Latest news with #Susvimo
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3 days ago
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Roche extends trials of antibiotic against resistant superbug, FT reports
Roche (RHHBY) is planning to move a new antibiotic into late stage clinical trials after early studies showed it had potential to tackle a common superbug that has become resistant to other treatments, The Financial Times's Hannah Kuchler reports. If successful, it would be the first new class of antibiotic capable of killing acinetobacter or any other 'Gram-negative' bacteria to be developed for more than 50 years, the report says. Roche plans to launch a phase 3 trial for zosurabalpin at the end of the year, or early next year, Kuchler writes. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on RHHBY: Disclaimer & DisclosureReport an Issue Tandem Diabetes, Roche enter patent settlement agreement Roche announces EMA's CHMP has adopted positive opinion for Itovebi Genentech announces two-year follow-up data from STARGLO study Roche's Genentech announces FDA approval of Susvimo for diabetic retinopathy Trump Trade: White House announces 'Golden Dome' missile-defense shield
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23-05-2025
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Pharma Stock Roundup: NVO CEO Resigns, SNY to Buy VIGL & More
This week, Novo Nordisk NVO announced the surprise resignation of its chief executive officer (CEO), Lars Fruergaard Jørgensen. Sanofi SNY announced the proposed acquisition of Vigil Neuroscience, a clinical-stage biotech focused on developing treatments for neurodegenerative diseases. Pfizer PFE announced a licensing deal with Chinese biotech 3SBio. The FDA granted approval to Roche's RHHBY eye drug, Susvimo, for its third indication in the United States. Merck MRK and its Japanese partner Daiichi Sankyo began a pivotal study on ifinatamab deruxtecan in esophageal cancer. Here's a recap of the week's most important stories. Novo Nordisk announced that its CEO, Lars Fruergaard Jørgensen, will step down from his position. The decision can be attributed to increasing competitive pressure and recent market challenges that have led to a decline in the company's stock price since mid-2024. Also, the Novo Nordisk Foundation board asked for a CEO succession and an increased presence on the NVO board. Novo Nordisk Foundation controls the majority of votes at the Novo Nordisk annual general meeting. Accordingly, Lars Rebien Sørensen, chair of the Novo Nordisk Foundation, will join NVO's board as an observer for some time. Jørgensen's decision comes after a mutual agreement with the board, although he will remain in his role temporarily to ensure a smooth transition. Jørgensen has been CEO since 2017 and played a pivotal role in the company's expansion, particularly in the obesity treatment market, which has been a significant growth driver for Novo Nordisk in recent years. Novo Nordisk said a search for Lars Fruergaard Jørgensen's successor has begun. Sanofi announced an agreement to acquire Vigil Neuroscience, which is making innovative TREM2-based therapeutics for neurodegenerative diseases, for a total equity value of around $470 million ($8 per share in cash). The acquisition will add Vigil's investigational oral small-molecule TREM2 agonist, VG-3927, which will be developed in a phase II study for treating Alzheimer's disease. However, Sanofi is not acquiring VGL101, Vigil's second molecule program, which is being developed for another neurodegenerative disease. Pfizer announced an exclusive deal to acquire global (ex-China) rights to SSGJ-707, a bispecific PD-1/VEGF antibody developed by Chinese biotech 3SBio, for an upfront payment of $1.25 billion. The deal includes up to $4.8 billion in milestone payments, tiered double-digit royalties, and a $100 million equity investment in 3SBio. SSGJ-707 is being developed for cancers such as non-small cell lung cancer and metastatic colorectal cancer, with a phase III trial expected this year. Unlike existing PD-1 therapies, SSGJ-707 targets both PD-1 and VEGF, potentially offering a stronger anti-tumor response. The deal is set to be closed in the third quarter. The FDA approved Roche's eye drug, Susvimo, for treating diabetic retinopathy (DR). Susvimo is already approved for treating neovascular or 'wet' age-related macular degeneration and diabetic macular edema. The approval was based on one-year data from the phase III Pavilion study. Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform (a refillable eye implant), offering an alternative treatment option to regular VEGF eye injections for patients at risk of vision loss from progression of diabetic retinopathy. Merck and partner Daiichi Sankyo announced the dosing of the first patient in the pivotal IDeate-Esophageal01 phase III study evaluating the efficacy and safety of ifinatamab deruxtecan (I-DXd) in certain patients with pretreated advanced or metastatic esophageal squamous cell carcinoma versus the physician's choice of chemotherapy. The study's primary endpoint is overall survival. Ifinatamab deruxtecan is also being evaluated in a phase III study in relapsed small cell lung cancer (SCLC). Ifinatamab deruxtecan is a part of Merck's collaboration with Daiichi Sankyo to co-develop and co-commercialize the latter's three DXd antibody drug conjugates or ADCs worldwide, except Japan. The other two ADCs are patritumab deruxtecan/MK-1022 and raludotatug deruxtecan/MK-5909. In August last year, Merck expanded the collaboration to co-develop and co-commercialize MK-6070, an investigational T-cell engager targeting delta-like ligand 3 (DLL3), which it obtained from its acquisition of Harpoon Therapeutics. Pfizer has a Zacks Rank #2 (Buy), while Novo Nordisk, Pfizer, Sanofi and Merck carry a Zacks Rank of 3 (Hold) each. