Choroidal neovascularization

Annexon Presents ARCHER Trial Results at ASRS 2023 Highlighting Potential of ANX007 as a Differentiated Treatment for Geographic Atrophy

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Sonntag, Juli 30, 2023
FAF, CNV, AMD, Retinal vasculitis, EM, Geographic atrophy, Macular degeneration, EOM, Patient, Physician, Intravitreal administration, Acute posterior multifocal placoid pigment epitheliopathy, Annual general meeting, Webcast, Paratriathlon, Letter, Visual acuity, Safety, Society, ASRS, Choroidal neovascularization, Communications satellite, Pharmaceutical industry, Medical imaging, Dietary supplement, Birth control, ARCHER

BRISBANE, Calif., July 30, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement-based medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today presented results from the ongoing ARCHER trial in patients with geographic atrophy (GA), underscoring ANX007’s potentially distinct neuroprotective mechanism of action and demonstration of consistent protection from vision loss. Data were presented during an oral presentation titled, “Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration with Intravitreal ANX007: Results of the ARCHER Study,” at the American Society of Retina Specialists (ASRS) 2023 Annual Meeting taking place July 28 – August 1, 2023 in Seattle.

Key Points: 
  • Data were presented during an oral presentation titled, “Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration with Intravitreal ANX007: Results of the ARCHER Study,” at the American Society of Retina Specialists (ASRS) 2023 Annual Meeting taking place July 28 – August 1, 2023 in Seattle.
  • “The results from ARCHER demonstrated dose and time dependent protection of visual function in GA across multiple measures.
  • Annexon conducted additional analyses to further evaluate the effect of ANX007 treatment on BCVA and GA lesion area.
  • The six-month off-treatment follow-up period of the ARCHER trial is ongoing, and Annexon plans to report final results following study conclusion.

Annexon Topline Data from ARCHER Phase 2 Trial of ANX007 in Geographic Atrophy Demonstrated Statistically Significant, Dose-Dependent Preservation of Visual Function

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Mittwoch, Mai 24, 2023
Choroidal neovascularization, LogMAR chart, Male, FAF, B cell, CNV, AMD, Geographic atrophy, Ageing, Paratriathlon, Cell, Female, Iris (anatomy), Complement component 1q, Patient, Physician, Risk, Synapse, RPE, Visual acuity, Caregiver, Safety, Disease, Medical imaging, Pharmaceutical industry, Health insurance, ARCHER

Patients in the pooled treatment group showed a 59% reduction in risk of >15-letter loss (n=181, p=0.008).

Key Points: 
  • Patients in the pooled treatment group showed a 59% reduction in risk of >15-letter loss (n=181, p=0.008).
  • The primary endpoint of mean rate of change (slope) in GA lesion area compared to sham at 12 months did not reach statistical significance.
  • The totality of the data on ANX007 from the ARCHER trial are promising, with the demonstrated preservation of functional vision in GA patients, regardless of their lesion location or size.
  • Preclinical models have demonstrated that inhibition of C1q protects photoreceptor cell synapses, and importantly, photoreceptor cell function.

Skyline Therapeutics to Present at the ASGCT 26th Annual Meeting

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Mittwoch, Mai 3, 2023
SMN, SMA, RNV, Gene, Anti-VEGF, CNV, NAMD, Clinical trial, SMN1, Toxicity, AAV, CNS, DSM-IV codes, IVT, VEGF, Neuromuscular junction, Patient, Kaay Raav Tumhi, Annual general meeting, Cell, NMJ, American Society of Gene and Cell Therapy, Liver, NHP, Therapy, Society, Human, A-DNA, Choroidal neovascularization, Pharmaceutical industry, Vaccine

SHANGHAI, May 3, 2023 /PRNewswire/ -- Skyline Therapeutics, an innovation-driven gene therapy company dedicated to developing unique and novel solutions to address unmet needs in rare and severe diseases, today announced multiple data presentations at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting in Los Angeles, CA, May 16-20, 2023.

