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Basel, 29 October 2018 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today appear absolute after-effects from the appearance II STAIRWAY abstraction which explored the continued backbone of faricimab (RG7716) in the analysis of neovascular (“wet”) age-related macular decline (nAMD), a arch account of amaurosis globally in bodies age-old 60 and over.[3] At 52 weeks, faricimab patients dosed either every 16 weeks or every 12 weeks accustomed abiding eyes outcomes commensurable to ranibizumab dosed every four weeks. After-effects of the abstraction were presented as a late-breaking articulate presentation during the 2018 American Academy of Ophthalmology`s (AAO) Annual Meeting in Chicago, Illinois, United States. [1]

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“Because accepted anti-VEGF monotherapies for neovascular AMD are burdensome, acute common dispensary visits for eye injections, some bodies are under-treated and acquaintance afterwards crumbling eyes over time,” said Sandra Horning, MD, Roche`s Chief Medical Officer and Head of All-around Product Development. “The STAIRWAY abstracts appearance the abeyant of faricimab to acquiesce beneath injections while accomplishing and comestible the aforementioned beheld assets apparent with a accepted accepted of care. Based on these data, we will be initiating a all-around appearance III programme for faricimab in neovascular AMD.”

STAIRWAY is a 52 anniversary abstraction that adjourned two continued dosing regimens of faricimab 6.0mg accustomed every 16 weeks or every 12 weeks, compared to ranibizumab 0.5 mg every four weeks. At anniversary 24 (three months afterwards the aftermost of four loading doses), patients randomised to faricimab every 16 weeks switched to 12-week dosing if they were apparent to accept alive disease, per pre-defined criteria. At anniversary 24, 65% (n=36/55) of bodies advised with faricimab had no alive disease, highlighting the abeyant of 16 anniversary dosing in about two-thirds of patients. Initial eyes gains, as abstinent by Best Corrected Beheld Acuity (BCVA), were absolutely maintained through to anniversary 52 with both 16 and 12 anniversary dosing regimens. Bodies advised with faricimab dosed every 16 weeks accomplished a beggarly advance of 11.4 belletrist from baseline, compared to 10.1 belletrist in patients advised with faricimab dosed every 12 weeks, and 9.6 belletrist in patients advised with 0.5 mg ranibizumab dosed every four weeks. The three analysis regimens were agnate in both the admeasurement of patients accepting added than 15 belletrist and alienated a accident of added than 15 letters. Commensurable reductions in axial retina array were additionally empiric in bodies advised with both dosing intervals of faricimab and those advised with ranibizumab. [1] Faricimab was able-bodied acceptable with no new assurance signals observed. [1]

In addition, abstracts on the investigational Port Commitment Arrangement with ranibizumab (PDS) in patients with nAMD were additionally presented at the AAO Annual Meeting, absolute added abstracts from the appearance II Ladder study, and the balloon architecture of the appearance III Archway study. [2] The small, refillable eye implant, which is hardly best than a atom of rice, is advised to acquiesce best bodies with nAMD to go six months afterwards defective a refill.

Topline after-effects presented beforehand this year showed the majority of PDS patients – including about 80% of patients in the high-dose PDS accumulation – went six months or best amid the article and the aboriginal appropriate bushing of the device. Importantly, patients in the high-dose PDS accumulation accomplished agnate beheld outcomes as 0.5 mg ranibizumab dosed every four weeks. [4]  Based on abstracts from the appearance II Ladder programme, the cardinal appearance III Archway analytic balloon and the Portal accessible characterization addendum abstraction were accomplished in September 2018. These studies will appraise the ability and assurance of PDS with ranibizumab 100 mg/ml absorption in patients with nAMD at a anchored dosing breach of 24 weeks. [5;6]

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Faricimab and the PDS are the two best avant-garde investigational treatments in Roche`s able-bodied ophthalmology pipeline. In accession to Archway, two cardinal appearance III studies for faricimab are currently accessible and enrolling: RHINE and YOSEMITE. These two studies are advised to investigate the ability and assurance of faricimab compared with aflibercept in bodies with diabetic macular edema (DME). [7;8] Based on STAIRWAY, a all-around appearance III programme for faricimab in nAMD is advancing to arise in 2019.

Follow Roche on Twitter via @Roche and accumulate up to date with AAO 2018 Congress account and updates by application the hashtag #aao2018.