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. The NYSE ARCA Pharmaceutical Index has declined 3.8% in the past five trading sessions. Large Cap Pharmaceuticals Industry 5YR % Return Here's how the eight major stocks performed in the previous five trading sessions. Image Source: Zacks Investment Research In the last five trading sessions, Merck rose the most (4.1%) while Lilly declined the most (2.3%). In the past six months, Novartis rose the most (11.2%), while Novo Nordisk declined the most (34.0%). (See the last pharma stock roundup here: BAYRY Q1 Earnings, NVO & GSK's New Deals) Watch this space for regular pipeline and regulatory updates next week. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY) : Free Stock Analysis Report Roche Holding AG (RHHBY) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
22-05-2025
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FDA approves Roche's Susvimo for diabetic retinopathy
Susvimo can help people with diabetic retinopathy (DR) maintain their vision and prevent progression to blindness with only one treatment every nine months Susvimo's innovative technology via the Port Delivery Platform may offer an alternative to regular eye injections in the US Diabetic retinopathy affects almost 10 million people in the US and is the third FDA-approved indication for Susvimo, which is also approved for treating neovascular or 'wet' age-related macular degeneration and diabetic macular edema Basel, 22 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the US and more than 100 million people globally.1,2 It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months.3,4 Susvimo is now available to US retina specialists and their patients with DR who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. 'The approval of Susvimo for diabetic retinopathy expands treatment options for patients, offering predictable and immediate durability after implantation with only one treatment every nine months,' said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development. 'Many patients with common retinal conditions seek alternative treatment options like Susvimo that can help preserve vision with longer intervals between treatments than regular eye injections.' 'Susvimo is a compelling new treatment for patients at risk of vision loss from progression of diabetic retinopathy,' said vitreoretinal surgeon, Carl Awh, M.D., Tennessee Retina, Tennessee. 'I am delighted to have this far more durable treatment available for my patients.' The FDA decision was based on positive one-year results from the phase III Pavilion study. People with DR who received Susvimo refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS).4 This means there was a reduction in the severity of eye damage caused by diabetes, compared with those under monthly clinical observation who were treated with anti-VEGF injections as needed based on disease progression.4 Additionally, none of the participants receiving Susvimo required supplemental treatment at one year.4 Safety was consistent with the known safety profile for Susvimo.4 Susvimo provides continuous delivery of a customised formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require eye injections as often as once per month.5,6 The Port Delivery Platform is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure, which introduces medicine directly into the eye, addressing certain retinal conditions that can cause vision loss.5,6 Roche is focused on saving people's eyesight from the leading causes of vision loss through pioneering therapies and has the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye conditions. About diabetic retinopathyAccounting for approximately 5% of all cases of visual impairment, diabetic retinopathy (DR) occurs when damage to the blood vessels and the formation of new blood vessels causes blood and/or fluid to leak into the retina - a part of the eye that sends information to the brain, enabling sight.7,8 This leads to swelling, as well as blockage of the blood supply to some areas of the retina.9 As the condition progresses, vision becomes impaired.8 DR affects approximately 103 million people globally, resulting in blindness in almost five million people.2,10 About the Pavilion study11Pavilion (NCT04503551) is a multicentre, randomised, US-based phase III study evaluating the efficacy, safety and pharmacokinetics of Susvimo® (Port Delivery Platform with ranibizumab) 100 mg/mL refilled every nine months compared with people under monthly clinical observation, in 174 people with non-proliferative diabetic retinopathy (DR) without centre-involved diabetic macular edema. Participants were randomised 5:3 to receive either Susvimo with refills every nine months or monthly clinical observation, respectively. In the Susvimo arm, participants received two loading doses of intravitreal ranibizumab, before Susvimo implantation at week 4. The primary endpoint was the proportion of participants with at least a two-step improvement from baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at week 52. Following the primary analysis, participants initially in the clinical observation arm received two ranibizumab loading doses before Susvimo implantation at week 64. About Susvimo® (Port Delivery Platform with ranibizumab) in the USSusvimo 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.