Key Points: 
  • SHANGHAI, May 3, 2023 /PRNewswire/ -- Skyline Therapeutics, an innovation-driven gene therapy company dedicated to developing unique and novel solutions to address unmet needs in rare and severe diseases, today announced multiple data presentations at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting in Los Angeles, CA, May 16-20, 2023.
  • SKG0106 is a proprietary AAV vector carrying a transgene genome encoding a novel anti-VEGF protein.
  • Upon delivery, SKG0106 effectively and specifically suppresses the action of human VEGF, a key factor contributing to the pathological angiogenesis in the eyes of nAMD patients.
  • SKG0201 is a novel AAV-mediated gene replacement therapy comprising an optimized human SMN1 cDNA under the control of a unique promoter.

Verana Health's Qdata Geographic Atrophy Links EHR and Imaging Data to Provide a Holistic View of the Patient Journey

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Mittwoch, April 19, 2023
Choroidal neovascularization, Angiopoietin, Abstract, Injection, ARVO, Medical Affairs Bureau, Commercialization, Paratriathlon, Natural history, IRIS, DME, AMD, Faricimab, Eye, Clinical trial, Geographic atrophy, Quality of life, American Academy, Computer vision, American Academy of Ophthalmology, Research, GA, Medicine, Diabetic retinopathy, Genentech, RWD, Millennium, Diagnosis, Forecasting, Machine Intelligence Research Institute, VEGF, HIV disease progression rates, MD, EHR, Machine learning, Visual acuity, Algorithm, Physician, SAN, OCT, Association for Research in Vision and Ophthalmology, Health information management, Disease, Medical imaging, Pharmaceutical industry, Medical device, Nursing, Ophthalmology, Patient

SAN FRANCISCO, April 19, 2023 /PRNewswire/ -- Verana Health®—a digital health company elevating quality in real-world data (RWD)— will announce the development of Qdata® Geographic Atrophy at ARVO 2023, the annual conference of the Association for Research in Vision and Ophthalmology, which takes place in New Orleans between April 23 to 27. This new offering already provides a comprehensive clinical view of real-world data from almost 350,000 de-identified geographic atrophy (GA) patients, making Verana Health the leading company able to identify GA diagnosis from both electronic health records (EHR) and images for research. As Verana Health ingests even more ophthalmic images in 2023, this number will continue to grow.

Key Points: 
  • Combining this image data with EHR data from the American Academy of Ophthalmology (Academy) IRIS® Registry (Intelligent Research in Sight) will support researchers in gaining a comprehensive view into the GA patient journey.
  • Verana Health is the Academy's exclusive end-to-end data curation and analytics partner for the IRIS Registry.
  • Qdata Geographic Atrophy includes de-identified data from more than 8,000 providers and 2,600 GA patients who have linked images and is rapidly growing.
  • In addition to announcing Qdata Geographic Atrophy with Images at ARVO 2023 , Verana Health will present four abstracts:
    1.

Anti-Properdin Antibody (NM3086) Demonstrates Efficacy in a Primate Model of Wet-AMD and Dry-AMD

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Montag, März 6, 2023
AP, Geographic atrophy, Charles River Laboratories, Blood, Complement, Left, Bleeding, Growth, Animal, Choroidal neovascularization, Neovascularization, AMD, Therapy, GA, Retina, Disease, Fluorescein angiography, FDA, CNV, Observation, Pharmaceutical industry, Fibrosis

CLEVELAND, March 06, 2023 (GLOBE NEWSWIRE) -- NovelMed Therapeutics announced today that NM3086, the lead clinical asset in its Properdin-associated Alternative Pathway (AP) program, demonstrated favorable efficacy in an animal model of neovascular age-related macular degeneration (AMD) in rhesus monkeys. This animal model is characterized not only by the abnormal growth of new blood vessels behind the retina, as shown in Figure 1, but also by retinal fibrosis and vascular hemorrhage, which are the critical characteristics of Wet-AMD, Dry-AMD, and GA. While it is difficult to extrapolate the visual acuity score in animals, the damage prevented by NM3086 in this model suggests the drug's efficacy in treating the disease.