About Neovascular (“wet”) Age-Related Macular DegenerationAMD is a ache that impacts the allotment of the eye that provides sharp, axial eyes bare for activities like reading. [3] Neovascular AMD is an avant-garde anatomy of the ache that can account accelerated and astringent eyes accident and affects 17 actor bodies worldwide. [9;10] It is acquired by the advance of aberrant claret vessels, additionally referred to as choroidal neovascularization (CNV), into the macula. These argosy aperture aqueous and claret and account blister tissue that destroys the axial retina. This action after-effects in a abasement of afterimage over a aeon of months to years.

Current standards of affliction for nAMD ambition vascular endothelial advance agency (VEGF) alone, which finer addresses barge permeability but abandoned partially addresses the anarchic basic of the disease. Furthermore, bodies accepting anti-VEGF analysis may charge as generally as account eye injections, a accountability that can advance to under-treatment of nAMD and, potentially, beneath than optimal eyes outcomes. [11;12] There is a cogent unmet charge for efficacious, longer-lasting therapies for bodies with this condition.

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About STAIRWAY and faricimabFaricimab is the aboriginal bispecific antibiotic advised accurately for intravitreal use to accompanying bind to and neutralise both angiopoietin-2 (Ang-2) and VEGF-A with aerial authority and specificity. In nAMD, Ang-2 works synergistically with VEGF to drive pathologic claret barge permeability and destabilisation, aberrant claret barge advance and aqueous leakage, which accord to eyes loss. Ang-2 additionally plays an important role in assorted aspects of deepening in nAMD. [13;14]

STAIRWAY is a appearance II, multicentre, randomised, comparator-controlled, alongside accumulation analytic balloon investigating the efficacy, assurance and pharmacokinetics of faricimab administered with continued dosing regimens in 76 treatment-naive bodies with nAMD.[1]

About Ladder, Archway and the investigational PDSThe investigational PDS is a small, refillable device, hardly best than a atom of rice, surgically built-in in the eye during a action performed beneath bounded anaesthesia. The PDS is abnormally advised to continuously bear a specialised conception of ranibizumab over time. The PDS contains a customised conception of ranibizumab not accustomed by authoritative authorities. It is altered from the ranibizumab intravitreal injection, a anesthetic marketed as Lucentis® (ranibizumab injection) which is accustomed to amusement nAMD and added retinal diseases.

Ladder is a appearance II, multicentre, randomised, interventional, alive treatment-controlled abstraction advised to appraise the ability and assurance of the PDS in bodies with nAMD who accept ahead responded to analysis with anti-VEGF therapies. [3]

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Archway will appraise the ability and assurance of the PDS in patients with nAMD at a anchored dosing breach of 24 weeks. [5]  In the trial, patients will be randomised into one of two arms: Arm A will accept the PDS 100 mg/mL and refills at anchored 24-week intervals; Arm B will accept account intravitreal injections of ranibizumab 0.5 mg. The primary endpoint of Archway is the change from baseline in BCVA at weeks 36 and 40. Additional abstracts analyses of the Ladder abstraction are advancing and will be presented at approaching medical meetings.

About Roche in ophthalmologyRoche is committed to developing pioneering, transformative therapies for bodies alive with a ambit of eye diseases that account cogent beheld crime and blindness, including nAMD, DME, diabetic retinopathy (DR), geographic decline (GA) and added retinal diseases. Roche is additionally investigating avant-garde platforms for abiding ocular biologic delivery, including the PDS.

Lucentis® (ranibizumab injection) was developed by Genentech, a affiliate of the Roche Group. Genentech retains bartering rights in the United States and Novartis has absolute bartering rights for the blow of the world.

About RocheRoche is a all-around avant-garde in pharmaceuticals and affection focused on advancing science to advance people`s lives. The accumulated strengths of pharmaceuticals and affection beneath one roof accept fabricated Roche the baton in personalised healthcare – a action that aims to fit the appropriate analysis to anniversary accommodating in the best way possible.

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Roche is the world`s bigger biotech company, with absolutely differentiated medicines in oncology, immunology, communicable diseases, ophthalmology and diseases of the axial afraid system. Roche is additionally the apple baton in in vitro affection and tissue-based blight diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to chase for bigger means to prevent, analyze and amusement diseases and accomplish a acceptable accession to society. The aggregation also aims to improve patient admission to medical innovations by alive with all accordant stakeholders. Thirty medicines developed by Roche are included in the Apple Health Organization Model Lists of Essential Medicines, amid them life-saving antibiotics, antimalarials and blight medicines. Moreover, for the tenth afterwards year, Roche has been recognised as the best acceptable aggregation in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is alive in over 100 countries and in 2017 alive about 94,000 bodies worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and acquaint sales of CHF 53.3 billion. Genentech, in the United States, is a wholly endemic affiliate of the Roche Group. Roche is the majority actor in Chugai Pharmaceutical, Japan. For added information, amuse appointment www.roche.com.

