Intravitreal administration

Berkshire Sterile Manufacturing to Host Webinar on Intravitreal Drug Product Manufacturing

Retrieved on: 
Tuesday, October 31, 2023
Manufacturing, Paratriathlon, CMO, IVT, Contract manufacturing organization, BSM, Pharmaceutical industry, Medical device, Intravitreal administration

Lee, MA, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Berkshire Sterile Manufacturing (BSM) will host a webinar focusing on the manufacturing of Intravitreal (IVT) drug products on Wednesday, November 15 at 1PM EST.

Key Points: 
  • Lee, MA, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Berkshire Sterile Manufacturing (BSM) will host a webinar focusing on the manufacturing of Intravitreal (IVT) drug products on Wednesday, November 15 at 1PM EST.
  • IVT drug products are vital in treating retinal conditions and can potentially prevent, halt, or even reverse damage that may lead to blindness.
  • During the webinar, participants will gain insight into the unique challenges and requirements involved in the manufacturing of IVT drug products.
  • BSM's webinar is designed to offer practical insights and guidance to pharmaceutical professionals in the field of IVT drug product manufacturing.

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

Retrieved on: 
Sunday, July 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.

4DMT Presents Additional Positive Interim Data from Intravitreal 4D-150 Phase 1/2 PRISM Clinical Trial in Patients with Wet AMD at ASRS 2023

Retrieved on: 
Saturday, July 29, 2023
PRISM, Anti-VEGF, Retinal, DME, Clinical trial, AMD, Geographic atrophy, ASRS, Intraocular pressure, Diabetic retinopathy, Cavg, VEGF, SAE, Science, Patient, Intravitreal administration, CST, Annual general meeting, Assessment, FDA, Society, Pharmaceutical industry, Birth control, Vaccine, Veterinary medicine, Electrophysiology

4D-150 is a potentially transformative genetic medicine that utilizes 4DMT’s evolved and customized retinotropic R100 vector, while targeting four VEGF family members.

Key Points: 
  • 4D-150 is a potentially transformative genetic medicine that utilizes 4DMT’s evolved and customized retinotropic R100 vector, while targeting four VEGF family members.
  • 4D-150 is being developed as a single dose, routine outpatient intravitreal therapy with the goal of reducing treatment burden and maintaining efficacy in patients with wet AMD and diabetic macular edema (DME).
  • “We look forward to continuing to build upon 4D-150’s strong profile to date in the randomized Phase 2 stage of the PRISM trial in patients with wet AMD and the Phase 2 SPECTRA trial in patients with DME.
  • cMean ±SE of -0.5 ±2.1 when including all patients (n=10).

Annexon to Report ARCHER Phase 2 Trial Results in Geographic Atrophy at ASRS 2023

Retrieved on: 
Monday, July 24, 2023
Geographic atrophy, Macular degeneration, ARCHER, GA, Patient, Intravitreal administration, Annual general meeting, Webcast, Society, ASRS, Pharmaceutical industry

BRISBANE, Calif., July 24, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (“Annexon”) (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 announced the company will present results from the ongoing ARCHER Phase 2 trial in patients with geographic atrophy (GA) at the American Society of Retina Specialists (ASRS) 2023 Annual Meeting taking place July 28 – August 1, 2023 in Seattle.

Key Points: 
  • BRISBANE, Calif., July 24, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (“Annexon”) (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 announced the company will present results from the ongoing ARCHER Phase 2 trial in patients with geographic atrophy (GA) at the American Society of Retina Specialists (ASRS) 2023 Annual Meeting taking place July 28 – August 1, 2023 in Seattle.
  • The webcast and accompanying slides will be available under the ‘Events & Presentations’ section on the Investors & Media page at www.annexonbio.com.
  • A replay of the webcast will be archived on the Annexon website for 30 days.
  • Dial-in information for conference participants may be obtained by registering for the event here .

Beacon Therapeutics launches with £96 million ($120 million) to develop a new generation of gene therapies for retinal diseases resulting in blindness

Retrieved on: 
Monday, June 12, 2023
BRC, US Foods, Vance DeGeneres, University, AMD, Food, Paratriathlon, Clinical trial, Retinitis pigmentosa, CRD, Retina, GTPase, AAV, IVT, Intravitreal administration, Oxford Sciences Enterprises, Cadherin related family member 3, Nightstar, Protein, Professor, Acquisition, Patient, McLaren, Partnership, VISTA, Knowledge, Entrepreneurship, RPGR, Therapy, FDA, OSE, University of Oxford, Muscular dystrophy, Vaccine, Pharmaceutical industry, Ophthalmology, Beacon

XLRP is predominantly caused by mutations in the retinitis pigmentosa GTPase regulator (RPGR) gene.

