Aflibercept

EYLEA® HD (aflibercept) Injection 8 mg Pivotal Data in Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME) Published in The Lancet

Retrieved on: 
Friday, March 8, 2024
FACS, Regeneron Pharmaceuticals, Research, HD, Food, Floater, Cataract, Consultant, Aflibercept, Diabetic retinopathy, European, Intraocular pressure, Safety, DR, Society, Retinal, Bayer, Diabetes, Patient, Publication, Pharmaceutical industry

TARRYTOWN, N.Y., March 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced The Lancet published one-year results from the pivotal PULSAR and PHOTON trials for EYLEA® HD (aflibercept) Injection 8 mg. Specifically, the publications detailed data demonstrating that EYLEA HD extended dosing regimens were non-inferior to EYLEA® (aflibercept) Injection 2 mg for both the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).

Key Points: 
  • Specifically, the publications detailed data demonstrating that EYLEA HD extended dosing regimens were non-inferior to EYLEA® (aflibercept) Injection 2 mg for both the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).
  • “Less than a year after its approval, EYLEA HD has already made an impact in the treatment of wet age-related macular degeneration and diabetic macular edema.
  • EYLEA HD has provided disease control for my tough-to-treat cases of diabetic eye disease and allowed both my diabetic and wet age-related macular degeneration patients to enjoy less frequent dosing with a similar safety profile to EYLEA.”
    PULSAR and PHOTON are two double-masked, active-controlled pivotal trials evaluating EYLEA HD compared to EYLEA.
  • In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD.

Stakes Are High for Regeneron's Eylea HD as Genentech's Vabysmo Continues to Gain Momentum, Prompting Doctors to Weigh Their Options Between Two Industry Titans, According to Spherix Global Insights

Retrieved on: 
Thursday, February 8, 2024
Ranibizumab, Ophthalmology, RealTime, Medicare, Regeneron Pharmaceuticals, Physician, AMD, Wet, Genentech, HCP, Macular degeneration, Marketing, Patient, Aflibercept, Pharmaceutical industry

Wet AMD poses a particularly severe threat to vision, necessitating treatment with biologic therapies administered in four to twelve-week intervals.

Key Points: 
  • Wet AMD poses a particularly severe threat to vision, necessitating treatment with biologic therapies administered in four to twelve-week intervals.
  • However, the current treatment landscape often burdens elderly patients with high treatment frequencies, impacting their ability to attend all appointments.
  • Spherix Global Insights conducted an in-depth analysis through its RealTime Dynamix™ report series, delving into the evolving perceptions of ophthalmologists (n=101) regarding approved therapies for wet AMD.
  • In January 2024, ophthalmologists were surveyed on their preferred biologic treatment for wet AMD among other topics.

4DMT Presents Positive Interim Data from Randomized Phase 2 PRISM Clinical Trial of Intravitreal 4D-150 Demonstrating Favorable Tolerability & Clinical Activity in Wet AMD

Retrieved on: 
Saturday, February 3, 2024
Injection, Paratriathlon, Conference, Inflammation, Aflibercept, Data, Clinical trial, AMD, Patient, Conditional sentence, OCT, PRISM, FDA, EMA, Retina, Visual acuity, Arm, DME, Angiogenesis, M.A, Webcast, CST, Pharmaceutical industry

Data presented at the Angiogenesis, Exudation, and Degeneration 2024 Conference by Arshad M. Khanani, M.D., M.A., FASRS, consisted of 24-week landmark results from the randomized Phase 2 Dose Expansion cohort of the PRISM clinical trial.

Key Points: 
  • Data presented at the Angiogenesis, Exudation, and Degeneration 2024 Conference by Arshad M. Khanani, M.D., M.A., FASRS, consisted of 24-week landmark results from the randomized Phase 2 Dose Expansion cohort of the PRISM clinical trial.
  • "I am encouraged by the potential of a one-time intravitreal injection of 4D-150 for treating wet AMD.
  • Results from the Phase 1 and interim results from Phase 2 cohorts of the PRISM study confirm that 4D-150 is well tolerated and maintains stable visual acuity in previously treated high-need patients.
  • I believe 4D-150 has the potential to revolutionize the treatment approach for our patients with wet AMD, and I am looking forward to participating in the Phase 3 trials."

