NAMD

Adverum Biotechnologies Announces Upcoming Data Presentation at AAO 2022

Retrieved on: 
Friday, September 23, 2022
American Academy, Retina, AAO, Safety, Incidence, IRF, OPTIC, Prevalence, Neovascularization, Publication, Annual general meeting, Compliance, IVT, Late, NAMD, Patient, SRF, Standard of care, Severe cognitive impairment, Nasdaq, NASDAQ, Research, AMD, GLOBE, American Academy of Ophthalmology, Macular degeneration, Pharmaceutical industry, Adverum Biotechnologies

Oral Presentation Title: ADVM-022 Intravitreal Gene Therapy for Neovascular AMD: OPTIC Phase 1 Study Update

Key Points: 
  • Oral Presentation Title: ADVM-022 Intravitreal Gene Therapy for Neovascular AMD: OPTIC Phase 1 Study Update
    Adverum intends to issue a press release concurrent with the presentation and to post the data presented on the Publications page in the Pipeline section of the companys website.
  • Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD, affecting approximately 10% of patients living with AMD.
  • The incidence of new cases of wet AMD is expected to grow significantly worldwide as populations age.
  • ADVM-022, ixoberogene soroparvovec (Ixo-vec), is Adverums clinical-stage gene therapy product candidate being developed for the treatment of wet AMD.

Global Macular Degeneration Treatment Market to 2028 - Featuring Bayer, Pfizer, Novartis and Aerie Pharmaceutical Among Others - ResearchAndMarkets.com

Retrieved on: 
Friday, September 23, 2022
Pharmaceutical, Health, Optical, Center, Retina, Prevalence, FDA, Ranibizumab, Growth, Novartis, Industry, Bayer, Severe cognitive impairment, NAMD, CDC, US, Korea Disease Control and Prevention Agency, Ageing, Marketing, CAGR, Pharmaceutical industry, Publishing

It profiles key players in the global macular degeneration treatment market based on the following parameters such as company highlights, products portfolio, key highlights, financial performance, and strategies.

Key Points: 
  • It profiles key players in the global macular degeneration treatment market based on the following parameters such as company highlights, products portfolio, key highlights, financial performance, and strategies.
  • The global macular degeneration treatment market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts.
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global macular degeneration treatment market.
  • Global Macular Degeneration Treatment Market, By Type:
    Global Macular Degeneration Treatment Market, By Stage of Disease:

Adverum Biotechnologies Announces First Subject Dosed with Ixo-vec in the Phase 2 LUNA Trial for the Treatment of Wet Age-Related Macular Degeneration

Retrieved on: 
Wednesday, September 14, 2022
Retina, Inflammation, Safety, Injection, Incidence, OPTIC, Prevalence, European Medicines Agency, Neovascularization, Week, Hope, Orange County, Compliance, IVT, Private Securities Litigation Reform Act, VEGF, Severe cognitive impairment, Maintenance, NAMD, Patient, CST, U.S. Securities and Exchange Commission, Technology, Standard of care, Nasdaq, NASDAQ, Research, AMD, GLOBE, Dexamethasone, SEC, Macular degeneration, Pharmaceutical industry, Vaccine, Adverum Biotechnologies

REDWOOD CITY, Calif., Sept. 14, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that the first subject was dosed in the LUNA Phase 2 trial evaluating ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) for the treatment of wet age-related macular degeneration (wet AMD).

Key Points: 
  • The trial is designed to assess the safety and efficacy of two dose levels of a single, in-office intravitreal injection of Ixo-vec for the treatment of wet AMD.
  • The LUNA trial is a double-masked, randomized, Phase 2 trial being conducted at approximately 40 sites in the U.S. and Europe.
  • LUNA will evaluate Ixo-vec in subjects with wet AMD who are 50 years or older and have demonstrated a response to anti-VEGF treatment.
  • The LUNA trial primary endpoints are mean change in BCVA from baseline to one year and the incidence and severity of adverse events.

Genentech's Vabysmo Slowly Chips Away at Competition in the Neovascular (Wet) AMD Market While Regeneron's Eylea Holds its Ground (For Now), According to New Spherix Report

Retrieved on: 
Thursday, September 1, 2022
Patient, Regeneron Pharmaceuticals, Traction, Biosimilar, Samsung, NAMD, Physician, Nephrology, Neovascularization, Ophthalmology, PDS, FDA, Ranibizumab, MOA, Medical device, Generic drug, Pharmaceutical industry, Biogen, Adverum Biotechnologies, Bevacizumab, Genentech

EXTON, Pa., Sept. 1, 2022 /PRNewswire/ -- Since the FDA approval in January this year, ophthalmologists have been very optimistic about their intended use of Genentech's Vabysmo (faricimab-svoa) for the treatment of neovascular (wet) age-related macular degeneration (nAMD). The latest quarterly report included in Spherix's RealTime Dynamix™ service offered in nAMD captured feedback from 110 US ophthalmologists on the full inline and pipeline picture of the evolving treatment landscape.