Key Points: 
  • XLRP is predominantly caused by mutations in the retinitis pigmentosa GTPase regulator (RPGR) gene.
  • Beacon Therapeutics’s first pre-clinical asset is an intravitreally (IVT) delivered novel AAV based program for dry Age-related Macular Degeneration (dry AMD).
  • Beacon Therapeutics will be led by David Fellows, the former Chief Executive of Nightstar Therapeutics with over 40 years’ experience in the ophthalmology field.
  • Beacon Therapeutics is quite unique in being a company that at launch is already underpinned by excellent clinical trial data.

Homology Medicines Announces First Data from IND-Enabling Studies with GTx-mAb Candidate HMI-104 for PNH, Which Demonstrated Sustained Expression of Functional C5mAb Levels, at the ASGCT Annual Meeting

Retrieved on: 
Tuesday, May 16, 2023
Inhibitor, Neutralizing antibody, Hemolysis, Gene, NOD, MLD, PAH, Serum, SCID, Phenylketonuria, Trabecular meshwork, Gene editing, Gene expression, FIX, Publication, Metachromatic leukodystrophy, Messenger, PKU, Future, Administration, Immunosuppression, Genome, Intravitreal administration, Homologous recombination, Treatment, Vivisection, Immune system, PNH, Cell, Retinal pigment epithelium, NHP, Poster, RPE, Detection, Identification, Virus, ARSA, Society, Vaccine, Pharmaceutical industry, Truffle, Mouse, IND, C5

BEDFORD, Mass., May 16, 2023 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today six presentations supporting its gene editing, gene therapy and GTx-mAb programs at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting, including the first data from IND-enabling studies with HMI-104, the anti-C5 GTx-mAb development candidate for paroxysmal nocturnal hemoglobinuria (PNH). These preclinical data demonstrated that a one-time administration of HMI-104 resulted in sustained expression of C5 monoclonal antibody (C5mAb) levels, supporting the use of a one-time vectorized approach for PNH to enable continuous antibody production.

Key Points: 
  • These preclinical data demonstrated that a one-time administration of HMI-104 resulted in sustained expression of C5 monoclonal antibody (C5mAb) levels, supporting the use of a one-time vectorized approach for PNH to enable continuous antibody production.
  • Additionally, Homology highlighted methods to identify genomic sites with improved homologous-recombination (HR)-based gene editing integration, which could be used to enhance and streamline development of future product candidates.
  • These data support the immunosuppression regimen used in Homology’s ongoing gene editing and gene therapy clinical trials.
  • In the poster, “Gene Therapy Candidate for Metachromatic Leukodystrophy (MLD): Optimization of HMI-202 Leading to HMI-204 Nomination,” Homology highlighted preclinical data on its optimized HMI-204 gene therapy candidate for MLD.

Atsena Therapeutics Receives FDA Clearance of IND Application for ATSN-201, an Investigational Gene Therapy for the Treatment of X-linked Retinoschisis

Retrieved on: 
Monday, May 1, 2023
Male, Research, Paratriathlon, Gene expression, Doctor of Philosophy, Intravitreal administration, Investigational New Drug, Patient, Vivisection, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Pharmaceutical industry, Medical device, RS1

DURHAM, N.C., May 01, 2023 (GLOBE NEWSWIRE) -- Atsena Therapeutics, a clinical-stage gene therapy company focused on bringing the life-changing power of genetic medicine to reverse or prevent blindness, today announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for a Phase I/II clinical trial of ATSN-201 in patients with X-linked retinoschisis (XLRS). ATSN-201 leverages one of the company’s novel spreading capsids, AAV.SPR, to overcome the challenges associated with intravitreally delivered AAVs in the treatment of XLRS.

Key Points: 
  • ATSN-201 leverages one of the company’s novel spreading capsids, AAV.SPR, to overcome the challenges associated with intravitreally delivered AAVs in the treatment of XLRS.
  • “Intravitreally delivered AAVs have limitations, as they do not drive sufficient gene expression in photoreceptors to confer therapy and can lead to vision-compromising inflammation,” said Shannon Boye, PhD, Founder and Director of Atsena Therapeutics.
  • “AAV.SPR is well-suited for use in XLRS as it can drive therapeutic levels of gene expression in photoreceptors while avoiding the surgical risks of foveal detachment, which is important because XLRS patients have fragile retinas due to the presence of schisis lesions.
  • Building on decades of research, we’re excited to progress our novel gene therapy for patients with XLRS who currently lack an approved treatment option.”
    “With the FDA’s clearance of the IND application for ATSN-201, we’re preparing to advance our first program utilizing AAV.SPR into the clinic for the treatment of XLRS in mid-2023,” said Kenji Fujita, Chief Medical Officer of Atsena Therapeutics.