All trademarks acclimated or mentioned in this absolution are adequate by law.

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References[1] Khanani AM, et al. Simultaneous Inhibition of VEGF and Ang-2 with Faricimab in Neovascular AMD: STAIRWAY Appearance 2 Results. Presented at the 2018 American Academy of Ophthalmologists (AAO) Annual Meeting; 2018 Oct 26; Chicago, United States.[2] Pieramici D, et al. Port Commitment Arrangement With Ranibizumab (PDS): From Dose Ranging in Ladder Appearance 2 to Archway Appearance 3 Abstraction Design. Presented at the 2018 American Academy of Ophthalmologists (AAO) Annual Meeting; 2018 Oct 27; Chicago, United States.[3] National Institutes of Health Medline Plus. Arch causes of blindness. [Internet; cited 2018 October]. Available from: https://medlineplus.gov/magazine/issues/summer08/articles/summer08pg14-15.html.[4] Awh C, et al. Ladder balloon of the Port Commitment Arrangement for ranibizumab: Initial abstraction results. Presented at the 36th Annual Meeting of the American Association of Retina Specialists (ASRS); 2018 Jul 20-25; Vancouver, British Columbia, Canada.[5] ClinicalTrials.gov. A Appearance III Abstraction to Appraise the Port Commitment Arrangement Implant With Ranibizumab Compared With Account Ranibizumab Injections in Participants With Wet Age-Related Macular Decline (Archway). [Internet; cited 2018 October]. Available from: https://clinicaltrials.gov/ct2/show/study/NCT03677934.[6] ClinicalTrials.gov. Addendum Abstraction for the Port Commitment Arrangement With Ranibizumab (Portal). [Internet; cited 2018 October]. Available from: https://clinicaltrials.gov/ct2/show/NCT03683251.[7] ClinicalTrials.gov. A Abstraction to Appraise the Ability and Assurance of RO6867461 in Participants With Diabetic Macular Edema (RHINE). [Internet; cited 2018 October]. Available from: https://clinicaltrials.gov/ct2/show/NCT03622593.[8] ClinicalTrials.gov. A Abstraction to Appraise the Ability and Assurance of RO6867461 in Participants With Diabetic Macular Edema (YOSEMITE). [Internet; cited 2018 October]. Available from: https://clinicaltrials.gov/ct2/show/NCT03622580.[9] Pennington KL, DeAngelis MM. Epidemiology of age-related macular decline (AMD): associations with cardiovascular ache phenotypes and lipid factors. Eye and Vision. 2016; 3:34.[10] Bright Focus Foundation. Age-related macular degeneration: facts & figures. [Internet; cited 2018 October]. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.[11] Holz FG, Tadayoni R, Beatty S, et al. Multi-country real-life acquaintance of anti-vascular endothelial advance agency analysis for wet age-related macular degeneration. British Journal of Ophthalmology. 2015; 99:220-226.[12] Rao P, Lum F, et al. Real-world eyes in age-related macular decline patients advised with distinct anti-VEGF biologic blazon for 1 year in the IRIS registry. Ophthalmology. 2018; 125: 522-528.[13] Chakravarthy U BC, Brown D, Campochiaro P, et al. Appearance 1 balloon of anti-vascular endothelial advance factor/antiangiopoietin 2 bispecific antibiotic RG7716 for neovascular age-related macular degeneration. Ophthalmology Retina 2017; 1: 474-485[14] Rangasamy S, Srinivasan R, Maestas J, et al. A abeyant role for angiopoietin 2 in the adjustment of the blood-retinal barrier in diabetic retinopathy. Invest Ophthalmol Vis Sci 2011; 52:3784-3791

Roche Accumulation Media RelationsPhone: 41 61 688 8888 / e-mail: [email protected] Nicolas Dunant (Head)- Patrick Barth- Ulrike Engels-Lange- Simone Oeschger- Anja von Treskow

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The issuer of this advertisement warrants that they are alone amenable for the content, accurateness and dness of the advice independent therein.Source: F. Hoffmann-La Roche Ltd via GlobeNewswireHUG#2222425

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