Key Points: 
  • To no surprise, Regeneron's blockbuster anti-VEGF, Eylea, still reigns supreme in terms of brand share (among other metrics), with Genentech's Avastin (bevacizumab, off-label) falling shortly behind.
  • An 8mg Eylea option (being investigated at both a 12-week and 16-week dosing schedule) is highly anticipated by ophthalmologists.
  • Indeed, over two-thirds of respondents agreed that an on-label 16-week dosing option would be a real "game changer" in the market.
  • However, while 8mg Eylea would serve as a worthy competitor against Vabysmo, ophthalmologists indicate it is more likely to reel in patients from Eylea 2mg.

Adverum Biotechnologies Reports Second Quarter 2022 Financial Results

Retrieved on: 
Thursday, August 11, 2022
FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, U.S. Securities and Exchange Commission, Cell, IVT, Injection, GLOBE, Neovascularization, Standard of care, Technology, European Medicines Agency, Annual general meeting, Private Securities Litigation Reform Act, SEC, Investment, Incidence, IND, Prevalence, Research, Caregiver, Society, Home After Three Months Away, Compliance, LUNA, Patient, Gene, ASRS, Program, Eye, Severe cognitive impairment, Therapy, AMD, OPTIC, NASDAQ, VEGF, Lance, Macular degeneration, Macula of retina, Intravitreal injection, Nasdaq, Retina, American Society of Gene and Cell Therapy, NAMD, Food, EMA, Consultant, Investigational New Drug, Pharmaceutical industry, Vaccine, Online gambling, Adverum Biotechnologies

REDWOOD CITY, Calif., Aug. 11, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced financial results for the second quarter ended June 30, 2022.

Key Points: 
  • - Dosing first Phase 2 LUNA trial participant with ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) on track for the third quarter of 2022 and preliminary data anticipated throughout 2023
    REDWOOD CITY, Calif., Aug. 11, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced financial results for the second quarter ended June 30, 2022.
  • In April 2022, the U.S. Food and Drug Administration (FDA) provided Adverum with Type C Meeting feedback.
  • Stock-based compensation expense included in research and development expenses was $1.8million for the second quarter of 2022.
  • Stock-based compensation expense included in general and administrative expenses was $3.1 million for the second quarter of 2022.

DGAP-News: U.S. Food and Drug Administration (FDA) approved FYB201/CIMERLITM1 (ranibizumab-eqrn), the first and only biosimilar interchangeable with Lucentis®2

Retrieved on: 
Wednesday, August 3, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Ophthalmology, NAMD, Diabetes, United, III, Multiple sclerosis, DME, Diabetic retinopathy, Blood, Retina, DR, Food, ISIN, Central retinal vein occlusion, Rheumatoid arthritis, Biosimilar, CEO, Union, RVO, Ranibizumab, EMA, Macular edema, Immortalised cell line, Eye, COLUMBUS, Marketing, Conditional sentence, Patent, Safety, COVID-19, Cancer, Retinal, MedImmune, Inc. v. Genentech, Inc., Review, VEGF, FDA, Patient, Pharmacokinetics, Macular degeneration, Retinal haemorrhage, Nasopharyngeal carcinoma, Generic drug, Pharmaceutical industry, Fine chemical, EU

[i]

Key Points: 
  • [i]
    FDA-approval and interchangeability designation are based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data.
  • Efficacy, safety, pharmacokinetics and immunogenicity of CIMERLI were found to be comparable to the reference drug Lucentis in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD).
  • It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.
  • Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines.

Adverum Biotechnologies Announces Upcoming Data Presentation at ASRS 2022

Retrieved on: 
Friday, July 8, 2022
OPTIC, Patient, Publication, Macular degeneration, Research, NAMD, Annual general meeting, Severe cognitive impairment, ASRS, GLOBE, Retina, U.S. Securities and Exchange Commission, Prevalence, Compliance, Private Securities Litigation Reform Act, Neovascularization, Technology, Standard of care, Nasdaq, SEC, Incidence, AMD, NASDAQ, Safety, Society, Program, IVT, Pharmaceutical industry, Adverum Biotechnologies

REDWOOD CITY, Calif., July 08, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that new data from the Phase 1 OPTIC study of ADVM-022 (AAV.7m8-aflibercept) development program in wet age-related macular degeneration (wet AMD) will be presented next week during the American Society of Retina Specialists (ASRS) 2022 Annual Meeting in New York City. The presentation will include new best-corrected visual acuity (BCVA) results, as well as the previously reported aflibercept protein expression data through three years post-treatment with ADVM-022 (ixoberogene soroparvovec).