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.12 The customised formulation of ranibizumab delivered by 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 US Food and Drug Administration in 2006.13 Roche is also developing DutaFabs – the next generation of bispecific antibodies designed for increased efficacy and durability – tailored for continuous delivery via the Port Delivery implant. About Roche in ophthalmologyRoche 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, which is led by science and informed by insights from people with eye conditions. Our pipeline includes innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema. Applying our extensive experience, we have brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first US Food and Drug Administration-approved refillable eye implant for neovascular or 'wet' age-related macular degeneration (nAMD), diabetic macular edema (DME) and diabetic retinopathy (DR) that continuously delivers a customised formulation of ranibizumab over a period of months.3,6 Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 and vascular endothelial growth factor-A.14-16 Vabysmo is approved around the world for people living with nAMD, DME and macular edema following retinal vein occlusion.16-21 Lucentis® (ranibizumab injection)* was the first treatment approved to improve vision in people with certain retinal conditions.13 About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. 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 *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] Lundeen EA, et al. Prevalence of diabetic retinopathy (DR) in the United States (US) in 2021. JAMA Ophthalmol. 2023 Aug 1;141(8):747-754.[2] Teo ZL, et al. Global prevalence of DR and projection of burden through 2045: systematic review and meta-analysis. Ophthalmology. 2021 Nov;128(11):1580-1591.[3] US Food and Drug Administration (FDA). Highlights of prescribing information, Susvimo. 2021. [Internet; cited April 2025]. Available from: [4] Pieramici D. Port Delivery System (PDS) with ranibizumab in patients with DR: Primary analysis results of the phase III Pavilion trial. Presented at: The Bascom Palmer Eye Institute Angiogenesis, Exudation, and Degeneration Annual Meeting; 2023 Feb 10-11; virtual.[5] National Eye Institute. Injections to treat eye conditions. [Internet; cited April 2025]. Available from: [6] Holekamp N, et al. Archway randomised phase III trial of the PDS with ranibizumab for neovascular age-related macular degeneration (nAMD). Ophthalmology. 2021.[7] Shrestha P et al. Blindness among patients with type II diabetes mellitus presenting to the outpatient department of ophthalmology of a tertiary care centre: a descriptive cross-sectional study. J Nepal Med Assoc. 2022;1;60(254):877-880.[8] National Health Service (NHS). Overview. DR. How diabetes can affect the eyes. [Internet; cited April 2025]. Available from: [9] American Academy of Ophthalmology. Macular edema. [Internet; cited April 2025]. Available from: Harvard Medical School. Department of Ophthalmology. Diabetic eye disease. [Internet; cited April 2025]. Available from: Clinical A multicentre, randomised study in participants with DR without centre-involved diabetic macular edema (DME) to evaluate the efficacy, safety and pharmacokinetics of ranibizumab delivered via the PDS with ranibizumab relative to the comparator arm (Pavilion). [Internet; cited April 2025]. Available from: Heier JS, et al. The angiopoietin/tie pathway in retinal vascular diseases: A review. The Journal of Retinal and Vitreous Diseases. 2021;41:1-19.[13] US FDA. Highlights of prescribing information, Lucentis. 2012. [Internet; cited April 2025]. Available from: [14] Wykoff C, et al. Efficacy, durability and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): Two randomised, double-masked, phase III trials. The Lancet. 2022; 399:741-755.[15] Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for nAMD (TENAYA and LUCERNE): Two randomised, double-masked, phase III, non-inferiority trials. The Lancet. 2022;399:729-40.[16] US FDA. Highlights of prescribing information, Vabysmo. 2024. [Internet; cited April 2025]. Available from: Roche data on file.[18] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. [Internet; cited April 2025]. Available from: Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. [Internet; cited April 2025]. Available from: European Medicines Agency. Summary of product characteristics, Vabysmo. [Internet; cited April 2025]. Available from: Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with retinal vein occlusion. [Internet; cited April 2025]. Available from: Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: Dr Sabine BorngräberPhone: +41 61 68-88027e-mail: Dr Birgit MasjostPhone: +41 61 68-84814e-mail: Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: Attachment Media & Investor Release Susvimo DR FDA EnglishError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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22-05-2025
