Retinal Diseases News
-
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
-
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
-
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
-
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
-
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
-
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 ...
-
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 ...
-
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
-
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
-
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 ...
-
Valo Announces First Patient Dosed in the OPL-0401 Phase 2 study of an oral ROCK1/2 inhibitor for the Treatment of Non-Proliferative Diabetic Retinopathy
Valo Health, Inc. (“Valo”), the technology company focused on transforming the drug discovery and development process using human-centric data and artificial intelligence, today announced that dosing has commenced in its Phase 2 study — a multi-center ...
-
Clearside Biomedical Enters into Non-Dilutive Financing Agreement with HealthCare Royalty Partners for up to $65 Million
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 it has entered into a Royalty Interest Purchase and Sale Agreement (the agreement) with HealthCare Royalty Partners (HealthCare Royalty). Clearside intends to use the proceeds from the agreement to ...
-
Digital Diagnostics Partners with Rapidly Scaling Medicare Advantage Organization, ArchWell Health
CORALVILLE, IOWA July 26, 2022 – Digital Diagnostics is proud to announce a partnership with ArchWell Health to bring IDx-DR, the autonomous AI diagnostic system for the detection of diabetic retinopathy (DR) – including diabetic macular edema (DME) – to ArchWell Health centers across the United States. “ArchWell Health is committed to improving patient outcomes and ...
-
Digital Diagnostics, Kingdom of Saudi Arabia Sign Intent to Provide Preventative Diabetic Healthcare to 35M
CORALVILLE, IOWA July 21, 2022 – Leadership from Digital Diagnostics – maker of IDx-DR, the first-ever FDA-cleared, fully autonomous AI system for the diagnosis of diabetic retinopathy – signed a memorandum of understanding (MOU) with the Kingdom of Saudi Arabia’s Ministry of Investment during a ceremonial visit with United States of America President Joe Biden. With this ...
-
Turning a Great Idea into a Successful Product: ASPIRE
For VisionQuest’s vice president and principal investigator Vinayak Joshi (PhD), the journey from idea to commercial product has led him halfway around the world. Dr. Joshi recently traveled to Malawi, Kenya, Nigeria, and Ghana as part of his efforts to commercialize ASPIRE, his device for the detection and diagnosis of malarial retinopathy. While in Africa, he met with leaders in ...
-
Eyevensys Recaps Highlights from Investigator Meeting and Presentations at the ARVO 2022 Annual Conference
Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, today provided highlights from the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Conference held in Denver, Colorado. In addition to its participation in the event, Eyevensys also held a successful meeting with principal investigators involved in ...
By Eyevensys
-
UNITY Biotechnology Presentations at ARVO 2022 Showcase UBX1325 as an Investigational Novel Therapeutic Modality for Retinal Vascular Diseases
UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, announced presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting featuring UBX1325 as a potential treatment for diabetic macular edema (DME) and wet age-related macular degeneration (AMD), as well ...
-
Eyevensys to present at The Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting
Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases today announced that the company will be presenting preclinical data on its two lead candidates for geographic atrophy (GA) and wet AMD at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting. The conference will be held May 1-4, ...
By Eyevensys
-
Lineage Announces a Fifth Cell Therapy Program: Allogeneic Photoreceptor Transplants for the Treatment of Diseases Which May Lead to Blindness
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced a new cell therapy development program: photoreceptor neural cell (PNC) transplants for the treatment of vision loss due to photoreceptor dysfunction or damage. Similar to the company’s recently announced ...
-
UNITY Biotechnology Doses First Patient in ENVISION, the Phase 2 Study of UBX1325 in Wet Age-Related Macular Degeneration
UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that the first patient has been dosed in the ENVISION study, its Phase 2 clinical trial of UBX1325 in patients with wet age-related macular degeneration (wAMD). “The clinical and preclinical data generated so far ...
Need help finding the right suppliers? Try XPRT Sourcing. Let the XPRTs do the work for you