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iHealthScreen Developed and Validated Risk Prediction Models for Cardiovascular Diseases Using Individual’s Retinal Color Images and Health Data

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пятница, мая 24, 2024

iPredict™ Stroke and heart attack prediction models provide AI-based automated prediction scores for incident stroke and heart attack (i.e., myocardial infarction (MI)) which identifies the individuals who are at risk of having stroke and MI within 5 years.

Key Points: 
  • iPredict™ Stroke and heart attack prediction models provide AI-based automated prediction scores for incident stroke and heart attack (i.e., myocardial infarction (MI)) which identifies the individuals who are at risk of having stroke and MI within 5 years.
  • The iPredict stroke and MI prediction models aim to help prevent strokes and heart attacks, saving millions of people from deaths or disabilities.
  • Using the high-resolution retinal color images of the individual’s eyes and health data, the iPredict™ AI System’s stroke and MI prediction results will be available in fully automated reports in less than 60 seconds.
  • iHealthScreen company is open to partnerships for collaboration and/or co-development of its products in various territories.

Therini Bio Announces Positive Preclinical Data Supporting the Development of THN391 in Neurodegenerative Ocular Diseases

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среда, мая 8, 2024

SACRAMENTO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Therini Bio, Inc., a clinical-stage biotech company developing fibrin-targeting immunotherapies for neurodegenerative diseases driven by vascular dysfunction, today announced positive preclinical data supporting the development of its lead candidate, THN391, for the treatment of neurodegenerative ocular diseases. The data was detailed in a poster presented by Aaron Kantor, Ph.D., Head of Translational Sciences at Therini Bio, at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting in Seattle, WA, on May 7, 2024.

Key Points: 
  • SACRAMENTO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Therini Bio, Inc., a clinical-stage biotech company developing fibrin-targeting immunotherapies for neurodegenerative diseases driven by vascular dysfunction, today announced positive preclinical data supporting the development of its lead candidate, THN391, for the treatment of neurodegenerative ocular diseases.
  • Therini Bio has developed a potential first-in-class therapeutic monoclonal antibody, THN391, that is designed to selectively block fibrin-mediated neuroinflammation without interfering with fibrin’s coagulation properties.
  • In preclinical models of macular degeneration and diabetic retinopathy, THN391 and its analogs demonstrated effectiveness in protecting against vascular and neuronal degeneration.
  • “We are very encouraged by our data demonstrating the effectiveness of THN391 in rodent models of neurodegenerative ocular diseases,” said Joel Naor, M.D., Chief Medical Officer - Ophthalmology at Therini Bio.

Ocuphire Pharma Announces Presentation on APX3330 at the ARVO 2024 Annual Meeting

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понедельник, мая 6, 2024

ZETA-1 was a Phase 2, randomized, double-masked trial evaluating the efficacy and safety of oral APX3330 compared to placebo in 103 participants with DR completed in January 2023.

Key Points: 
  • ZETA-1 was a Phase 2, randomized, double-masked trial evaluating the efficacy and safety of oral APX3330 compared to placebo in 103 participants with DR completed in January 2023.
  • This 17-step person-level scale accounts for the DRSS scores of the two eyes and then anchors the step to the worse eye.
  • Fewer participants in the APX3330 group developed proliferative diabetic retinopathy (PDR) by week 24 compared to the placebo group (11% vs 26% respectively; p=0.13).
  • APX3330 showed favorable safety and tolerability, with similar ocular adverse events between APX3330 and placebo groups.

Boehringer Ingelheim shares positive results from the first study worldwide in diabetic macular ischemia

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понедельник, мая 6, 2024

Boehringer Ingelheim today presented positive data from the HORNBILL Phase I/IIa study of BI 764524, the first ever study exploring a potential treatment for people living with diabetic macular ischemia (DMI).

Key Points: 
  • Boehringer Ingelheim today presented positive data from the HORNBILL Phase I/IIa study of BI 764524, the first ever study exploring a potential treatment for people living with diabetic macular ischemia (DMI).
  • The current standard of care for advanced DR includes intravitreal anti-VEGF treatment or invasive laser treatment.
  • “Retinal non-perfusion is a key driver of vision loss in people living with diabetic retinopathy.
  • However, until the HORNBILL study, retinal non-perfusion has not been explored as a potential treatment target.”
    “Vision loss associated with retinal conditions such as diabetic retinopathy and DMI has a devastating impact on quality of life.

Ocular Therapeutix™ Announces Positive Topline Phase 1 Data for AXPAXLI™ in Diabetic Retinopathy

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четверг, апреля 18, 2024

BEDFORD, Mass., April 18, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL) (“Ocular”), a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other diseases and conditions of the eye, today announced positive topline results from the Phase 1 HELIOS study evaluating AXPAXLI versus a sham control in patients with moderately severe to severe non-proliferative diabetic retinopathy (‘NPDR’, NCT05695417) without diabetic macular edema (DME). Ocular plans to present the study results at an upcoming meeting.

Key Points: 
  • Ocular plans to present the study results at an upcoming meeting.
  • Next Steps: Positive HELIOS results support decision to move directly to a Phase 3 study with AXPAXLI in patients with NPDR, pending discussions with the FDA
    “We are pleased to announce positive topline data for AXPAXLI in patients with diabetic retinopathy.
  • “It is promising that the efficacy signals seen to date in this Phase 1 study consistently favor AXPAXLI.
  • These data demonstrated DRSS improvements and durability for up to 40 weeks,” said Dilsher Dhoot, MD.

V-me TV Unveils Exciting New Prime Time Lineup for April

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понедельник, апреля 15, 2024

MIAMI, April 15, 2024 (GLOBE NEWSWIRE) -- V-me TV, the vibrant and leading television network catering to the U.S. Hispanic audience, is thrilled to announce the launch of its new prime time lineup.

Key Points: 
  • MIAMI, April 15, 2024 (GLOBE NEWSWIRE) -- V-me TV, the vibrant and leading television network catering to the U.S. Hispanic audience, is thrilled to announce the launch of its new prime time lineup.
  • This exciting update includes the premieres of internationally acclaimed series such as "Borgen", "Carmen Curlers", "The Killing", and "Legacy" – all making their debut for the U.S. Hispanic audience.
  • Each of these titles has captivated audiences worldwide with their compelling narratives and dynamic characters.
  • V-me TV is proud to now bring these acclaimed series to its viewers, offering a diverse range of stories that resonate with the complexities and richness of the Hispanic experience.

VergeIO Introduces ioGuardian: Revolutionizing Backup and Recovery for Unprecedented Data Integrity and Accessibility

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вторник, марта 12, 2024

ioGuardian sets a new standard for backup and recovery processes by offering inline recovery capabilities, ensuring near-continuous data access without the need for traditional recovery timeframes.

Key Points: 
  • ioGuardian sets a new standard for backup and recovery processes by offering inline recovery capabilities, ensuring near-continuous data access without the need for traditional recovery timeframes.
  • Unlike conventional backup appliances that require significant downtime for data recovery, ioGuardian delivers missing data segments to virtual machines (VMs) in real time.
  • While some backup solutions offer instant recovery by restarting VMs on a backup appliance, ioGuardian's inline recovery nearly eliminates downtime.
  • By integrating advanced backup and recovery functionalities directly into VergeOS, we are setting new benchmarks for data protection and accessibility in the industry.

EQS-News: FYB201/Ranibizumab keeps gaining momentum with approvals and launches in the MENA region

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среда, марта 13, 2024

In addition, further market launches are planned in Algeria and other Gulf Cooperation Council (GCC) markets over the course of 2024.

Key Points: 
  • In addition, further market launches are planned in Algeria and other Gulf Cooperation Council (GCC) markets over the course of 2024.
  • This strategic collaboration aims to improve access to ophthalmic treatments in the MENA region.
  • Biosimilar and specialty medicines are integral to MS Pharma product portfolio and play a crucial role in advancing our growth objectives in the MENA region.
  • This approval supports the company's commitment to the Saudi market and its broader strategic initiatives within the kingdom."

Ocuphire Pharma Announces Financial Results for Fourth Quarter and Full Year 2023 and Provides Corporate Update

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пятница, марта 8, 2024

In October 2023, Ocuphire held an End-of-Phase 2 meeting with the FDA and aligned on the registrational primary endpoint of 3-step or more worsening on binocular DRSS Person scale.

Key Points: 
  • In October 2023, Ocuphire held an End-of-Phase 2 meeting with the FDA and aligned on the registrational primary endpoint of 3-step or more worsening on binocular DRSS Person scale.
  • In February 2024, Ocuphire submitted a Special Protocol Assessment (“SPA”) to seek agreement on the clinical trial protocol and statistical analysis plan for Phase 3.
  • In September 2023, Ocuphire and Viatris, Inc. (“Viatris”) announced FDA approval of PS under the brand name RYZUMVI™ for the treatment of pharmacologically-induced mydriasis.
  • Financial Highlights for the Fourth Quarter and Full Year Ended December 31, 2023
    As of December 31, 2023, Ocuphire had cash and cash equivalents of approximately $50.5 million.

EYLEA® HD (aflibercept) Injection 8 mg Pivotal Data in Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME) Published in The Lancet

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пятница, марта 8, 2024

TARRYTOWN, N.Y., March 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced The Lancet published one-year results from the pivotal PULSAR and PHOTON trials for EYLEA® HD (aflibercept) Injection 8 mg. Specifically, the publications detailed data demonstrating that EYLEA HD extended dosing regimens were non-inferior to EYLEA® (aflibercept) Injection 2 mg for both the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).

Key Points: 
  • Specifically, the publications detailed data demonstrating that EYLEA HD extended dosing regimens were non-inferior to EYLEA® (aflibercept) Injection 2 mg for both the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).
  • “Less than a year after its approval, EYLEA HD has already made an impact in the treatment of wet age-related macular degeneration and diabetic macular edema.
  • EYLEA HD has provided disease control for my tough-to-treat cases of diabetic eye disease and allowed both my diabetic and wet age-related macular degeneration patients to enjoy less frequent dosing with a similar safety profile to EYLEA.”
    PULSAR and PHOTON are two double-masked, active-controlled pivotal trials evaluating EYLEA HD compared to EYLEA.
  • In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD.