ophthalmology

FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The US green light for Byooviz (formerly SB11) covers the treatment of wet age-related macular degeneration (AMD) and two …

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Luminopia’s digital therapy for lazy eye aces clinical trial

A digital therapeutic (DTx) for amblyopia – sometimes known as lazy eye – has been shown to improve vision correction over standard therapy in a phase 3 trial, according to its developer Luminopia. The DTx – called Luminopia One – treats amblyopia by getting people with the condition to watch specially modified TV shows and …

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AbbVie spies potential in Regenxbio eye disease gene therapy

AbbVie has expanded its ophthalmology pipeline via a licensing deal with Regenxbio, paying $370 million upfront to get its hands on a gene therapy for wet age-related macular degeneration (AMD) and other eye diseases. The partnership centres on RGX314, which delivers a gene coding for an antibody against VEGF – a well-established approach to treating …

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Apellis reports mixed data with eye drug, but plans to file anyway

Apellis Pharma’s has reported mixed results with its lead drug pegcetacoplan in geographic atrophy (GA) – a major cause of blindness – with one hit and one miss in its phase 3 programme. Shares in the company were hit hard after the news was announced, although Apellis insisted that the totality of the data would …

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Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz

Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the European Commission approved Samsung Bioepis’ copycat drug Byooviz. Byooviz (ranibizumab, also known as SB11) has been cleared for the same indications as Lucentis – including namely wet age-related macular degeneration (AMD) and diabetic macular oedema (DMO – and will …

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Novartis says trials back Beovu safety in diabetic eye disease

There is plenty of evidence that Novartis’ ophthalmology drug Beovu can match its rivals when it comes to efficacy, with less frequent dosing, but the big question facing the company is whether it is less safe. Data from phase 3 trials of the drug in diabetic macular oedema (DMO) provide some encouragement for Novartis on …

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Novartis says trials back Beovu safety in diabetic eye disease

There is plenty of evidence that Novartis’ ophthalmology drug Beovu can match its rivals when it comes to efficacy, with less frequent dosing, but the big question facing the company is whether it is less safe. Data from phase 3 trials of the drug in diabetic macular oedema (DMO) provide some encouragement for Novartis on …

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FDA starts review of Roche’s eye disease drug, setting up 2022 verdict

The FDA has started a priority review of Roche’s bispecific antibody faricimab for two major causes of blindness, preparing for a market showdown with Bayer and Regeneron’s market-leading Eylea. The US regulator will review the drug for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema (DME), as well as diabetic retinopathy …

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Allergen builds case for first drug therapy for presbyopia

If you are in middle aged and find you have to hold your phone at arm’s length to read, you may have presbyopia – a difficulty focusing on close objects that is usually corrected using glasses, contact lenses or laser eye surgery. Now, there could be another alternative, in the form of eye drops administered …

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Dopavision raises €12m for DTx to tackle myopia epidemic

Digital therapeutics (DTx) startup Dopavision has raised funding to develop its lead product, an app designed to slow the progression of myopia – or short-sightedness – in children or adolescents. The €12 million series round, led by Seventure Partners and backed by investors including Novartis, Boehringer Ingelheim and Abbax Health, will be used to fund …

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Biogen’s ambitions in gene therapy hit by another failed pivotal trial

When Biogen acquired Nightstar Therapeutics in 2019, it added a pair inherited retinal disorder (IRD) gene therapies that it hoped would accelerate a push into the fast-evolving category.  Just over two years later, both of those candidates have failed late-stage clinical trials, leaving Biogen’s $800 million investment in Nightstar looking like a poor deal. The …

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Novartis halts three trials of Beovu eye drug on safety concerns

Prospects for Novartis’ ophthalmology drug Beovu have taken another dive after the drugmaker reported toxicity issues in a new phase 3 trial in wet age-related macular degeneration (AMD). On the plus side, Beovu (brolucizumab) met its efficacy objectives in the MERLIN study, but that was offset by higher rates of inflammatory reactions in the eyes …

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Biogen’s eye disease gene therapy fails ahead of FDA Alzheimer’s ruling

Biogen has downbeat news about its gene therapy for the rare inherited eye disease, X-linked retinitis pigmentosa, announcing the shot failed to meet its target in a phase 2/3 study. A final FDA decision on Biogen’s controversial Alzheimer’s drug aducanumab is due before the beginning of next month and the company needs some positive pipeline …

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Aura raises $80m to develop its virus-like cancer drugs

US biotech Aura Biosciences has closed an oversubscribed financing, raising $80 million to help take its lead virus-like drug conjugate (VDC) for a cancer that affects the eye into late-stage development. The Cambridge, Massachusetts-based company is currently testing belzupacap sarotalocan (AU-011) in a phase 2 trial involving patients with choroidal melanoma, a tumour that develops …

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Two biotechs target dry eye disease after Novartis’ Xiidra problems

The pipeline for dry eye disease drugs is beginning to heat up, with two biotechs announcing key developments, aiming to disrupt a market led by Allergan and Novartis. Novartis paid Takeda $3.4 billion for its FDA-approved dry eye drug Xiidra during the Japanese pharma’s merger with Shire in 2019, outlining the sales potential in this …

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UK patient group warns COVID could limit access to Novartis’ new eye drug

NICE has recommended regular NHS funding for Novartis’ long-acting eye drug Beovu (brolucizumab) in England and Wales – but a patient group warned that access could be limited until the pandemic recedes because of disruption to ophthalmology clinics. In final guidance NICE said trials have shown Novartis’ Beovu has similar efficacy in wet advanced macular …

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Roche targets wet AMD with faricimab and its 16-week regimen

Twin late-stage trials of Roche’s ophthalmology drug faricimab have hit the mark in “wet” age-related macular degeneration trial, as the company’s challenge to rivals from Novartis and Bayer strengthens. With faricimab Roche is aiming to outperform rivals in a highly competitive market by doubling the time taken between doses compared with standard care to 16 …

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Roche set to file ophthalmology drug faricimab in DME

Roche looks set to mount a challenge to Bayer’s ophthalmology drug Eylea in 2021 after its faricimab antibody showed comparable results in diabetic macular oedema (DME) but with half the injections, in twin phase 3 studies. While Eylea (aflibercept) is taken in doses eight weeks apart, results from the YOSEMITE and RHINE studies showed faricimab …

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RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

Shots: RetinAI signs a multi-year collaboration with Novartis under which RetinAI’s IT solutions and AI tools will be employed to support multiple projects in ophthalmology and digital health The first project under the agreement will support a multi-center international clinical study involving patients with nAMD. The study is designed to investigate the influence of OCT …

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Novartis signs ophthalmology AI deal with RetinAI

Novartis has signed a multi-year agreement with RetinAI, which will see the companies work together to use artificial intelligence (AI) tools to support ophthalmology and digital health projects. Both companies have already worked on pilot projects in this area. The first project under a new master agreement will involve a multi-centre international clinical study involving …

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Janssen adds Hemera’s AMD gene therapy to pipeline

Johnson & Johnson’s pharma unit Janssen has bought rights to an investigational gene therapy for a severe form age-related macular degeneration from specialist biotech Hemera Biosciences. Financial details of the deal have not been disclosed and will add Hemera’s gene therapy HMR59 to Janssen’s pipeline of ophthalmology drugs. The privately-held biotech has developed the gene …

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Novartis taps smartpatient for app to support wet AMD patients

German digital health company smartpatient is adding a new section of its MyTherapy app providing information on wet age-related macular degeneration (AMD), a leading cause of blindness. The Munich-based company is launching the educational See What’s Next app in collaboration with Novartis, which sells the wet AMD medicines Beovu (brolucizumab) and Lucentis (ranibizumab), and has …

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FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival. Lucentis (ranibizumab) was first FDA approved in 2006 for wet age-related macular degeneration …

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Novartis keeps a close eye on gene therapy with Vedere Bio buy

Already a major player in gene therapy, Novartis has swooped on US startup Vedere Bio in a $280 million deal that builds its position in inherited eye diseases that can lead to blindness. Incubated by Atlas Ventures, Cambridge, Massachusetts Vedere has been flying under the radar since it was founded in 2019 to develop adeno-associated …

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SparingVision raises €44.5m for retinitis pigmentosa gene therapy

French biotech SparingVision has raised 44.5 million euros ($52.7 million) to develop its gene therapy for a rare ocular disease. The round was led by 4BIO Capital and UPMC Enterprises with Jeito Capital and Ysios Capital joining. Current investors Bpifrance and Foundation Fighting Blindness also participated. In a statement, the company said funds will be …

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Samsung Bioepis and Biogen Announce EMA Filling Acceptance of SB11 (biosimilar, Lucentis)

Shots: EMA has accepted to review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). If approved, SB11 will join a growing number of biosimilars developed by Samsung Bioepis and commercialized by Biogen In Nov 2019, Samsung Bioepis announced that it entered into a new commercialization agreement with Biogen for two ophthalmology …

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