EQS-News: Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea® (Aflibercept)

Retrieved on: 
Saturday, December 30, 2023
NAMD, Marketing, EMA, MAA, Retina, Blood, VEGF, Ageing, European Medicines Agency, Aflibercept, Ophthalmology, Vaccine

Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea® (Aflibercept)

Key Points: 
  • Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea® (Aflibercept)
    The issuer is solely responsible for the content of this announcement.
  • Press Release // November 27, 2023
    Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea® (Aflibercept)
    Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (Klinge) announce that the marketing authorization application (MAA) for FYB203, a biosimilar candidate for Eylea®1 (Active ingredient: Aflibercept) has been submitted to the European Medicines Agency (EMA).
  • Eylea® is used in the treatment of neovascular age-related macular degeneration (nAMD) and other severe retinal diseases.
  • "Our latest MAA submission once again demonstrates the high performance and reliability of the entire #TeamFormycon.

EQS-News: Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea® (Aflibercept)

Retrieved on: 
Wednesday, December 27, 2023
European Medicines Agency, VEGF, EMA, Retina, Ranibizumab, AMD, Marketing, Aflibercept, MAA, Patient

Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea® (Aflibercept)

Key Points: 
  • Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea® (Aflibercept)
    The issuer is solely responsible for the content of this announcement.
  • Press Release // December 27, 2023
    Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea®(Aflibercept)
    Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge”) announce that the European Medicines Agency (“EMA”) has accepted the marketing authorization application (“MAA”) for FYB203, a biosimilar candidate to Eylea®1 (Active Ingredient: Aflibercept), for review.
  • Aflibercept is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases.
  • "The experience of recent years shows that both patients and healthcare systems benefit from biosimilar competition.

China Aflibercept Market Investigation Report 2022-2031 - ResearchAndMarkets.com

Retrieved on: 
Monday, August 8, 2022
Pharmaceutical, Health, Optical, CDE, Visual impairment, Retinopathy, DRUG, Regeneron Pharmaceuticals, DME, Hospital, Patient, Marketing, COVID-19, NMPA, CAGR, SCB-2019, Renewable energy, Pharmaceutical industry, Animal, Fine chemical, Aflibercept, Bayer

The "Investigation Report on China's Aflibercept Market 2022-2031" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Investigation Report on China's Aflibercept Market 2022-2031" report has been added to ResearchAndMarkets.com's offering.
  • By July 2022, Bayer AG is the only manufacturer in the Chinese Aflibercept market.
  • According to this market research, after Aflibercept entered the Chinese market, the sales value of Aflibercept in China increased from CNY8.3 million in 2018 to CNY238 million in 2021.
  • 2 Sales of Aflibercept in China, 2018-2021
    2.3 Sales of Aflibercept by Dosage Form in China, 2018-2021
    3 Analysis of Major Aflibercept Manufacturers in China, 2018-2021
    4 Prices of Aflibercept for Different Manufacturers in China, 2021-2022
    5 Prospect of Chinese Aflibercept drug Market, 2022-2031
    View source version on businesswire.com: https://www.businesswire.com/news/home/20220808005358/en/

Regeneron Pharmaceuticals (REGN) Long-Term Investor Alert: Contact Johnson Fistel Regarding Investigation

Retrieved on: 
Friday, July 30, 2021
Regeneron Pharmaceuticals, Life sciences, Sanofi, Breakthrough therapy, Aflibercept, Monoclonal antibodies, Drugs, Health care

SAN DIEGO, July 30, 2021 (GLOBE NEWSWIRE) -- Johnson Fistel, LLP is investigating potential claims on behalf of Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) against certain of its current and former officers and directors.

Key Points: 
  • SAN DIEGO, July 30, 2021 (GLOBE NEWSWIRE) -- Johnson Fistel, LLP is investigating potential claims on behalf of Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) against certain of its current and former officers and directors.
  • Regeneron allegedly paid these substantial sums only after confirming that the foundation needed the money to cover co-pays only for Eylea and not for competing drugs.
  • If you are a current, long-term shareholder of Regeneron, holding shares since 2013, and are interested in learning more about the investigation, please contact Jim Baker ( [email protected] )by email or phone 619-814-4471.
  • Johnson Fistel, LLP is a nationally recognized shareholder rights law firm with offices in California, New York and Georgia.

