Ophthalmology

Vial Announces EMR Interface with ModMed to Power Clinical Trial Patient Recruitment

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Tuesday, August 9, 2022 - 1:30am

With VialConnect , research clinics that use ModMed's EHR EMA can seamlessly filter their patient databases to streamline clinical trial study recruitment for free.

Key Points: 
  • With VialConnect , research clinics that use ModMed's EHR EMA can seamlessly filter their patient databases to streamline clinical trial study recruitment for free.
  • The ModMed interface is available to all clinics running clinical trials using VialConnect and delivers a customizable CTMS (clinical trials management system) that powers core workflows and an EMR filtering tool to sort potential trial subjects from a clinic's patient database.
  • "VialConnect's EMR filtering tool allowed us to screen patients in record time and expedited our patient recruitment timelines.
  • Vial plans to roll out the interface across the Vial Site Network that use ModMed's EMA.

Clearside Biomedical Enters into Non-Dilutive Financing Agreement with HealthCare Royalty Partners for up to $65 Million

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Monday, August 8, 2022 - 9:30pm

Under the terms of the agreement, Clearside will receive an initial payment of $32.5 million, less certain expenses.

Key Points: 
  • Under the terms of the agreement, Clearside will receive an initial payment of $32.5 million, less certain expenses.
  • The terms of the agreement also provide for an additional milestone payment of $20 million to Clearside upon attainment of a second pre-specified 2024 sales milestone for XIPERE.
  • The arrangement with HealthCare Royalty specifically excludes all Clearsides internal development programs, including CLS-AX, as well as any future in-licensed assets.
  • HEALTHCARE ROYALTY PARTNERS is a registered trademark of HealthCare Royalty Management, LLC in the U.S. and a trademark in other countries.

Design Therapeutics Highlights Upcoming Milestones and Reports Second Quarter 2022 Financial Results

Retrieved on: 
Monday, August 8, 2022 - 9:05pm

CARLSBAD, Calif., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today highlighted anticipated upcoming milestones across its clinical and research-stage pipeline of novel GeneTAC™ small molecules and reported second quarter 2022 financial results.

Key Points: 
  • CARLSBAD, Calif., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today highlighted anticipated upcoming milestones across its clinical and research-stage pipeline of novel GeneTAC small molecules and reported second quarter 2022 financial results.
  • With a financial runway to support our current multi-year operating plan, we continue to be well-positioned to execute our milestones.
  • Design expects to initiate dosing of DT-216 in the multiple-ascending dose portion of the Phase 1 study in the second half of 2022.
  • The data were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting in May 2022.

iHealthScreen Completed Prospective Trial of AI-Based Tool for Age-Related Macular Degeneration (AMD) Screening and Submitting the Results to FDA for 510K Clearance

Retrieved on: 
Monday, August 8, 2022 - 9:22pm

The initial clinical trial results show adequate accuracy for FDA clearance.

Key Points: 
  • The initial clinical trial results show adequate accuracy for FDA clearance.
  • The study was funded by NIH SBIR grants and completed with the collaboration of the New York Eye and Ear Infirmary at Mount Sinai.
  • AMD, with no early signs or symptoms, is a leading cause of adult blindness in the developed world.
  • iHealthScreen is in the final stage of submitting the results to FDA for 510K clearance.

Ocular Therapeutix™ Reports Second Quarter 2022 Financial Results and Business Update

Retrieved on: 
Monday, August 8, 2022 - 9:01pm

Net product revenue of DEXTENZA for the quarter was $12.1 million, a 9% increase over the second quarter of 2021.

Key Points: 
  • Net product revenue of DEXTENZA for the quarter was $12.1 million, a 9% increase over the second quarter of 2021.
  • Net product revenue of DEXTENZA in the second quarter of 2022 was $12.1 million versus $11.1 million in the comparable quarter of 2021, reflecting a 9% increase.
  • Non-cash charges for stock-based compensation and depreciation and amortization were $4.8 million in the second quarter of 2022 versus $4.9 million for the comparable quarter of 2021.
  • Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 4:30 pm Eastern Time to review the Company's financial results and provide a general business update.

Prominent Stanford University scientist and cellular reprogramming innovator will oversee all research for Turn Bio

Retrieved on: 
Monday, August 8, 2022 - 1:00pm

MOUNTAIN VIEW, Calif., Aug. 8, 2022 /PRNewswire/ -- Turn Biotechnologies, a cell rejuvenation company developing novel mRNA medicines to cure untreatable, age-related conditions, today announced that co-founder Vittorio Sebastiano, PhD, will become its head of research.

