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Degeneration Diabetic Articles & Analysis

16 news found

Bayer initiates phase III study to investigate aflibercept 8 mg in retinal vein occlusion

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 ...

ByBayer AG


New data from pivotal studies with aflibercept 8 mg

New data from pivotal studies with aflibercept 8 mg

New subgroup and further analyses of the pivotal studies PULSAR, PHOTON and CANDELA will provide further insights into durability results of extended treatment intervals, patient characteristics as well as efficacy and safety of aflibercept 8 mg versus aflibercept 2 mg (EyleaTM) in patients with neovascular (wet) age-related macular degeneration (nAMD) and ...

ByBayer AG


Bayer submits aflibercept 8 mg for marketing authorization in Japan

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 ...

ByBayer AG


Bayer submits aflibercept 8 mg for regulatory approval in two major retinal eye diseases in the EU

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 ...

ByBayer 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

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

The phase III PULSAR trial in neovascular (wet) age-related macular degeneration (nAMD) and phase II/III PHOTON trial in diabetic macular edema (DME) respectively met their primary endpoint of non-inferiority of aflibercept 8 mg extended dosing regimens for best corrected visual acuity (BCVA) at week 48, compared to Eylea dosed every 8 weeks, all following ...

ByBayer AG


UNITY Biotechnology Presentations at ARVO 2022 Showcase UBX1325 as an Investigational Novel Therapeutic Modality for Retinal Vascular Diseases

UNITY Biotechnology Presentations at ARVO 2022 Showcase UBX1325 as an Investigational Novel Therapeutic Modality for Retinal Vascular Diseases

(“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), ...

ByUNITY Biotechnology


UNITY Biotechnology Doses First Patient in ENVISION, the Phase 2 Study of UBX1325 in Wet Age-Related Macular Degeneration

UNITY Biotechnology Doses First Patient in ENVISION, the Phase 2 Study of UBX1325 in Wet Age-Related Macular Degeneration

(“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 suggests that ...

ByUNITY Biotechnology


UNITY Biotechnology Completes Enrollment in BEHOLD, the Phase 2 Study of Senolytic Candidate UBX1325 in Diabetic Macular Edema

UNITY Biotechnology Completes Enrollment in BEHOLD, the Phase 2 Study of Senolytic Candidate UBX1325 in Diabetic Macular Edema

(“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, has completed enrollment for the BEHOLD study, its Phase 2 clinical trial of UBX1325 in patients with diabetic macular edema (DME). “Patients with advanced retinovascular diseases, including DME, shoulder a significant burden with current ...

ByUNITY Biotechnology


UNITY Biotechnology Announces Additional Data from Phase 1 Study of UBX1325 in Advanced Vascular Eye Disease

UNITY Biotechnology Announces Additional Data from Phase 1 Study of UBX1325 in Advanced Vascular Eye Disease

24-week UBX1325 Phase 1 data presented at Angiogenesis, Exudation, and Degeneration 2022 Conference Patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD) showed improvement in visual acuity through 24 weeks following single dose of UBX1325 Phase 2 clinical studies of UBX1325 currently enrolling patients ...

ByUNITY Biotechnology


COVAXIN (BBV152) Booster Dose Study Demonstrates Robust Immune Responses and Long-Term Safety

COVAXIN (BBV152) Booster Dose Study Demonstrates Robust Immune Responses and Long-Term Safety

Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic ...

ByOcugen, Inc.


Ocugen Partner, Bharat Biotech, Announces Positive Immunogenicity and Safety Data from COVAXIN (BBV152), COVID-19 Candidate Vaccine, in Children 2 – 18 YEARS

Ocugen Partner, Bharat Biotech, Announces Positive Immunogenicity and Safety Data from COVAXIN (BBV152), COVID-19 Candidate Vaccine, in Children 2 – 18 YEARS

Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic ...

ByOcugen, Inc.


New Data Suggest COVAXIN (BBV152) Vaccine Candidate Generates Robust Immune Memory to COVID-19 and Variants of Concern for At Least Six Months After Vaccination

New Data Suggest COVAXIN (BBV152) Vaccine Candidate Generates Robust Immune Memory to COVID-19 and Variants of Concern for At Least Six Months After Vaccination

Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic ...

ByOcugen, Inc.


Ocugen, Inc. Announces U.S. FDA Acceptance of Investigational New Drug Application to Initiate a Phase 1/2 Clinical Trial for Gene Therapy Candidate OCU400 to Treat Inherited Retinal Degeneration

Ocugen, Inc. Announces U.S. FDA Acceptance of Investigational New Drug Application to Initiate a Phase 1/2 Clinical Trial for Gene Therapy Candidate OCU400 to Treat Inherited Retinal Degeneration

Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as diabetic macular edema, wet age-related macular degeneration, and diabetic ...

ByOcugen, Inc.


Ocular diseases and the rise of Biologics in the field of Ophthalmology

Ocular diseases and the rise of Biologics in the field of Ophthalmology

Treatment options for retinal diseases, such as neovascular age-related macular degeneration, diabetic retinopathy, and retinal vascular disorders, have markedly expanded following the development of anti-vascular endothelial growth factor intravitreal injection methods. ...

ByQprotyn Inc


Ocugen, Inc. Provides an Update on its Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN (BBV152)

Ocugen, Inc. Provides an Update on its Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN (BBV152)

Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic ...

ByOcugen, Inc.


UNITY Biotechnology to Present Clinical Data at the Association for Research in Vision & Ophthalmology (ARVO) 2022 Annual Meeting

UNITY Biotechnology to Present Clinical Data at the Association for Research in Vision & Ophthalmology (ARVO) 2022 Annual Meeting

(“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that clinical data results from the Phase 1 study of its lead senolytic candidate, UBX1325, in patients with diabetic macular edema and wet age-related macular degeneration will be presented at the Association for ...

ByUNITY Biotechnology

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