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FDA Approves Genentech's Susvimo for Diabetic Retinopathy
– Susvimo can help people with diabetic retinopathy (DR) maintain their vision and prevent progression to blindness with only one treatment every nine months – – Susvimo's innovative technology via the Port Delivery Platform may offer an alternative to regular eye injections in the US – – Diabetic retinopathy affects almost 10 million people in the US and is the third FDA-approved indication for Susvimo, which is also approved for treating wet, or neovascular, age-related macular degeneration and diabetic macular edema – SOUTH SAN FRANCISCO, Calif., May 22, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the U.S. and more than 100 million people globally. It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months. Susvimo is now available to U.S. retina specialists and their patients with DR who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. "The approval of Susvimo for diabetic retinopathy expands treatment options for patients, offering predictable and immediate durability after implantation with only one treatment every nine months," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "Many patients with common retinal conditions seek alternative treatment options like Susvimo that can help preserve vision with longer intervals between treatments than regular eye injections." "Susvimo is a compelling new treatment for patients at risk of vision loss from progression of diabetic retinopathy," said vitreoretinal surgeon, Carl Awh, M.D., Tennessee Retina, Tennessee. "I am delighted to have this far more durable treatment available for my patients." The FDA decision was based on positive one-year results from the Phase III Pavilion study. People with DR who received Susvimo refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS). This means there was a reduction in the severity of eye damage caused by diabetes, compared with those under monthly clinical observation who were treated with anti-VEGF injections as needed based on disease progression. Additionally, none of the participants receiving Susvimo required supplemental treatment at one year. Safety was consistent with the known safety profile for Susvimo. Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require eye injections as often as once per month. The Port Delivery Platform is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure, which introduces medicine directly into the eye, addressing certain retinal conditions that can cause vision loss. Genentech is committed to helping people access the medicines they are prescribed and will be offering comprehensive services for people prescribed Susvimo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or Visit for additional information. About Diabetic Retinopathy (DR) Diabetic retinopathy (DR) affects almost 10 million people in the U.S. and more than 100 million people globally, accounting for almost 5% of all cases of blindness. DR can lead to the development of DME, which is a leading cause of vision loss, affecting around 29 million adults worldwide. The longer a person has diabetes, especially if it is poorly controlled, the higher the risk of developing diabetic retinopathy and vision loss. Diabetic retinopathy occurs when blood vessels in the retina become damaged. This can cause vision loss or distortion when the abnormal vessels leak blood or fluid into the eye. About the Pavilion Study Pavilion (NCT04503551) is a multicenter, randomized, U.S.-based Phase III study evaluating the efficacy, safety and pharmacokinetics of Susvimo® (ranibizumab injection) 100 mg/mL refilled every nine months compared with people under monthly clinical observation, in 174 people with diabetic retinopathy without center-involved diabetic macular edema. Participants were randomized 5:3 to receive either Susvimo with refills every nine months or monthly clinical observation, respectively. In the Susvimo arm, participants received two loading doses of intravitreal ranibizumab, before Susvimo implantation at week 4. The primary endpoint was the proportion of participants with at least a two-step improvement from baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at week 52. Following the primary analysis, participants initially in the clinical observation arm received two ranibizumab loading doses before Susvimo implantation at week 64. 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 implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customized formulation of ranibizumab over time. Susvimo is indicated for intravitreal use via the Susvimo eye implant only. 