Key Points: 
  • Sebastiano led development of the unique mRNA-based ERA (Epigenetic Reprogramming of Aging) platform Turn Bio uses to produce tailored protein cocktails to rejuvenate targeted cells.
  • Sebastiano has served as chairman of Turn Bio's Scientific Advisory Board since he co-founded the company in 2018.
  • A Stanford School of Medicine faculty member, author of more than 50 scientific articles and frequent speaker at research conferences around the world, Sebastiano is prominent in the emerging field of cellular reprogramming.
  • His Stanford University lab pioneered the development of a new paradigm for treating aging and age-related diseases.

Prominent Stanford University scientist and cellular reprogramming innovator will oversee all research for Turn Bio

Retrieved on: 
Monday, August 8, 2022 - 1:00pm

MOUNTAIN VIEW, Calif., Aug. 8, 2022 /PRNewswire/ -- Turn Biotechnologies, a cell rejuvenation company developing novel mRNA medicines to cure untreatable, age-related conditions, today announced that co-founder Vittorio Sebastiano, PhD, will become its head of research.

Key Points: 
  • Sebastiano led development of the unique mRNA-based ERA (Epigenetic Reprogramming of Aging) platform Turn Bio uses to produce tailored protein cocktails to rejuvenate targeted cells.
  • Sebastiano has served as chairman of Turn Bio's Scientific Advisory Board since he co-founded the company in 2018.
  • A Stanford School of Medicine faculty member, author of more than 50 scientific articles and frequent speaker at research conferences around the world, Sebastiano is prominent in the emerging field of cellular reprogramming.
  • His Stanford University lab pioneered the development of a new paradigm for treating aging and age-related diseases.

Dr. Neeraj Agarwal of the Huntsman Cancer Institute to Serve as a Scientific Advisor for Vial's Oncology CRO

Retrieved on: 
Sunday, August 7, 2022 - 10:15pm

SAN FRANCISCO, Aug. 7, 2022 /PRNewswire/ -- Dr. Neeraj Agarwal will act as a scientific advisor for Vial's Oncology CRO alongside Dr. Guru Sonpavde, Dr. Arati Rao, and Dr. Antoni Ribas.

Key Points: 
  • SAN FRANCISCO, Aug. 7, 2022 /PRNewswire/ -- Dr. Neeraj Agarwal will act as a scientific advisor for Vial's Oncology CRO alongside Dr. Guru Sonpavde, Dr. Arati Rao, and Dr. Antoni Ribas.
  • Together, they will lend their expertise to the Vial team as Vial continues to expand their Oncology CRO.
  • Vial offers best-in-class trial management through one seamless system and innovative CRO services across multiple therapeutic areas, including oncology.
  • On serving as an Oncology CRO advisor, Dr. Agarwal stated, "Over the last two decades, the entire process of conducting clinical trials has exponentially grown cumbersome.

Immunovant Reports Financial Results and Recent Business Updates for the Quarter Ended June 30, 2022

Retrieved on: 
Friday, August 5, 2022 - 12:00pm

NEW YORK, Aug. 05, 2022 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, today reported recent company updates and financial results for its fiscal first quarter ended June 30, 2022.

Key Points: 
  • NEW YORK, Aug. 05, 2022 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, today reported recent company updates and financial results for its fiscal first quarter ended June 30, 2022.
  • Recent Updates and Anticipated Milestones:
    Immunovant initiated a pivotal clinical trial of batoclimab in Myasthenia Gravis in June 2022.
  • Additional Pipeline Programs: Immunovant plans on announcing two new indications for batoclimab on an investor call scheduled for Wednesday, September 7, 2022 at 8:00AM ET.
  • During this call, Immunovant also plans to announce the third indication (in addition to MG and TED) it will initiate as a pivotal trial in calendar year 2022.

Orbis and Alcon to Kick Off Two-Week Training for Caribbean Eye Care Teams to Help Fight Avoidable Blindness in Local Communities

Retrieved on: 
Thursday, August 4, 2022 - 9:35pm

FORT WORTH, Texas, Aug. 4, 2022 /PRNewswire/ -- On Monday, August 8, Orbis International, with generous support from Alcon, the global leader in eye care, will kick off its first in-person training project on board the Flying Eye Hospital – a fully accredited ophthalmic teaching hospital on board a plane – since the pandemic began. Over a two-week period, Orbis's clinical staff and Volunteer Faculty (medical experts) along with Alcon bioengineers and trainers will share their knowledge with nearly 50 ophthalmologists, ophthalmology residents, nurses and biomedical engineers from several countries throughout the Caribbean,1 helping them build skills to fight avoidable blindness in their communities.

Key Points: 
  • Simulation training allows the visiting eye care teams to grow their confidence in a training environment before moving on to real-life surgical procedures.
  • Since 1982, three generations of the Flying Eye Hospital have taken training to eye care teams in over 95 countries around the world.
  • In 2020, Orbis reimagined in-person Flying Eye Hospital trainings as virtual ones to ensure that eye care teams could still access critical training safely during the pandemic.
  • Our more than 24,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care.