to completed acquisitions and to cover established Incentive Plans. The buyback program is being initiated pursuant to the authorization granted by the shareholders at the annual general meeting held on April 26, 2021 to repurchase up to nominal 4,694,532 shares of EUR 0,01 each of the Company’s share capital in the period until the annual general meeting in 2022. The Company has appointed Nordea as lead manager of the buyback program. Under the agreement with Nordea, Nordea will purchase shares on behalf of the Company and will make its trading decisions independently of, and without influence by the Company. The buyback program is subject to the following terms: The purpose of the program is

Nextensa Nv/sa: Shares Repurchase8.12.2021 17:40:00 CET | Press release

NEXTENSA NV/SA: SHARES REPURCHASE Nextensa NV announces that the board of directors has decided to initiate a share repurchase programme to acquire up to 65,000 shares for a total amount of no more than 4,800,000 euros within the limits set down in the (renewed) share repurchase authorization as granted by the extraordinary general meeting of shareholders of 19 July 2021. The goal of the share repurchase is to enable Nextensa to meet its obligations resulting from the purchase plans for the benefit of its executive management. Nextensa recognizes the need for active and committed managers that are able to guide the transformation into a mixed property investor and developer. Furthermore, based on previous experience and current market practices and trends, the nomination and remuneration committee and the board of directors are convinced that managers are more engaged and committed when they are able to participate in the capital of Extensa NV, as this aligns their interests with those

Millicom files standard form for notification of major holdings8.12.2021 17:13:53 CET | Press release

Millicom files standard form for notification of major holdings Luxembourg,December 8, 2021 – Millicom International Cellular S.A. announced today the CSSF regulatory filing of the form: ANNEX A: Standard form for notification of major holdings (attachment) -END- For further information, please contact Press: Vivian Kobeh, Director Corporate Communications +1-786-628-5300 press@millicom.com Yocasta Valdez, Group Manager Digital Media & Communications +1-305-929-5417 press@millicom.com Investors: Michel Morin, VP Investor Relations +1-786-628-5270 investors@millicom.com Sarah Inmon, Director Investor Relations +1-786-628-5303 investors@millicom.com About Millicom Millicom (NASDAQ U.S.: TIGO, Nasdaq Stockholm: TIGO_SDB) is a leading provider of fixed and mobile services dedicated to emerging markets in Latin America and Africa. Millicom sets the pace when it comes to providing high-speed broadband and innovation around The Digital Lifestyle® services through its principal brand, TIGO. As

Volta Finance Limited - Result of AGM8.12.2021 16:04:30 CET | Press release

8 December 2021 Volta Finance Limited (VTA / VTAS) RESULTS OF THE FIFTEENTH ANNUAL GENERAL MEETING Volta Finance Limited announces that at the Fifteenth Annual General Meeting held earlier today all resolutions proposed were duly passed. One of these resolutions was a special resolution. The full text of the resolutions can be found in the Notice of Meeting contained within the Annual Report and Accounts 2021, copies of which are available for viewing on the Company’s website http://www.voltafinance.com. Further information on the votes cast for each resolution will be available on the Company’s website shortly. CONTACTS For the Investment Manager AXA Investment Managers Paris Serge Demay serge.demay@axa-im.com +33 (0) 1 44 45 84 47 Company Secretary and Administrator BNP Paribas Securities Services S.C.A, Guernsey Branch guernsey.bp2s.volta.cosec@bnpparibas.com +44 (0) 1481 750 853 Corporate Broker Cenkos Securities plc Andrew Worne Daniel Balabanoff +44 (0) 20 7397 8900 ***** ABOUT V

New Kisqali® data shows consistent overall survival benefit across genomic and clinical subtypes of interest in HR+/HER2- metastatic breast cancer8.12.2021 15:30:00 CET | Press release

Data from the MONALEESA Phase III program provide further evidence of the unique profile of Kisqali, the CDK4/6 inhibitor with the longest reported median overall survival (OS) in HR+/HER2- metastatic breast cancer (over 5 years) and proven OS benefit across patient subgroups1-5 Kisqali pooled data at the San Antonio Breast Cancer Symposium confirms OS benefit across most common genomic intrinsic subtypes of HR+/HER2- metastatic breast cancer, including the aggressive, ET-resistant HER2-enriched subtype6 Data supports rationale for HARMONIA, the first prospective, head-to-head Phase III trial seeking to identify the best therapeutic option between Kisqali and Ibrance®* for patients with the HER2-enriched subtype Kisqali remains the only CDK4/6i with consistent OS benefit across the entire MONALEESA program, regardless of site and number of metastases, prior treatment, endocrine partner, line of therapy or menopausal status1-5,7-8 Basel, December 8, 2021 — Novartis today announced new K