Central retinal vein occlusion

Age-related Macular Degeneration Global Market Report 2022: Surging Prevalence of Retinal Disorders Bolsters Growth - ResearchAndMarkets.com

Retrieved on: 
Monday, January 16, 2023
Pharmaceutical, Health, Optical, Disease, Administration, Statistics, Intravitreal injection, Government, FDA, AMD, Projection, U.S. FDA, Growth, Region, Patient, Prevalence, Brolucizumab, American Academy of Ophthalmology, Macular degeneration, American Academy, Pharmacy, Biogen, Central retinal vein occlusion, Inflammation, Incidence, USD, Market share, Investment, Pharmaceutical industry, Generic drug, Ranibizumab, Ophthalmology, EU

Increasing R&D investments, expanding geriatric population, surging number of people with retinal disorders, product launch and approval, and medicines for the treatment of dry AMD are factors contributing to the market growth.

Key Points: 
  • Increasing R&D investments, expanding geriatric population, surging number of people with retinal disorders, product launch and approval, and medicines for the treatment of dry AMD are factors contributing to the market growth.
  • Surging number of people with retinal disorders is expected to stimulate the market growth.
  • According to statistics, the market expansion is significantly associated with the rising number of people suffering from retinal problems.
  • Thus, the growing prevalence of these conditions is fuelling demand for macular degeneration treatments, which is further boosting market growth.

Coherus to Launch CIMERLI™ (ranibizumab-eqrn) in the United States on October 3, 2022

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Monday, September 19, 2022
Retinal, ATE, Safety, Diabetic retinopathy, Â, Infection, Patient, Endophthalmitis, Thrombosis, D-2, Ateş, Myocardial infarction, Death, Adoption, Food, Macular edema, Neovascularization, VEGF, DR, Excipient, Central retinal vein occlusion, Venous thrombosis, FACS, Fatal, Risk, FDA, Protein, Degenerative disease, CEO, Odds ratio, GLOBE, Intraocular pressure, RVO, Fatality, Vance DeGeneres, Clinical research, IOP, Hypersensitivity, Intravitreal injection, DME, Stroke, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, AMD, BLA, Generic drug, Pharmaceutical industry, Vaccine, Ranibizumab

REDWOOD CITY, Calif., Sept. 19, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) today announced the commercial availability, beginning October 3, 2022, of CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all approved indications. CIMERLI is an anti-VEGF therapy within a class of biologics that has been revolutionary in helping retinal patients maintain or gain vision. CIMERLI was approved by the U.S. Food and Drug Administration (FDA) in August 2022, having met FDA’s standards of biosimilarity and interchangeability to the reference product, including safety, efficacy and quality.1

Key Points: 
  • CIMERLI is an anti-VEGF therapy within a class of biologics that has been revolutionary in helping retinal patients maintain or gain vision.
  • As a company, we embrace high performance in everything we do, while valuing our patient-centric approach to our mission.
  • CIMERLI is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in Lucentis and CIMERLI.
  • Coherus licensed CIMERLI from Bioeq AG, a joint venture between Polpharma Biologics Group B.V. and Formycon AG.

European Commission grants marketing authorization for Ranivisio▼®* (ranibizumab), a biosimilar to Lucentis®**, for age-related macular degeneration (AMD) the most common cause of blindness in developed countries

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Monday, August 29, 2022
Health, Other Health, General Health, Pharmaceutical, Optical, Biotechnology, RVO, COVID-19, Systematic review, ISBN, Ophthalmology, EC, Meta-analysis, Safety, Biosimilar, Patient, Visual impairment, Travel, Conditional sentence, Blood, MedImmune, Inc. v. Genentech, Inc., Chapter Seven, Severe cognitive impairment, Incidence, VEGF, British Journal of Ophthalmology, Srinivas, Teva Pharmaceuticals, Vance DeGeneres, Teva, PDR, Central retinal vein occlusion, Investment, CNV, AMD, TASE, European Commission, Private Securities Litigation Reform Act, Growth, Marketing, Academic Press, NYSE, JAMA Ophthalmology, Retina, DME, Royal commission, Union, Compliance, Failure, III, TEVA, Industry, Corneal neovascularization, Annual report, European Commercial Internet Exchange, Forward-looking statement, Generic drug, Pharmaceutical industry, Fine chemical, Medical device, EU, Ranibizumab

It is a leading cause of blindness for working age adults with uncontrolled diabetes3, and the most common cause of blindness in developed countries2.