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. Susvimo was previously called the Port Delivery System with ranibizumab in the U.S. The customized formulation of ranibizumab delivered by Susvimo is different from the ranibizumab intravitreal injection, a medicine marketed as Lucentis® (ranibizumab injection), which is approved to treat wet, or neovascular, age-related macular degeneration (AMD) and other retinal diseases. Lucentis was first approved for wet AMD by the FDA in 2006. Genentech is also developing DutaFabs – the next generation of bispecific antibodies designed for increased efficacy and durability – tailored for continuous delivery via the Port Delivery implant. Susvimo Indication SUSVIMO (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is indicated for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor inhibitor medication. Susvimo Important Safety Information WARNING: ENDOPHTHALMITIS The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Warnings and Precautions: The SUSVIMO implant and the procedures associated with inserting, filling, refilling, and (if medically necessary) removing the implant can cause other serious side effects, including: An eye infection (endophthalmitis). Endophthalmitis is an infection of the eyeball that can cause permanent damage to your eye, including blindness. Endophthalmitis requires urgent (same-day) medical or surgical treatment. A missing layer on top of the white part of the eye (conjunctival erosion). Conjunctival erosion is an area that becomes missing (defect) in the layer (conjunctiva) that covers the white part of the eye, which may result in exposure of the implant. Conjunctival erosion may require surgical treatment. An opening of the layer that covers the white part of the eye (conjunctival retraction). Conjunctival retraction is an opening or gaping in the layer (conjunctiva) that covers the white part of the eye, which may cause the implant to be exposed. Conjunctival retraction may require surgical treatment. Tear and separation of layers of the retina (rhegmatogenous retinal detachment). Rhegmatogenous retinal detachment is a tear and separation of one of the layers of the retina in the back of the eye that senses light. Rhegmatogenous retinal detachment requires surgical treatment. Implant movement (implant dislocation): This movement may require surgical treatment to correct. Implant damage: Damage to the implant that prevents continued treatment (refills) with SUSVIMO. If the implant is not able to be properly refilled, a patient's wet AMD may be inadequately treated and a physician may remove the implant and/or change the treatment. Bleeding (vitreous hemorrhage): Vitreous hemorrhage is bleeding within the gel-like substance (vitreous) inside of your eye. This may require an additional eye surgery. Bump on top of the white layer of the eye (conjunctival bleb): conjunctival bleb is a small bulge in the layer (conjunctiva) that covers the white part of the eye where the implant is inserted. This may be due to leakage of fluid from the inside of the eye. This may require medical or surgical treatment. Temporary decrease in vision after the SUSVIMO procedure. Who should not receive SUSVIMO? Patients who have an infection in or around their eye, have active inflammation in their eye, or have had an allergic reaction to ranibizumab or any of its ingredients in SUSVIMO in the past. Information for patients who are of childbearing potential If patients are pregnant, think that they might be pregnant, or plan to become pregnant. It is not known if SUSVIMO will harm an unborn baby. Patients should use birth control (contraception) during treatment with SUSVIMO and for 12 months after the last refill of SUSVIMO. If patients are breastfeeding or plan to breastfeed. SUSVIMO is not recommended during breastfeeding. It is not known if SUSVIMO passes into breast milk. Adverse Reactions The most common adverse reactions were blood on the white of the eye, redness in the white of the eye, sensitivity to light), and eye pain. These are not all the possible side effects of SUSVIMO. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see additional Important Safety Information in the full SUSVIMO Prescribing Information, including BOXED WARNING or visit About Lucentis® (ranibizumab injection) Lucentis® is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. Lucentis is FDA-approved for the treatment of patients with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV). Lucentis was developed by Genentech, a member of the Roche Group. The company retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. Outside the United States, Lucentis is approved in more than 120 countries to treat adult patients with wet AMD, and for the treatment of visual impairment due to DME, due to macular edema secondary to both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), and due to choroidal neovascularization (CNV). Lucentis Important Safety Information Lucentis is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab or any of the excipients in Lucentis. Hypersensitivity reactions may manifest as severe intraocular inflammation. Intravitreal injections, including those with Lucentis, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Increases in intraocular pressure have been noted both pre-injection and post-injection with Lucentis. Although there was a low rate of arterial thromboembolic events (ATEs) observed in the Lucentis clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). Fatal events occurred more frequently in patients with DME and DR at baseline treated monthly with Lucentis compared with control. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded. Retinal vasculitis and/or retinal vascular occlusion have been reported. Patients should be instructed to report any change in vision without delay. In the Lucentis Phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular side effects included nasopharyngitis, anemia, nausea, and cough. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. For additional safety information, please see Lucentis full Prescribing Information, available here: About Genentech in Ophthalmology Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit View source version on Contacts Media Contact: Kendall Tich (650) 467-6800Advocacy Contact: Meg Harrison (617) 694-7060Investor Contacts: Loren Kalm (650) 225-3217Bruno Eschli +41 61 687 5284 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
