Retinal haemorrhage

Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorised

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Dienstag, Januar 2, 2024
Medical Subject Headings, Floater, Cataract, Marketing, Protein, BRVO, INN, Neovascularization, Complication, ATC, DME, Endophthalmitis, Retinal detachment, Blood, Bleeding, International, Ranibizumab, AMD, Injection, Disease, Diabetes, Language, CRVO, Eye, Pressure, Swelling, Inflammation, Intraocular pressure, RVO, European Medicines Agency, Infection, Cerebral edema, CNV, Growth, Select, Macular edema, Patient, Safety, Anatomy, Paratriathlon, Retina, IIA, Retinal haemorrhage, Three-body problem, Medical device

Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorised

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

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Mittwoch, 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

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Mittwoch, 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.

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

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Mittwoch, Mai 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.

Oxurion Provides Update on Clinical Pipeline Progress

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Freitag, Januar 7, 2022
M.A, Safety, Plasma kallikrein, CFA, Intravitreal injection, Month, RVO, Patient, Physician, Clinical research, Euronext, IRB, Central retinal vein occlusion, Retinal haemorrhage, INTEGRAL, Inflammation, Human, Standard of care, Injection, Angiogenesis, Probability, Macular edema, DME, Pharmaceutical industry, Part

The INTEGRAL trial is a two-part Phase 2, randomized, multi-center clinical trial and is the first trial in which multiple intravitreal injections of THR-687 will be administered in humans.

Key Points: 
  • The INTEGRAL trial is a two-part Phase 2, randomized, multi-center clinical trial and is the first trial in which multiple intravitreal injections of THR-687 will be administered in humans.
  • We are pleased to announce the completion of patient enrollment for Part A of the Phase 2 INTEGRAL trial of THR-687, Tom Graney, CFA, Chief Executive Officer of Oxurion commented.
  • This milestone brings us closer to delivering a potential first line treatment of choice for patients with DME.
  • Arshad M. Khanani, M.D., M.A., Director of Clinical Research at Sierra Eye Associates, Reno, Nevada, US will present the Part A data on February 12th.

2021 Insights on Retinal Vein Occlusion (Ophthalmology) Drugs in Development - ResearchAndMarkets.com

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Freitag, Dezember 10, 2021
Biotechnology, Pharmaceutical, Health, ROA, Ophthalmology, R, Central retinal vein occlusion, Therapy, Mall of America, Retinal haemorrhage, Surveying, Medical imaging, Oil, Marketing

The pipeline guide reviews pipeline therapeutics for Retinal Vein Occlusion (Ophthalmology) by companies and universities/research institutes based on information derived from company and industry-specific sources.

Key Points: 
  • The pipeline guide reviews pipeline therapeutics for Retinal Vein Occlusion (Ophthalmology) by companies and universities/research institutes based on information derived from company and industry-specific sources.
  • The pipeline guide reviews key companies involved in Retinal Vein Occlusion (Ophthalmology) therapeutics and enlists all their major and minor projects.
  • The pipeline guide evaluates Retinal Vein Occlusion (Ophthalmology) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type.
  • Formulate corrective measures for pipeline projects by understanding Retinal Vein Occlusion (Ophthalmology) pipeline depth and focus of Indication therapeutics.

OXURION NV Secures EUR 10 Million Convertible Bond Financing from Kreos Capital and Pontifax Ventures

Retrieved on: 
Montag, November 22, 2021
Patient, CEO, Central retinal vein occlusion, Plasma kallikrein, BE, Diabetic retinopathy, Company, Debt, Hand, GlobalData, RVO, DME, Therapy, Euronext, AMD, CFA, EUR, CFO, KREO, VWAP, Macular edema, Partner, Retinal haemorrhage, Creative industries, Pharmaceutical industry, Bank

THR-687 is a highly selective pan-RGD integrin antagonist that is initially being developed as a potential first line therapy for DME patients.

Key Points: 
  • THR-687 is a highly selective pan-RGD integrin antagonist that is initially being developed as a potential first line therapy for DME patients.
  • Pontifax is pleased to support Oxurion with growth capital and to be a part of its exciting future.
  • The secured debt facility with Kreos Capital and Pontifax Ventures is for a total of EUR 10 million in the form of convertible bonds, subject to customary closing conditions.
  • The loan agreement provides for a EUR 125,000 transaction fee and EUR 350,000 end of loan fee.

Aerie Pharmaceuticals Announces Presentation at the 39th Annual Scientific Meeting of the American Society of Retina Specialists

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Mittwoch, Oktober 6, 2021
Pharmaceutical, Optical, Health, Clinical Trials, Central retinal vein occlusion, Food, Dexamethasone, Retinal haemorrhage, Duane syndrome, Regulation of tobacco by the U.S. Food and Drug Administration, Central Time, Glaucoma, RVO, University, NASDAQ, Retina, FDA, Patient, Medication, PGA, Latanoprost, Diabetic retinopathy, Aerie Pharmaceuticals, Ocular hypertension, Conjunctivitis, Netarsudil, Aerie, IOP, Society, Pharmaceutical industry

Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), an ophthalmic pharmaceutical company, today announced that topline results from the AR-1105 (dexamethasone intravitreal implant) Phase 2 clinical trial in patients with macular edema due to retinal vein occlusion will be presented at the 39th Annual Scientific Meeting of the American Society of Retina Specialists in San Antonio, Texas.

Key Points: 
  • Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), an ophthalmic pharmaceutical company, today announced that topline results from the AR-1105 (dexamethasone intravitreal implant) Phase 2 clinical trial in patients with macular edema due to retinal vein occlusion will be presented at the 39th Annual Scientific Meeting of the American Society of Retina Specialists in San Antonio, Texas.
  • Singer, M.D., Clinical Professor of Ophthalmology at the University of Texas Health Science Center.
  • In clinical trials of Rhopressa, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage.
  • In clinical trials of Rocklatan, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage.

REGENXBIO Announces Additional Positive Long-term and Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD

Retrieved on: 
Mittwoch, April 22, 2020
Ophthalmology, Organ systems, Vision, RTT, Macular degeneration, Senescence, Retinopathy, Diabetic retinopathy, Retinal haemorrhage, Retina

ET featuring wet AMD Key Opinion Leaders, Allen C. Ho, M.D., Robert Avery, M.D., and Peter Campochiaro, M.D.

Key Points: 
  • ET featuring wet AMD Key Opinion Leaders, Allen C. Ho, M.D., Robert Avery, M.D., and Peter Campochiaro, M.D.
  • We are also continuing our preparations to initiate a Phase II trial for the in-office suprachoroidal delivery of RGX-314 in wet AMD patients in the first half of this year."
  • Retinal hemorrhage was observed in 17% of patients and is an anticipated event in patients with severe wet AMD.
  • RGX-314 is being developed as a potential one-time treatment for wet AMD, diabetic retinopathy, and other additional chronic retinal conditions treated with anti-VEGF.