Neovascularization

Alvotech Reports Financial Results for Full Year 2023 and Provides a Business Update

Retrieved on: 
Wednesday, March 20, 2024
Joint venture, Patient, Sale, Business analyst, CCHN, IP, Marketing, Research, Mallinckrodt, Absorption, European Economic Area, Gross metropolitan product, Webcast, Asset, Alvogen, Denosumab, Neovascularization, Biosimilar, Macular degeneration, Safety, Food, U.S. FDA, Teva Pharmaceuticals, Revenue, Q3, CES, AMD, FDA, ISK, Administration, Adalimumab, Research and development, Pharmaceutical industry

Management will conduct a business update conference all and live webcast on March 21, 2024 at 8:00 am ET (12:00 pm GMT).

Key Points: 
  • Management will conduct a business update conference all and live webcast on March 21, 2024 at 8:00 am ET (12:00 pm GMT).
  • Alvotech announced positive top-line results from a pharmacokinetic (PK) study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab).
  • Alvotech announced positive top-line results from a PK study for AVT03, a biosimilar candidate to Prolia® and Xgeva®, which both contain denosumab.
  • Alvotech will conduct a business update conference call and live webcast on Thursday, March 21, 2024, at 8:00 am ET (12:00 pm GMT).

Celularity’s Tri-layer Decellularized, Dehydrated Human Amniotic Membrane Product Investigated as a Carrier of Induced Pluripotent Stem Cell Derived-Limbal Stem Cells in the Treatment of Severe Ocular Surface Disease

Retrieved on: 
Wednesday, February 14, 2024
Engineering, Regeneration, Regenerative medicine, Inflammation, North Carolina State University, Neovascularization, Infection, South Korea, WBC, Wilson College, Tissue engineering, KSBM, Decellularization, Congress, CELU, Trauma, Tissue, Development, Culture of Korea, LSC, Wound healing

FLORHAM PARK, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”) a biotechnology company developing allogeneic cell therapies and advanced biomaterial products, today announced that its abstract “Tri-layer decellularized, dehydrated human amniotic membrane supports proliferation and stemness of limbal stem cells derived from induced pluripotent stem cells” has been accepted as a poster presentation at WBC 2024, the 12th World Biomaterials Congress which will be held on 26-31 May 2024 in Daegu, Republic of Korea, and hosted by the Korean Society for Biomaterials (KSBM). The theme of WBC 2024 is “Convergence in Biomaterials: a vision for the future of healthcare.”

Key Points: 
  • The theme of WBC 2024 is “Convergence in Biomaterials: a vision for the future of healthcare.”
    The study described in the poster presentation investigated Celularity’s tri-layer decellularized, dehydrated human amniotic membrane technology product as a carrier of induced pluripotent stem cell derived-limbal stem cells (iPSC-LSC) which were investigated for the treatment of limbal stem cell deficiency (LSCD).
  • Limbal Stem Cell (LSC) transplant is a recognized method to restore the ocular surface in advanced stem cell deficient corneas.
  • Its Tissue Engineering Lab Team is particularly interested in corneal tissue engineering, focusing primarily on ocular surface regeneration.
  • The off-the-shelf availability of existing commercial tri-layer decellularized, dehydrated human amniotic membrane products, in combination with iPSC-LSCs, may improve patient access to LSCD treatment and the therapeutic management of LSCD.

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

Retrieved on: 
Tuesday, January 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

OliX Pharmaceuticals Announces Positive Safety Data and Preliminary Efficacy Effects in a Phase 1 Trial of OLX10212 for Age-Related Macular Degeneration

Retrieved on: 
Wednesday, November 29, 2023
Seniors, Biotechnology, Pharmaceutical, Optical, Health, Genetics, Consumer, Clinical Trials, Intravitreal injection, Safety, Neovascularization, Visual acuity, RNA interference, Homeostasis, Vance DeGeneres, Patient, Small RNA, DLT, Therapy, RNA, Harvard Medical School, AMD, Macular degeneration, Sirna Therapeutics, KOSDAQ, Quality of life, Paratriathlon, Inflammation, Optimism, Pharmaceutical industry

OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, today announced positive results from a Phase 1 study evaluating the safety and tolerability of OLX10212 for the treatment of Age-Related Macular Degeneration (AMD).

Key Points: 
  • OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, today announced positive results from a Phase 1 study evaluating the safety and tolerability of OLX10212 for the treatment of Age-Related Macular Degeneration (AMD).
  • This phase 1 study is a multi-center, single-dose, dose-escalating study to evaluate the safety and tolerability of OLX10212 in patients with neovascular AMD.
  • The primary endpoints of this study were safety and tolerability assessments associated with each intravitreal OLX10212 injection.
  • The safety and tolerability evaluations, together with preliminary BCVA improvement of OLX10212 encourage further development of OLX10212 for AMD.

Innovent Presents Clinical Data of Two Ophthalmic Bispecific Antibodies IBI302 (anti-VEGF/complement) and IBI324 (anti-VEGF-A/Ang-2) at American Academy of Ophthalmology (AAO) Annual Meeting 2023

Retrieved on: 
Monday, November 6, 2023
NAMD, Neovascularization, HKEX, CFP, Trial of the century, CST, Incidence, Eye, Ophthalmology, Infrared spectroscopy correlation table, Treatment, DME, AAO, Injection, Fibrosis, MAD, SAD, Inflammation, Drug development, SAE, Retinal vasculitis, Anetoderma, Diabetic retinopathy, American Academy, American Academy of Ophthalmology, Annual general meeting, Paratriathlon, Safety, Visual acuity, Moran Eye Center, Patient, Hospital, Anti-VEGF, Pharmaceutical industry, Phosphorus, Food and Drug Administration Safety and Innovation Act

The primary endpoint was the change from baseline in best-corrected visual acuity (BCVA) in the study eye at 36 weeks.

Key Points: 
  • The primary endpoint was the change from baseline in best-corrected visual acuity (BCVA) in the study eye at 36 weeks.
  • In terms of safety, the incidence of adverse events were similar in the IBI302 2 mg group, IBI302 4 mg group, and the aflibercept 2 mg group.
  • This is a Phase 1 clinical study evaluating the safety, tolerability, and efficacy of IBI324 in the treatment of DME (ClinicalTrials.gov: NCT05489718).
  • We look forward to advancing the clinical development progress and hope Innovent's innovative medicines can benefit more patients."

FDA Approves Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)

Retrieved on: 
Friday, October 27, 2023
FDA, Health, Clinical Trials, Pharmaceutical, Optical, Biotechnology, ROG, Food, Ranibizumab, RO, AMD, DME, Injection, Warning, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Inflammation, Retinal vasculitis, RVO, Diabetic retinopathy, Colic flexures, Paratriathlon, Vascular occlusion, Roche, Eye, Macular edema, Neovascularization, Pharmaceutical industry, Vaccine, Faricimab, Genentech

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Vabysmo® (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO).

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Vabysmo® (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO).
  • RVO is the third indication for Vabysmo, in addition to wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME).
  • Together, the three retinal conditions affect around 3 million people in the U.S. and are among the leading causes of vision loss.
  • This was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluid.

Genentech’s Vabysmo Maintained Vision Improvements With Extended Treatment Intervals Up to Four Months for People With Retinal Vein Occlusion (RVO) in Phase III Trials

Retrieved on: 
Tuesday, October 10, 2023
Research, FDA, Clinical Trials, Biotechnology, Managed Care, Health, Pharmaceutical, Optical, Science, Retina, Paratriathlon, European, HIV disease progression rates, RVO, Angiogenesis, Food, Neovascularization, Inflammation, DME, United Kingdom, Roche, ROG, CRVO, BRVO, AMD, Blood, Phase, RO, Faricimab, Diabetic retinopathy, Maintenance, Macular edema, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, European Medicines Agency, Pharmaceutical industry, Medical imaging, Vaccine, Genentech

Data showed people treated with Vabysmo extended their treatment intervals up to every four months while maintaining the vision gains achieved in the first 24 weeks of the trials.

Key Points: 
  • Data showed people treated with Vabysmo extended their treatment intervals up to every four months while maintaining the vision gains achieved in the first 24 weeks of the trials.
  • Vabysmo continued to show robust and sustained drying of retinal fluid from baseline up to week 72, as measured by reduction in central subfield thickness.
  • This is the first time that vision and anatomical improvements have been maintained for more than a year using a personalized treat-and-extend dosing regimen in both global Phase III BRVO and CRVO trials.
  • In both studies, Vabysmo was generally well-tolerated and the safety profile was consistent with previous trials.

Adverum Biotechnologies Appoints Andrew Ramelmeier, Ph.D. as Chief Technology Officer

Retrieved on: 
Monday, August 21, 2023
Vaccine, GMP, Employment, University, BioMarin Pharmaceutical, Portola Pharmaceuticals, QC, AMD, CMC, CMOS, Neovascularization, The Institute, Merck & Co., IVT, SF9, Johns Hopkins University, Patient, University of California, Berkeley, Quality control, Johnson & Johnson, Chemical engineering, Technology transfer, ChromeOS, Pharmaceutical industry, Adverum Biotechnologies, Sangamo Therapeutics

REDWOOD CITY, Calif., Aug. 21, 2023 (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 R. Andrew “Andy” Ramelmeier, Ph.D., has joined Adverum as the company’s chief technology officer.

Key Points: 
  • REDWOOD CITY, Calif., Aug. 21, 2023 (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 R. Andrew “Andy” Ramelmeier, Ph.D., has joined Adverum as the company’s chief technology officer.
  • “Ixo-vec has shown therapeutic aflibercept levels and stabilized vision in patients with wet AMD with a single IVT injection out to three years.
  • Before that, Dr. Ramelmeier held positions of increasing responsibility at several companies, including BioMarin Pharmaceuticals, Johnson & Johnson and Merck Research Laboratories.
  • He conducted post-doctoral work at The Institute of Enzyme Technology affiliated with the Heinrich-Heine-University of Dusseldorf.

New Clinical and Real-World Data for Genentech’s Vabysmo at ASRS Reveal Improved Outcomes for People With Two Leading Causes of Vision Loss

Retrieved on: 
Thursday, July 20, 2023
Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, Retina, Abstract, DME, ERM, AMD, Anatomy, Paratriathlon, Eye, Neovascularization, Diabetic retinopathy, ROG, RO, Wet, Patient, Data, Ophthalmology, Annual general meeting, United Kingdom, Society, Macular degeneration, ASRS, Update, Roche, Pharmaceutical industry, Medical imaging, Faricimab, Genentech

“The clinical and real-world data at ASRS reinforce the improvement in outcomes brought by Vabysmo in two leading causes of vision loss, particularly new analyses suggesting that Vabysmo is associated with less vision-impacting fibrosis than aflibercept,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development.

Key Points: 
  • “The clinical and real-world data at ASRS reinforce the improvement in outcomes brought by Vabysmo in two leading causes of vision loss, particularly new analyses suggesting that Vabysmo is associated with less vision-impacting fibrosis than aflibercept,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development.
  • Wet AMD and DME are two leading causes of vision loss, together affecting more than two million people in the United States and 40 million people globally.
  • Data will also further support how increased intervals between doses of Vabysmo to treat wet AMD and DME, compared to aflibercept, do not compromise outcomes.
  • Elevatum Study Design and Rationale: A Phase 4 Trial of Faricimab (VABYSMO) in Underrepresented Patients With Diabetic Macular Edema

Alvotech enters into commercialization agreement with Polifarma for proposed biosimilar to Eylea® (aflibercept)

Retrieved on: 
Wednesday, May 10, 2023
Tic, AMD, Neovascularization, Patient, Vance DeGeneres, Eye disease, Safety, Public, Pharmaceutical industry

A.S. (“Polifarma”) for the commercialization in Turkey of AVT06, a proposed biosimilar to Eylea® (aflibercept).

Key Points: 
  • A.S. (“Polifarma”) for the commercialization in Turkey of AVT06, a proposed biosimilar to Eylea® (aflibercept).
  • “It is a pleasure to join forces with Polifarma in the commercialization of a potential therapy in eye disease,” said Robert Wessman, Chairman and CEO of Alvotech.
  • This agreement with Alvotech allows us to expand our portfolio and further strengthen our position in the ophthalmology area.
  • According to the agreement, Alvotech will be responsible for development and manufacture, while Polifarma will handle market registration and commercialization.