Graybug Vision Reports Full-Data Analysis from 12-Month Treatment Phase of ALTISSIMO Phase 2b Trial in Wet AMD

Retrieved on: 
Wednesday, May 12, 2021
Aflibercept, Breakthrough therapy, Sanofi, Drugs, Clinical medicine, Health sciences

As previously reported, the development of GB-102 2mg was terminated in 2020 following an interim safety analysis.

Key Points: 
  • As previously reported, the development of GB-102 2mg was terminated in 2020 following an interim safety analysis.
  • The trial was not powered to assess non-inferiority to aflibercept.\nOverall, GB-102 1mg was safe and well-tolerated.
  • ET / 5 a.m. PT today, May 12, 2021, to discuss the ALTISSIMO clinical results.
  • Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Redwood City, California.

China Aflibercept Market Report 2021: An Anti-VEGF Drug - Relevant Concepts, Sales 2018-2020, Major Manufacturers 2018-2020, Prices 2020-2021, & Prospects 2021-2025 - ResearchAndMarkets.com

Retrieved on: 
Monday, May 10, 2021
Health, Pharmaceutical, Branches of biology, Life sciences, Countries, Breakthrough therapy, Angiogenesis inhibitors, Aflibercept, Sanofi, Regeneron Pharmaceuticals, Bayer, Vascular endothelial growth factor, Macular degeneration, Economy of China

b'The "Investigation Report on China\'s Aflibercept Market 2021-2025" report has been added to ResearchAndMarkets.com\'s offering.\nAflibercept is an anti-VEGF drug, mainly used to treat neovascular age-related macular degeneration (wAMD), and other retinopathy caused by visual impairment.

Key Points: 
  • b'The "Investigation Report on China\'s Aflibercept Market 2021-2025" report has been added to ResearchAndMarkets.com\'s offering.\nAflibercept is an anti-VEGF drug, mainly used to treat neovascular age-related macular degeneration (wAMD), and other retinopathy caused by visual impairment.
  • Regeneron has exclusive sales rights in the U.S. market, while Bayer obtains exclusive sales rights outside the U.S. Their Aflibercept, EYLEA was launched in China in 2018.
  • By 2020, Bayer AG is the only manufacturer in the Chinese Aflibercept market.\nAccording to this market research, after Aflibercept entered the Chinese market, the sales value of Aflibercept in China increased from CNY8.3 million in 2018 to CNY 110 million in 2020.
  • Besides, Aflibercept was included in the national medical insurance catalog at the beginning of 2020, so the price has been lowered, which reduces the burden on patients and will stimulate sales in the future.\n2 Sales of Aflibercept in China, 2018-2020\n2.3 Sales of Aflibercept by Dosage Form in China, 2018-2020\n3 Analysis of Major Aflibercept Manufacturers in China, 2018-2020\n4 Prices of Aflibercept for Different Manufacturers in China, 2020-2021\n5 Prospect of Chinese Aflibercept drug Market, 2021-2025\n'

Ashvattha Therapeutics Presents Transformative Anti-Angiogenesis Treatment for Retinal Disorders at ARVO 2021

Retrieved on: 
Monday, April 26, 2021
Biotechnology, Pharmaceutical, Health, Clinical trials, Clinical medicine, Ophthalmology, Medicine, Angiogenesis inhibitors, Breakthrough therapy, Choroidal neovascularization, Intravitreal administration, Macular degeneration, Aflibercept, Intravitreal injection, CNV

Current treatments for wet AMD, a degenerative disease, require invasive, intravitreal injections into the eye, as often as once every 4 weeks.

Key Points: 
  • Current treatments for wet AMD, a degenerative disease, require invasive, intravitreal injections into the eye, as often as once every 4 weeks.
  • Our results show that a single subcutaneous or oral dose of D-4517 safely suppresses choroidal neovascularization, a major cause of vision loss, comparable to intravitreal aflibercept.
  • HDs are retained in these cells in CNV lesion for at least 1 month after a single systemic dose.
  • Ashvattha has initiated multiple programs with HDTs focused on neuro-oncology, neurology, age-related macular degeneration (AMD), and hyperinflammation in diseases such as COVID-19.