Key Points: 
  • The lead drug candidate NM3086 prevented hemorrhage, fibrosis, and neovascularization in a 28-day disease model in rhesus monkeys.
  • While it is difficult to extrapolate the visual acuity score in animals, the damage prevented by NM3086 in this model suggests the drug's efficacy in treating the disease.
  • Figure 1: Fluoresceine angiogram data from three animals treated with NM3086 (bottom) and three that received placebo control.
  • Scientists of Charles River Laboratories established a preclinical Choroidal Neovascularization (CNV) efficacy model in rhesus monkeys.

PrBYOOVIZ™, first PrLUCENTIS® biosimilar, now available in Canada to treat debilitating retinal disorders

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Mittwoch, März 1, 2023
Retina, Visual impairment, Quality of life, Vance DeGeneres, Ranibizumab, DME, CNV, Paratriathlon, Diabetic retinopathy, Neovascularization, Patient, RVO, Health Canada, AMD, Macular edema, Choroidal neovascularization, Biogen, Pharmaceutical industry

"This new treatment option will help meet the growing eye care needs of Canadians living with potentially blinding retinal diseases," said Dr. Keith Gordon, Senior Research Officer, Canadian Council of the Blind.

Key Points: 
  • "This new treatment option will help meet the growing eye care needs of Canadians living with potentially blinding retinal diseases," said Dr. Keith Gordon, Senior Research Officer, Canadian Council of the Blind.
  • "We are delighted that patients who can be treated with anti-VEGF medications now have an alternative treatment available."
  • "Biogen is pleased to deliver a therapeutic alternative that responds to patients' needs while creating opportunities for reallocation of resources to other areas in the health system."
  • The introduction of BYOOVIZ in Canada is bringing biosimilar science to retinal vascular disorders and is the latest development in the evolution of vision health care delivery.

Akari Therapeutics Announces Pre-Clinical Development Progress Toward Potential IND on Long-Acting PAS-Nomacopan for Geographic Atrophy (GA)

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Mittwoch, Februar 15, 2023
Choroid, CNV, LTB4, Vance DeGeneres, Eye, Engineering, Drug discovery, Professor, ARVO, Intravitreal injection, Anxiety, VEGF, VEGF-A, C5, E pluribus unum, Tufts University School of Medicine, Leukotriene B4, Depression, Food, Risk, Choroidal neovascularization, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Endothelium, GMP, Leukotriene, Hot game, Geographic atrophy, American Society for Clinical Investigation, Blood, Therapy, Andrew Conway Ivy, Patient, Incidence, Retina, IVT, Visual system, AAO, Intellectual property, Kinetics, AMD, Inflammation, Medscape, PAS, PEGylation, Injection, McClard, Infection, IND, Pharmaceutical industry, Vaccine, Ophthalmology, Medicare, Akari

PASylation (PAS) technology is a biological alternative to the chemical conjugate polyethylene glycol (PEGylation) in the development of extended half-life recombinant protein therapeutics.

Key Points: 
  • PASylation (PAS) technology is a biological alternative to the chemical conjugate polyethylene glycol (PEGylation) in the development of extended half-life recombinant protein therapeutics.
  • Complement overactivation is a validated target and an important aspect in the pathophysiology of GA, while LTB4 may contribute to overexpression of VEGF-A, a key driver of CNV.
  • “Patients who have geographic atrophy also are at risk of developing an additional sight-threatening condition known as choroidal neovascularization or CNV, which presents more hurdles in the fight to preserve sight.
  • Medscape article on 24-month data presentation at AAO 2022 With Approval Pending, Pegcetacoplan Shows Mixed Results for Treating Geographic Atrophy https://www.medscape.com/viewarticle/981813#vp_2
    McClard CK, et al.

Bausch + Lomb and Modulight Announce FDA Approval of ML6710i Photodynamic Laser for Use with Bausch + Lomb’s VISUDYNE® (Verteporfin for Injection)

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Mittwoch, Februar 1, 2023
Technology, Surgery, Managed Care, Medical Devices, General Health, Science, Clinical Trials, FDA, Biotechnology, Health, Health Technology, Semiconductor, Other Science, Research, Nanotechnology, Other Health, Optical, Bausch & Lomb, Ophthalmology, PDT, IPad, NYSE, AMD, Patient, Food, Choroidal neovascularization, Regulation of tobacco by the U.S. Food and Drug Administration

“PDT continues to be an important treatment option for eye care professionals who are looking to treat patients with predominantly classic subfoveal choroidal neovascularization,” said Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb.