Key Points: 
  • The presentation will include new best-corrected visual acuity (BCVA) results, as well as the previously reported aflibercept protein expression data through three years post-treatment with ADVM-022 (ixoberogene soroparvovec).
  • Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD, affecting approximately 10% of patients living with AMD.
  • AMD is projected to impact 288 million people worldwide by 2040, with wet AMD accounting for approximately 10% of those cases.
  • Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Adverum Biotechnologies Completes IND Amendment and Prepares to Initiate the Phase 2 LUNA Trial of ADVM-022 in Wet AMD

Retrieved on: 
Wednesday, July 6, 2022
VEGF, Review, FDA, OPTIC, Injection, Patient, European Medicines Agency, University of Nevada, Reno School of Medicine, Macular degeneration, Research, NAMD, University of Nevada, Reno, Severe cognitive impairment, M.A, GLOBE, AAV, Difluprednate, Retina, Union, U.S. Securities and Exchange Commission, Inflammation, Compliance, Prevalence, World, Â, Food, State, Neovascularization, IND, Private Securities Litigation Reform Act, Heel, Technology, University, Standard of care, Nasdaq, SEC, Incidence, AMD, NASDAQ, Safety, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, LUNA, IVT, Pharmaceutical industry, Adverum Biotechnologies

REDWOOD CITY, Calif., July 06, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that it has completed its Investigational New Drug (IND) amendment with the U.S. Food and Drug Administration (FDA) and is preparing to initiate the Phase 2 LUNA trial of ADVM-022, a single intravitreal (IVT) injection for wet age-related macular degeneration (wet AMD). The World Health Organization’s Review Council and the U.S. Adopted Names Council has adopted the name ixoberogene soroparvovec (Ixo-vec) for ADVM-022 as the international nonproprietary name.

Key Points: 
  • We amended our IND and are on track to dose the first patient in the Phase 2 LUNA trial for the treatment of wet AMD in the coming months.
  • We are excited to initiate our Phase 2 LUNA trial this quarter.
  • The LUNA trial is a multicenter, double-masked, randomized, parallel-group Phase 2 trial evaluating two doses of Ixo-vec, including the 2x10^11 vg/eye dose and a new, lower 6x10^10 vg/eye dose, in wet AMD.
  • Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD, affecting approximately 10% of patients living with AMD.

EyePoint Pharmaceuticals to Present 12-Month Results from Phase 1 DAVIO Clinical Trial Evaluating EYP-1901 for the Treatment of Wet AMD at the American Society of Retina Specialists 2022 Annual Meeting

Retrieved on: 
Friday, June 10, 2022
ACT, Eye, Time, Retinal, Șaeș, Company, Society, THE, ASRS, Annual report, Forward-looking statement, News, AMD, Annual general meeting, Toxic leukoencephalopathy, Nasdaq, Therapy, NAMD, FDA, Patient, GLOBE, Private Securities Litigation Reform Act, U.S. FDA, COVID-19, NASDAQ, SEC, Visual acuity, Diabetic retinopathy, Pharmaceutical industry

ET

Key Points: 
  • ET
    The Phase 1 DAVIO trial is an open-label, dose escalation clinical trial of EYP-1901 that enrolled 17 patients with previously treated wet AMD.
  • Phase 2 clinical trials are planned for wet AMD in Q3 2022 and in diabetic retinopathy in 2H 2022.
  • Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.
  • EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Adverum Biotechnologies Announces New Data at the Macula Society’s 2022 Annual Meeting

Retrieved on: 
Thursday, June 2, 2022
Compliance, Retina, Severe cognitive impairment, Lance, Program, Macular degeneration, Neovascularization, Eye, Macula of retina, AMD, VEGF, Annual general meeting, Nasdaq, OPTIC, NAMD, GLOBE, Patient, Private Securities Litigation Reform Act, Publication, Technology, Weill Cornell Medicine, Research, Incidence, SEC, Prevalence, IVT, Dean (education), Degenerative disease, U.S. Securities and Exchange Commission, Safety, Vaccine, Pharmaceutical industry, Ophthalmology, Adverum Biotechnologies

REDWOOD CITY, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced new data from the Phase 1 OPTIC study ADVM-022 (AAV.7m8-aflibercept) development program in wet age-related macular degeneration (wet AMD) will be presented during the Macula Society’s 2022 Annual Meeting in Berlin, Germany. The presentation will include an update on aflibercept protein expression data through three years post-treatment. In addition, a new analysis will compare the anatomical outcomes of a single intravitreal injection of ADVM-022 to standard-of-care bolus anti-vascular endothelial growth factor (VEGF) therapy in patients with wet AMD and will include an evaluation of the impact of baseline levels of neutralizing antibodies (NAbs) to AAV.7m8 on ADVM-022 efficacy, safety, and anatomical measures.

Key Points: 
  • The presentation will include an update on aflibercept protein expression data through three years post-treatment.
  • Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.
  • Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.