22-05-2025
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FDA Approves Genentech's Susvimo for Diabetic Retinopathy
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Susvimo ® (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the U.S. and more than 100 million people globally. It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months. Susvimo is now available to U.S. retina specialists and their patients with DR who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. 'The approval of Susvimo for diabetic retinopathy expands treatment options for patients, offering predictable and immediate durability after implantation with only one treatment every nine months,' said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. 'Many patients with common retinal conditions seek alternative treatment options like Susvimo that can help preserve vision with longer intervals between treatments than regular eye injections.' 'Susvimo is a compelling new treatment for patients at risk of vision loss from progression of diabetic retinopathy,' said vitreoretinal surgeon, Carl Awh, M.D., Tennessee Retina, Tennessee. 'I am delighted to have this far more durable treatment available for my patients.' The FDA decision was based on positive one-year results from the Phase III Pavilion study. People with DR who received Susvimo refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS). This means there was a reduction in the severity of eye damage caused by diabetes, compared with those under monthly clinical observation who were treated with anti-VEGF injections as needed based on disease progression. Additionally, none of the participants receiving Susvimo required supplemental treatment at one year. Safety was consistent with the known safety profile for Susvimo. Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require eye injections as often as once per month. The Port Delivery Platform is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure, which introduces medicine directly into the eye, addressing certain retinal conditions that can cause vision loss. Genentech is committed to helping people access the medicines they are prescribed and will be offering comprehensive services for people prescribed Susvimo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or Visit for additional information. About Diabetic Retinopathy (DR) Diabetic retinopathy (DR) affects almost 10 million people in the U.S. and more than 100 million people globally, accounting for almost 5% of all cases of blindness. DR can lead to the development of DME, which is a leading cause of vision loss, affecting around 29 million adults worldwide. The longer a person has diabetes, especially if it is poorly controlled, the higher the risk of developing diabetic retinopathy and vision loss. Diabetic retinopathy occurs when blood vessels in the retina become damaged. This can cause vision loss or distortion when the abnormal vessels leak blood or fluid into the eye. About the Pavilion Study Pavilion (NCT04503551) is a multicenter, randomized, U.S.-based Phase III study evaluating the efficacy, safety and pharmacokinetics of Susvimo ® (ranibizumab injection) 100 mg/mL refilled every nine months compared with people under monthly clinical observation, in 174 people with diabetic retinopathy without center-involved diabetic macular edema. Participants were randomized 5:3 to receive either Susvimo with refills every nine months or monthly clinical observation, respectively. In the Susvimo arm, participants received two loading doses of intravitreal ranibizumab, before Susvimo implantation at week 4. The primary endpoint was the proportion of participants with at least a two-step improvement from baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at week 52. Following the primary analysis, participants initially in the clinical observation arm received two ranibizumab loading doses before Susvimo implantation at week 64. 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 implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customized formulation of ranibizumab over time. Susvimo is indicated for intravitreal use via the Susvimo eye implant only. 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. Susvimo was previously called the Port Delivery System with ranibizumab in the U.S. The customized formulation of ranibizumab delivered by Susvimo is different from the ranibizumab intravitreal injection, a medicine marketed as Lucentis ® (ranibizumab injection), which is approved to treat wet, or neovascular, age-related macular degeneration (AMD) and other retinal diseases. Lucentis was first approved for wet AMD by the FDA in 2006. Genentech is also developing DutaFabs – the next generation of bispecific antibodies designed for increased efficacy and durability – tailored for continuous delivery via the Port Delivery implant. Susvimo Indication SUSVIMO (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is indicated for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor inhibitor medication. Susvimo Important Safety