Key Points: 
  • It is a leading cause of blindness for working age adults with uncontrolled diabetes3, and the most common cause of blindness in developed countries2.
  • It is estimated that up to 77 million Europeans will be affected with AMD by 20504.
  • AMD is caused by excessive growth of blood vessels in the retina that leads to visual impairment and can even cause blindness.
  • Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of these blood vessels in the retina5.

UNITY Biotechnology, Inc. Reports Second Quarter 2022 Financial Results and Business Updates

Retrieved on: 
Friday, August 12, 2022
U.S. Securities and Exchange Commission, Risk, CST, Vasculitis, Injection, P-value, Inflammation, GLOBE, Population, UNITY, DME, Research, Eye, Unity Biotechnology, Company, Twitter, SAN, Biotechnology, TEK tyrosine kinase, Therapy, Endophthalmitis, Ageing, AMD, Safety, Central retinal vein occlusion, NASDAQ, Intention, Lists of diseases, VEGF, Operating cost, Cellular senescence, UBX, LinkedIn, Blood, Retina, Pharmaceutical industry, Dentistry, Patient

SOUTH SAN FRANCISCO, Calif., Aug. 12, 2022 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (UNITY) [NASDAQ:UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today reported financial results for the second quarter ended June 30, 2022.“We are thrilled with the recent data announced in our BEHOLD Study in patients with DME and are grateful for the support and enthusiasm from our physician community and other stakeholders,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “The sustained and significant improvement in visual acuity after a single injection of UBX1325 is very impressive, and , if approved, could provide an attractive treatment option for patients who currently can only hope to maintain their vision at the cost of frequent injections with current standard of care. We look forward to sharing our 24-week data in BEHOLD as we continue to investigate UBX1325, along with 16-week data in ENVISION, our study in wet age-related macular degeneration.”

Key Points: 
  • Based on pre-defined proof-of-concept criteria of alpha=0.15, the study demonstrated a statistically significant treatment effect for both BCVA and CST at both timepoints.
  • UNITY believes that current cash, cash equivalents, and marketable securities are sufficient to fund operations through the first quarter of 2023.
  • Cash used in operations during the first and second quarters of 2022 was $29.8 million compared to $28.5 million for the first and second quarters of 2021.
  • Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.

UNITY Biotechnology Announces Positive Data in Phase 2 BEHOLD Study of UBX1325 in Patients with Diabetic Macular Edema

Retrieved on: 
Friday, August 12, 2022
Apoptosis, M.A, Compte rendu, Â, Diabetic retinopathy, Survival, U.S. Securities and Exchange Commission, Risk, CST, Vasculitis, Inflammation, Injection, Bcl-xL, Trial of the century, GLOBE, Population, UNITY, Visual acuity, DME, Security (finance), Unity Biotechnology, Patient, Cell, COVID-19, Letter, Twitter, SAN, Biotechnology, Severe cognitive impairment, Eye, Therapy, Endophthalmitis, Ageing, AMD, Safety, Central retinal vein occlusion, Lists of diseases, Intention, Conference call, Webcast, Protein, Ophthalmology, University, Nasdaq, Cellular senescence, LinkedIn, UBX, Conference, Clinical research, Pharmaceutical industry, Dentistry

SOUTH SAN FRANCISCO, Calif., Aug. 12, 2022 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [Nasdaq: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced 12- and 18-week data from its Phase 2 BEHOLD study of UBX1325, a senolytic Bcl-xL inhibitor, in patients with diabetic macular edema (DME).

Key Points: 
  • ET
    SOUTH SAN FRANCISCO, Calif., Aug. 12, 2022 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (UNITY) [Nasdaq: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced 12- and 18-week data from its Phase 2 BEHOLD study of UBX1325, a senolytic Bcl-xL inhibitor, in patients with diabetic macular edema (DME).
  • In addition, patients treated with UBX1325 maintained CST compared to sham-treated patients who demonstrated progressive worsening of CST (i.e., increased retinal thickness) through 18 weeks.
  • These data represent an important and exciting step in validating the senolytic therapeutic concept that is core to UNITYs platform.
  • The results are particularly noteworthy considering that there is a progressive improvement in vision through 18 weeks after a single injection of UBX1325.

Brand Institute Partners on Brand Name Development for FDA Approved Treatment to Help Retinal Disease Patients Maintain or Gain Vision

Retrieved on: 
Monday, August 8, 2022
FDA, Central retinal vein occlusion, World Health Organization, C.E.O, American Medical Association, Macular edema, Name, Food and Drug Administration, European Medicines Agency, Approximation error, Brand Institute, Patient, Review, Biosimilar, Therapy, Safety, Health Canada, Diabetic retinopathy, WHO, World, AMA, HC, Food, EMA, Pharmaceutical industry

Ranibizumab-eqrn, a vascular endothelial growth factor inhibitor, is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy and Myopic Choroidal Neovascularization.

Key Points: 
  • Ranibizumab-eqrn, a vascular endothelial growth factor inhibitor, is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy and Myopic Choroidal Neovascularization.
  • "The entire Brand Institute and Drug Safety Institute Team congratulates Coherus BioSciences on the FDA approval of CIMERLI," said Brand Institute's Chairman and C.E.O., James L. Dettore.
  • The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year with healthcare manufacturers.
  • These regulatory experts co-authored the name review guidelines while with their respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications.

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.

FDA Approves Coherus’ CIMERLI™ (ranibizumab-eqrn) as the First and Only Interchangeable Biosimilar to Lucentis® for All Five Indications, with 12 Months of Interchangeability Exclusivity

Retrieved on: 
Wednesday, August 3, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Thrombosis, Visual acuity, BLA, DR, Intraocular pressure, Macular edema, Retinal, Safety, News, IOP, VEGF, Death, Knowledge, Infection, Diabetic retinopathy, Retina, Odds ratio, Ateş, Intravitreal injection, Excipient, ATE, GLOBE, Food, CHRS, Central retinal vein occlusion, Endophthalmitis, Biosimilar, Fatality, CEO, RVO, Venous thrombosis, Pharmacy, Severe cognitive impairment, FDA, Myocardial infarction, Hypersensitivity, FCB, DME, Degenerative disease, Commercial, AMD, Risk, Stroke, Fatal, Retinal haemorrhage, D-2, Protein, Pharmaceutical industry, Vaccine, Generic drug, Ranibizumab, Ophthalmology

REDWOOD CITY, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) announced today that the U.S. Food and Drug Administration (FDA) has approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all five indications, meeting the FDA’s rigorous standards to the reference product, including safety, efficacy and quality.1 CIMERLI™ belongs to the anti-VEGF therapy class of biologics that has been revolutionary in helping retinal patients maintain or gain vision.

Key Points: 
  • Coherus is the only company in the $7 billionanti-VEGF ophthalmology market with a demonstrated track record of U.S. commercial biosimilar success.
  • Our upcoming launch of CIMERLI and planned launch next year of our third approved product, our Humira biosimilar, YUSIMRY, will leverage this experience and knowledge.
  • Commercial availability of CIMERLI, in both 0.3 mg and 0.5 mg dosages, is planned for early October 2022.
  • An interchangeable biosimilar product is a biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable biosimilar medications.

Biogen and Samsung Bioepis’ BYOOVIZ™ (ranibizumab-nuna) Launches in the United States

Retrieved on: 
Thursday, June 2, 2022
Biotechnology, Retinal, Hematology, Failure, Climate, IOP, COVID-19, Lists of diseases, Macular edema, Drug development, U.S. Securities and Exchange Commission, Severe cognitive impairment, Intellectual property, Macular degeneration, Food, Pathology, Partnership, AMD, VEGF, Central retinal vein occlusion, Health, Biosimilar, Intravitreal injection, Social media, Gastroenterology, Patient, United Kingdom, Neuroscience, American Academy, Neovascularization, Senior, BIIB, Physician, Intraocular pressure, Endophthalmitis, Nobel Prize, Multiple sclerosis, Spinal muscular atrophy, Private Securities Litigation Reform Act, Science, Research, LinkedIn, Health care, News, YouTube, Nasdaq, Samsung, FDA, Endocrinology, GLOBE, Risk, Twitter, Safety, Pharmaceutical industry, Generic drug, Biogen, Ophthalmology, Facebook

and INCHEON, Korea, June 02, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Samsung Bioepis Co., Ltd. today announced that BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS (ranibizumab)i has been launched in the United States.

Key Points: 
  • and INCHEON, Korea, June 02, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Samsung Bioepis Co., Ltd. today announced that BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS (ranibizumab)i has been launched in the United States.
  • The launch of BYOOVIZ in the U.S. marks an important moment for patients, healthcare providers, payers, and the entire healthcare system.
  • BYOOVIZ is the first biosimilar launch in the U.S. under the Biogen and Samsung Bioepis partnership.
  • The Biogen and Samsung Bioepis commercialization agreement includes two ophthalmology biosimilar candidates, BYOOVIZ and SB15, a biosimilar candidate referencing EYLEA (aflibercept)v. Samsung Bioepis is responsible for development, regulatory registration, and manufacture of the products, while Biogen is responsible for commercialization.

Global Diabetic Macular Edema Drug Pipeline Market Research Report 2022: Comprehensive Insights About 65+ Companies and 65+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 25, 2022
Health, Diabetes, Inflammation, PKI, BTK, PKC, RVO, II, Population, Central retinal vein occlusion, Survival, Retina, UNITY, Patient, Mergers and acquisitions, Chronic lymphocytic leukemia, Macular edema, Visual acuity, Pharmacokinetics, VEGF, Retinal haemorrhage, SAD, Adult, Intravitreal injection, Cell, Volunteering, Bcl-xL, AMD, Protein kinase C, Diabetic retinopathy, NF-κB, Human, III, IVT, CLL, Technology, Safety, ABC, Kodiak, NDA, Biotechnology, Severe cognitive impairment, Therapy, Protein, Unity Biotechnology, Diabetes, Acquisition, PK, INTEGRAL, PLCG2, DME, Pharmaceutical industry, Vaccine, Meanings of minor planet names: 16001–17000

This ''Diabetic Macular Edema - Pipeline Insight, 2022" report provides comprehensive insights about 65+ companies and 65+ pipeline drugs in Diabetic Macular Edema pipeline landscape.

Key Points: 
  • This ''Diabetic Macular Edema - Pipeline Insight, 2022" report provides comprehensive insights about 65+ companies and 65+ pipeline drugs in Diabetic Macular Edema pipeline landscape.
  • A detailed picture of the Diabetic Macular Edema pipeline landscape is provided which includes the disease overview and Diabetic Macular Edema treatment guidelines.
  • The assessment part of the report embraces, in depth Diabetic Macular Edema commercial assessment and clinical assessment of the pipeline products under development.
  • The companies and academics are working to assess challenges and seek opportunities that could influence R&D Diabetic Macular Edema.