Intravitreal Injectables Global Market Report 2022: Rising Prevalence of Diabetes Fuels Sector Growth - ResearchAndMarkets.com

Retrieved on: 
Wednesday, January 25, 2023
Health, Pharmaceutical, Macular degeneration, Ranibizumab, Smoking, Retinitis, Thrombogenicity, Pharmacotherapy, Diabetic retinopathy, Intravitreal administration, World Health Organization, Obesity, Patient, Allergan, Inc., Bevacizumab, Inflammation, Novartis, Diabetes, Research, Alimera Sciences, Statistics, Endophthalmitis, Atmosphere, CDC, Intravitreal injection, Water pollution, Centers for Disease Control and Prevention, WHO, Bausch Health, Growth, Prevalence, Paratriathlon, Bristol Myers Squibb, Ageing, Video game, Pharmaceutical industry, Lancet

The "Intravitreal Injectables Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2022 to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Intravitreal Injectables Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2022 to 2030" report has been added to ResearchAndMarkets.com's offering.
  • The Intravitreal injectables market will be showcasing stable growth at a compound annual growth rate (CAGR) of 4.8% during the forecast period from 2022 to 2030.
  • In the present situation North America is accountable for 37% market share in the regional segment for Intravitreal injectables market.
  • Rising prevalence of eye disorders and affordable reimbursement scenario drive the market growth in North America.

Age-Related Macular Degeneration (AMD) Global Market Report 2022: Upcoming Treatments to Redefine Sector - ResearchAndMarkets.com

Retrieved on: 
Monday, January 23, 2023
General Health, Health, Optical, Macular degeneration, Insurance, Pharmacy, Paratriathlon, CVS Caremark, Intravitreal administration, Anti-VEGF, Projection, 2052: A Global Forecast for the Next Forty Years, Medicare, Market, AMD, Incidence, Eye, Ageing, UNDESA, Retina, Research, Bevacizumab, Visual impairment, American Ophthalmological Society, Vance DeGeneres, Research report, VEGF, Hospital, Disease, FDA, Luminate, Investment, Macular edema, US, Publishing, Pharmaceutical industry, Sales, Growth, Brolucizumab

Dry macular and wet macular degeneration are the two main types of macula wear and tear leading to the disorder.

Key Points: 
  • Dry macular and wet macular degeneration are the two main types of macula wear and tear leading to the disorder.
  • The potential market for the treatment of age-related macular degeneration is growing in response to rising demand from the elderly.
  • Furthermore, an increase in the occurrence of eye-related disorders and growth in the global elderly population drives the age-related macular degeneration market.
  • In addition, the rising market trends, such as the advancement of gene therapy for age-related macular degeneration, will lead to the development of medical treatment for age-related macular degeneration.

Age-Related Macular Degeneration (AMD) Global Market Report 2022: Sector to Reach $14.6 Billion by 2028 at an 8.5% CAGR

Retrieved on: 
Wednesday, January 25, 2023
Vance DeGeneres, Research report, Investment, VEGF, Macular degeneration, Anti-VEGF, UNDESA, Hospital, Visual impairment, Incidence, Retina, Medicare, Paratriathlon, US, Pharmacy, Insurance, Ageing, FDA, CVS Caremark, Macular edema, 2052: A Global Forecast for the Next Forty Years, Eye, Intravitreal administration, AMD, American Ophthalmological Society, Disease, Luminate, Research, Distribution, Bevacizumab, Projection, Publishing, Pharmaceutical industry, Sales, Brolucizumab, Growth

Age-Related Macular Degeneration Market will reach US$ 14.06 Billion in 2028 according to the publisher.

Key Points: 
  • Age-Related Macular Degeneration Market will reach US$ 14.06 Billion in 2028 according to the publisher.
  • Dry macular and wet macular degeneration are the two main types of macula wear and tear leading to the disorder.
  • As per our research findings Age-related Macular Degeneration Industry will expand at a CAGR of 8.5% from 2022 to 2028.
  • Furthermore, an increase in the occurrence of eye-related disorders and growth in the global elderly population drives the age-related macular degeneration market.