Information WARNING: ENDOPHTHALMITIS The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Warnings and Precautions: The SUSVIMO implant and the procedures associated with inserting, filling, refilling, and (if medically necessary) removing the implant can cause other serious side effects, including: An eye infection (endophthalmitis). Endophthalmitis is an infection of the eyeball that can cause permanent damage to your eye, including blindness. Endophthalmitis requires urgent (same-day) medical or surgical treatment. A missing layer on top of the white part of the eye (conjunctival erosion). Conjunctival erosion is an area that becomes missing (defect) in the layer (conjunctiva) that covers the white part of the eye, which may result in exposure of the implant. Conjunctival erosion may require surgical treatment. An opening of the layer that covers the white part of the eye (conjunctival retraction). Conjunctival retraction is an opening or gaping in the layer (conjunctiva) that covers the white part of the eye, which may cause the implant to be exposed. Conjunctival retraction may require surgical treatment. Tear and separation of layers of the retina (rhegmatogenous retinal detachment). Rhegmatogenous retinal detachment is a tear and separation of one of the layers of the retina in the back of the eye that senses light. Rhegmatogenous retinal detachment requires surgical treatment. Implant movement (implant dislocation): This movement may require surgical treatment to correct. Implant damage: Damage to the implant that prevents continued treatment (refills) with SUSVIMO. If the implant is not able to be properly refilled, a patient's wet AMD may be inadequately treated and a physician may remove the implant and/or change the treatment. Bleeding (vitreous hemorrhage): Vitreous hemorrhage is bleeding within the gel-like substance (vitreous) inside of your eye. This may require an additional eye surgery. Bump on top of the white layer of the eye (conjunctival bleb): conjunctival bleb is a small bulge in the layer (conjunctiva) that covers the white part of the eye where the implant is inserted. This may be due to leakage of fluid from the inside of the eye. This may require medical or surgical treatment. Temporary decrease in vision after the SUSVIMO procedure. Who should not receive SUSVIMO? Patients who have an infection in or around their eye, have active inflammation in their eye, or have had an allergic reaction to ranibizumab or any of its ingredients in SUSVIMO in the past. Information for patients who are of childbearing potential If patients are pregnant, think that they might be pregnant, or plan to become pregnant. It is not known if SUSVIMO will harm an unborn baby. Patients should use birth control (contraception) during treatment with SUSVIMO and for 12 months after the last refill of SUSVIMO. If patients are breastfeeding or plan to breastfeed. SUSVIMO is not recommended during breastfeeding. It is not known if SUSVIMO passes into breast milk. Adverse Reactions The most common adverse reactions were blood on the white of the eye, redness in the white of the eye, sensitivity to light), and eye pain. These are not all the possible side effects of SUSVIMO. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see additional Important Safety Information in the full SUSVIMO Prescribing Information, including BOXED WARNING or visit About Lucentis ® (ranibizumab injection) Lucentis ® is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. Lucentis is FDA-approved for the treatment of patients with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV). Lucentis was developed by Genentech, a member of the Roche Group. The company retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. Outside the United States, Lucentis is approved in more than 120 countries to treat adult patients with wet AMD, and for the treatment of visual impairment due to DME, due to macular edema secondary to both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), and due to choroidal neovascularization (CNV). Lucentis Important Safety Information Lucentis is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab or any of the excipients in Lucentis. Hypersensitivity reactions may manifest as severe intraocular inflammation. Intravitreal injections, including those with Lucentis, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Increases in intraocular pressure have been noted both pre-injection and post-injection with Lucentis. Although there was a low rate of arterial thromboembolic events (ATEs) observed in the Lucentis clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). Fatal events occurred more frequently in patients with DME and DR at baseline treated monthly with Lucentis compared with control. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded. Retinal vasculitis and/or retinal vascular occlusion have been reported. Patients should be instructed to report any change in vision without delay. In the Lucentis Phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular side effects included nasopharyngitis, anemia, nausea, and cough. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. For additional safety information, please see Lucentis full Prescribing Information, available here: About Genentech in Ophthalmology Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases. Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit
