Ophthalmology News
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Aflibercept 8 mg in diabetic macular edema first to achieve sustained vision gains with up to 83% of patients extended to 16-24 weeks at two years
Data from pivotal PHOTON trial demonstrate long term efficacy of aflibercept 8 mg with extended intervals comparable to Eylea (aflibercept 2 mg) at fixed 8-weekly dosing over two years Patients assigned to a 16-week dosing regimen at baseline received a mean of 7.8 injections (6 fewer than Eylea) Safety profile of aflibercept 8 mg in diabetic macular edema (DME) remains comparable to Eylea ...
By Bayer AG
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Bayer initiates phase III study to investigate aflibercept 8 mg in retinal vein occlusion
Global phase III QUASAR study will assess the efficacy and safety of aflibercept 8 mg in macular edema secondary to retinal vein occlusion (RVO) Study comes after positive data from the phase III PULSAR trial in neovascular (wet) age-related macular degeneration (nAMD) and phase II/III PHOTON trial in diabetic macular edema (DME) QUASAR is expected to enroll around 800 patients in 27 ...
By Bayer AG
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New data from pivotal studies with aflibercept 8 mg
New Subgroup and further analyses from PULSAR, PHOTON and CANDELA provide insights into durability results of extended treatment intervals, patient characteristics as well as efficacy and safety of intravitreal aflibercept 8 mg In total, 18 presentations on aflibercept 8 mg and Eylea (aflibercept 2 mg) reinforce Bayer’s commitment to advancing treatment of patients with exudative retinal ...
By Bayer AG
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CO2 fractional laser in cosmetic dermatology
The best CO2 fractional laser machine is a common cosmetic treatment, commonly used for skin treatment such as mole removal, flat warts, acne pit scars, etc. It can also be used for facial rejuvenation such as wrinkle removal, etc. CO2 laser skin resurfacing machine is a minimally invasive laser treatment technique. Traditional CO2 laser treatment has a long recovery period and greater damage, ...
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Is the CO2 fractional laser damaging to the skin
The best fractional CO2 laser machine is a minimally invasive treatment. It works by heating the dermis and epidermis with a fractional laser, causing microscopic columnar damage to the skin, activating fibroblasts, stimulating collagen remodelling reactions, thickening the dermis and achieving cosmetic results such as wrinkle reduction, skin rejuvenation and spot removal. Today the CO2 laser ...
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Bayer submits aflibercept 8 mg for marketing authorization in Japan
Submission to the Ministry of Health, Labor, and Welfare (MHLW) in Japan for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) is based on positive results of phase III clinical trials, PULSAR and PHOTON In both trials, aflibercept 8 mg demonstrated unprecedented durability results with treatment intervals of up to 16 weeks, with ...
By Bayer AG
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Juvena Therapeutics Bolsters Leadership Team With Key Industry Veterans in Drug Discovery and Development, Data Science, and Business Development
Juvena Therapeutics, Inc. (“Juvena”), a biotechnology company scaling a computational platform to map the therapeutic potential of secreted proteins, announced today the hiring of four senior leaders with significant industry experience in both small and large pharmaceutical and biotech companies. The company plans to continue growing its team to power the expansion of Juvena’s ...
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Bayer submits aflibercept 8 mg for regulatory approval in two major retinal eye diseases in the EU
Filing for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) is based on positive results of clinical trials, PULSAR and PHOTON In both trials, aflibercept 8 mg demonstrated unprecedented durability results with treatment intervals of up to 16 weeks, with comparable visual acuity as well as rapid and resilient fluid control to the ...
By Bayer AG
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Viral Vector Manufacturing
In recent years, applications of viral vectors have found an encouraging new beginning in gene therapy and in vaccine development. What can viral vectors be used for? Substantial improvements in viral vector manufacturing, delivery, and safety have placed viral vector-based therapy at the forefront of modern medicine. Viral vectors can be used for the treatment of various ...
By Nuvonis
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ViGeneron presents preclinical data on intravitreal gene therapy of Stargardt disease at ESGCT
Efficient transfer of larger gene via ViGeneron’s proprietary technology platforms REVeRT and vgAAV ViGeneron advances its preclinical programs for Stargardt disease and Retinitis Pigmentosa into IND-enabling activities and clinical stage development ViGeneron GmbH, a next-generation gene therapy company, today announced the presentation of preclinical data on its program VG801 in ...
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ViGeneron Announces Closing of Series A Financing to Drive Development of Next Generation Gene Therapy Pipeline
ViGeneron GmbH, a gene therapy company, announced the closing of its series A financing round led by WuXi AppTec and Sequoia Capital China. The proceeds will enable ViGeneron to accelerate its proprietary viral vector-based gene therapy platforms and drive product development in its two lead ophthalmic gene therapy programs. Funds will advance development of ViGeneron’s next-generation ...
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5 Ways OCT Technology Can Benefit Your Practice
The human eye is an amazing organ. With the fastest muscle in your body, it contains 107 million cells and can differentiate approximately 10 million colors. But when it comes to detecting severe conditions like glaucoma and macular degeneration, the naked eye’s powers are limited. That’s where OCT technology comes in handy. OCTs have become a standard of care that every practice ...
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An Easy, Predictable, and Simpler Way to Embolize Tumors
Instylla is now enrolling patients in a clinical trial for the world’s first hydrogel-based liquid embolic intended for the treatment of hypervascular tumors. A second initial application for its Embrace embolic therapy is hemorrhage control, where the product offers advantages in terms of simplicity, speed, and safety. Amar Sawhney and his teams, it seems, can make medical hydrogels do ...
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BRIM Biotechnology receives FDA Orphan Drug Designation for BRM424 to treat neurotrophic keratitis
BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885) is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for BRM424 in the treatment of neurotrophic keratitis (NK), a rare degenerative eye disease which causes very severe cornea damage and can lead to loss of sight. Dr. Haishan Jang, Chairwoman and CEO of BRIM Biotechnology, ...
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Digital Diagnostics Named to the 2022 CB Insights’ Digital Health 150 List
Coralville, Iowa December 7, 2022 — Digital Diagnostics – a leading AI diagnostics company on a mission to transform global healthcare – is a recipient of CB Insights’ fourth-annual Digital Health 150. The list recognizes the 150 most promising private digital health companies of 2022. “From reimagining clinical care, to leveraging tech like AR/VR to improve ...
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Bayer receives positive CHMP opinion for Eylea in the EU for treatment of preterm infants with retinopathy of prematurity
Recommendation is based on the Phase III study FIREFLEYE and data from the follow-up study FIREFLEYE NEXT Retinopathy of prematurity (ROP) can lead to severe visual impairment and blindness Bayer will apply for a patent term extension for the patent covering aflibercept, the active ingredient in Eylea™, of six months once the European Commission adopts a decision for a label extension ...
By Bayer AG
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Detailed data from pivotal studies with aflibercept 8 mg demonstrate sustained improvements in visual acuity and anatomic measures with large majority of patients maintaining treatment intervals of 16 weeks at week 48
Aflibercept 8 mg demonstrated non-inferior vision gains to Eylea® (aflibercept 2 mg) with 83% of patients with neovascular (wet) age-related macular degeneration (nAMD) and 93% of patients with diabetic macular edema (DME) maintaining dosing intervals of 12 weeks or longer through week 48 Superior fluid control in nAMD and robust disease control through to week 48 in nAMD and DME In both ...
By Bayer AG
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Ray Therapeutics and Forge Biologics Expand Their Viral Vector cGMP Partnership to Encompass Plasmid DNA Manufacturing
Ray Therapeutics, a biotechnology company developing optogenetic gene therapies for patients with retinal degenerative conditions, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced further collaboration for their manufacturing partnership to include clinical stage plasmid DNA production to support Ray Therapeutics’ lead optogenetics ...
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Positive Data Presentations at AAO Annual Meeting Demonstrate Utility and Versatility of Clearside Biomedical’s Proprietary Suprachoroidal Space Platform
Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that clinical data from multiple internal and partnered programs were presented at the recent 2022 Annual Meeting of the American Academy of Ophthalmology (AAO), the world's largest association of eye ...
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FDA Approves Taiho’s LYTGOBI® (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma
LYTGOBI (pronounced “light-GOH-bee”) delivered an objective response rate of 42% and median duration of response of 9.7 months in the primary analysis of the pivotal clinical trial. LYTGOBI covalently binds to FGFR2 and inhibits the signaling pathway. The other approved FGFR inhibitors are reversible ATP-competitive inhibitors. LYTGOBI previously received breakthrough, orphan drug ...
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