Key Points: 
  • “PDT continues to be an important treatment option for eye care professionals who are looking to treat patients with predominantly classic subfoveal choroidal neovascularization,” said Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb.
  • “With the approval of ML6710i, eye care professionals now have a new state-of-the-art photodynamic laser that addresses a significant unmet need in PDT and is specifically designed to deliver VISUDYNE to patients who suffer from wet AMD with persistent fluid.”
    ML6710i is a modern, easy-to-use and transportable ophthalmic laser that is controlled intuitively from an iPad mobile application.
  • The laser’s beam shaping unit, which can be fit into all common slit lamps used for eye examinations, is formed into a circular, uniform spot to enable efficient treatment delivery of VISUDYNE.
  • “As a result of our efforts with Bausch + Lomb, along with the feedback that many eye care professionals provided to our teams, we are thrilled to bring forward an innovative cloud connected laser platform that the ophthalmology community can use to deliver VISUDYNE to patients in need of treatment of choroidal neovascularization due to AMD,” said Seppo Orsila, founder and CEO, Modulight.

4D Molecular Therapeutics Announces Interim Clinical Data from On-going Phase 1/2 Clinical Trial of Intravitreal 4D-150 for Wet Age-Related Macular Degeneration (wet AMD)

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Montag, November 14, 2022
Clinical trial, Principal, Safety, Security (finance), DME, VEGF, Diabetic retinopathy, Eye, PRISM, Partner (business rank), Blood, Webcast, AAV, Retina, Cystic fibrosis, Conference, Paganini Competition, Clinical research, Choroideremia, CNV, Inflammation, M.A, University, AMD, Fabry disease, Choroidal neovascularization, Molecule, R100, Hallucination, Macular degeneration, Therapy, US, Swelling, Severe cognitive impairment, University of Nevada, Reno, Ophthalmology, Injection, Fabry, Edema, Nobel, RNA interference, Bleeding, Tissue, Risk, Conference call, Cardiology, Scar, Patient, Medical device, Pharmaceutical industry, Vaccine, Placental growth factor

4D Molecular Therapeutics will host a conference call today, Monday November 14, 2022 at 8:00 AM E.T.

Key Points: 
  • 4D Molecular Therapeutics will host a conference call today, Monday November 14, 2022 at 8:00 AM E.T.
  • This clinical data on 4D-150 marks an important milestone for 4DMT, said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.
  • We are developing 4D-150 for the treatment of large and sustainable markets in ophthalmology, including wet AMD and diabetic macular edema.
  • I am looking forward to enrolling patients in the randomized Phase 2 expansion stage of this clinical trial.

4D Molecular Therapeutics Interim Clinical Data from the On-going Phase 1/2 Clinical Trial of 4D-150 for Wet AMD to be Released Monday, November 14, 2022

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Donnerstag, November 10, 2022
Investor, GLOBE, Private Securities Litigation Reform Act, Scar, Hallucination, Infrared spectroscopy correlation table, Risk, U.S. Securities and Exchange Commission, Macular degeneration, Swelling, Choroideremia, Nasdaq, Webcast, Tissue, Blood, Cystic fibrosis, Fabry, Bleeding, Ophthalmology, Therapy, US, Severe cognitive impairment, AMD, Choroidal neovascularization, Safety, RNA interference, VEGF, Molecule, Edema, Retina, Clinical trial, Patient, Security (finance), Cardiology, Percentage, CNV, Fabry disease, Pharmaceutical industry, Vaccine, Placental growth factor

4D Molecular Therapeutics also announced that interim clinical data from cohort 1 of this Phase 1/2 clinical trial will be released at 7:30 am E.T., on Monday, November 14, 2022.

Key Points: 
  • 4D Molecular Therapeutics also announced that interim clinical data from cohort 1 of this Phase 1/2 clinical trial will be released at 7:30 am E.T., on Monday, November 14, 2022.
  • 4D will host a conference call and live webcast on November 14th, 2022, at 8:00 am E.T.
  • 4D Molecular Therapeutics will host a conference call and live webcast on November 14, 2022, at 8:00 am E.T.
  • 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements.