ISEE

Iveric Bio Announces Vision Loss Reduction Data in Geographic Atrophy from Avacincaptad Pegol GATHER Trials

Retrieved on: 
Wednesday, March 1, 2023
Health, Other Science, General Health, Clinical Trials, Research, Science, Biotechnology, Visual impairment, ISO 3166-2:MG, Association for Research in Vision and Ophthalmology, Paratriathlon, Annual general meeting, ACP, Patient, Partner (business rank), Geographic atrophy, GA, Nature, ISEE, Multimedia, Clinical research, ARVO, Pharmaceutical industry, MD, Ophthalmology

IVERIC bio, Inc. (Nasdaq: ISEE) today announced an exploratory time-to-event analysis from the avacincaptad pegol (ACP) GATHER clinical trial program evaluating reduction in vision loss with ACP 2 mg versus sham treatment.

Key Points: 
  • IVERIC bio, Inc. (Nasdaq: ISEE) today announced an exploratory time-to-event analysis from the avacincaptad pegol (ACP) GATHER clinical trial program evaluating reduction in vision loss with ACP 2 mg versus sham treatment.
  • The GATHER1 and GATHER2 clinical trials were designed to evaluate the rate of geographic atrophy (GA) lesion growth in patients with GA secondary to age-related macular degeneration.
  • The post-hoc analysis for vision loss from these pivotal studies signals up to a 59% reduction in rate of vision loss with ACP 2 mg compared to sham treatment at 12 months.
  • This post-hoc analysis evaluates the potential vision loss signal through 12 months of treatment and is exploratory in nature.

Iveric Bio Reports Fourth Quarter and Full Year 2022 Operational Highlights and Financial Results

Retrieved on: 
Wednesday, March 1, 2023
FDA, Health, Clinical Trials, Pharmaceutical, Optical, Biotechnology, Opus, Clinical trial, Retina, Visual impairment, PDUFA, Safety, BTD, ISO 3166-2:MG, Advisory Committee, OLE, Research, Silicon, European Medicines Agency, ACP, IND, Paratriathlon, Patient, STAR, Maas, NDA, MHRA, AMD, Geographic atrophy, GA, EMA, File, Association for Research in Vision and Ophthalmology, International, Stargardt, Sale, ISEE, External commercial borrowing, D, Breakthrough therapy, HTRA1, Cryptocurrency, Pharmaceutical industry, MD

IVERIC bio, Inc. (Nasdaq: ISEE) today announced financial and operating results for the fourth quarter and full year ended December 31, 2022 and provided a general business update.

Key Points: 
  • IVERIC bio, Inc. (Nasdaq: ISEE) today announced financial and operating results for the fourth quarter and full year ended December 31, 2022 and provided a general business update.
  • The NDA has been granted priority review with a Prescription Drug User Fee Act (PDUFA) goal date of August 19, 2023.
  • Iveric Bio will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update.
  • A live, listen-only audio webcast of the conference call can be accessed on the Investors section of the Iveric Bio website at www.ivericbio.com .

Iveric Bio to Present at the Cowen 43rd Annual Health Care Conference

Retrieved on: 
Tuesday, February 28, 2023
Health, Research, Pharmaceutical, Science, Optical, Biotechnology, Retina, ISEE, Conference, Pharmaceutical industry

IVERIC bio, Inc. (Nasdaq: ISEE) announced today that Glenn P. Sblendorio, Chief Executive Officer, and Pravin U. Dugel, M.D., President, will participate in a fireside chat at the Cowen 43rd Annual Health Care Conference on Tuesday, March 7, 2023, at 2:50 p.m. Eastern Time.

Key Points: 
  • IVERIC bio, Inc. (Nasdaq: ISEE) announced today that Glenn P. Sblendorio, Chief Executive Officer, and Pravin U. Dugel, M.D., President, will participate in a fireside chat at the Cowen 43rd Annual Health Care Conference on Tuesday, March 7, 2023, at 2:50 p.m. Eastern Time.
  • Investors and the general public are invited to access the live webcast of the fireside chat on the Investor / Events & Presentations section of the Iveric Bio website at www.ivericbio.com .
  • An archived replay of the on-demand presentation will be available on the Company’s website immediately following the conference and for at least 30 days thereafter.
  • Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs.

Fujitsu and Tokai National Higher Education and Research System sign partnership to create wellbeing society and develop space technologies, contribute to the achievement of the SDGs and Society 5.0

Retrieved on: 
Friday, February 24, 2023
Institutionalisation, Development, Radiation, Society, Forecasting, Cabinet, Weather, Creation, Tokai National Higher Education and Research System, Research, Life, Partnership, Social Problems, Sustainable Development Goals, Nagoya University, Data analysis, Patient, Fujitsu, Frailty, Health informatics, Education, AI, Healthy Living, Attention, ISEE, Moon, Community, Tourism, Medical device, Communications satellite, Mars

As part of their partnership, Fujitsu and THERS will work toward the realization of a wellbeing society through the creation of a virtuous cycle model of community-based health and medical care in the Japanese Tokai region (2).

Key Points: 
  • As part of their partnership, Fujitsu and THERS will work toward the realization of a wellbeing society through the creation of a virtuous cycle model of community-based health and medical care in the Japanese Tokai region (2).
  • The two parties will further collaborate on the development of space technologies including systems for space weather forecasting to solve challenges related to human exploration of outer space.
  • (Source: Japanese Cabinet Office, www8.cao.go.jp/cstp/english/society5_0/index.html）
    Subregion of the Japanese Chubu and Kansai region, including Shizuoka, Aichi, Gifu and Mie prefectures.
  • Name will be changed from Center for Healthcare Information Technology to Center for Research, Education, and Development for Healthcare Life Design due to organizational reform in April 2023.

Iveric Bio to Report Fourth Quarter and Full Year 2022 Financial Results and Host Conference Call on Wednesday, March 1, 2023

Retrieved on: 
Wednesday, February 22, 2023
Health, Research, Pharmaceutical, Science, Optical, Biotechnology, International, ISEE, Webcast, Cryptocurrency, Video game

IVERIC bio, Inc. (Nasdaq: ISEE) today announced that it will report its fourth quarter and full year 2022 financial and operating results on Wednesday, March 1, 2023.

Key Points: 
  • IVERIC bio, Inc. (Nasdaq: ISEE) today announced that it will report its fourth quarter and full year 2022 financial and operating results on Wednesday, March 1, 2023.
  • Following the announcement, the Iveric Bio management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company’s financial results and provide a general business update.
  • To participate in this conference call, dial 1-888-317-6003 (USA) or 1-412-317-6061 (International), passcode 1375589.
  • A live, listen-only audio webcast of the conference call can be accessed on the Investors section of the Iveric Bio website at www.ivericbio.com .

Iveric Bio Announces FDA Accepts New Drug Application and Grants Priority Review for Avacincaptad Pegol for the Treatment of Geographic Atrophy

Retrieved on: 
Thursday, February 16, 2023
FDA, Health, Clinical Trials, Pharmaceutical, Optical, Biotechnology, New Drug Application, ACP, NDA, Advisory Committee, PDUFA, Safety, Breakthrough therapy, AMD, Priority review, GA, Patient, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ISEE, Geographic atrophy, Pharmaceutical industry

IVERIC bio, Inc. (Nasdaq: ISEE) today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted the company’s New Drug Application (NDA) for avacincaptad pegol (ACP), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD).

Key Points: 
  • IVERIC bio, Inc. (Nasdaq: ISEE) today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted the company’s New Drug Application (NDA) for avacincaptad pegol (ACP), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD).
  • The NDA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of August 19, 2023.
  • The company also announced that, at this time, the FDA has not identified any potential review issues and the FDA is not currently planning to hold an Advisory Committee meeting for ACP.
  • “The FDA’s acceptance of our NDA and Priority Review for avacincaptad pegol bring us another significant step closer to delivering a much-needed treatment to AMD patients living with GA,” said Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio.

Iveric Bio Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Thursday, February 2, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Optical, General Health, Health, Retina, Employment, ISEE, Pharmaceutical industry

IVERIC bio, Inc. (NASDAQ: ISEE) today reported that on February 1, 2023, the Company granted equity-based awards pursuant to the Company’s 2019 Inducement Stock Incentive Plan to 16 newly-hired, non-executive employees.

Key Points: 
  • IVERIC bio, Inc. (NASDAQ: ISEE) today reported that on February 1, 2023, the Company granted equity-based awards pursuant to the Company’s 2019 Inducement Stock Incentive Plan to 16 newly-hired, non-executive employees.
  • The inducement grants consisted of non-statutory stock options to purchase 368,000 shares of the Company’s common stock and 40,550 restricted stock units for shares of the Company’s common stock.
  • A tranche of 2,650 restricted stock units vests with respect to 100% of the shares underlying the units on April 1, 2023.
  • The inducement grants are subject to the terms and conditions of award agreements covering the grants and the Company’s 2019 Inducement Stock Incentive Plan.

Iveric Bio Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Wednesday, January 4, 2023
Health, Other Science, Research, Science, Pharmaceutical, Optical, Biotechnology, Retina, Employment, ISEE

IVERIC bio, Inc. (NASDAQ: ISEE) today reported that on January 3, 2023, the Company granted equity-based awards pursuant to the Company’s 2019 Inducement Stock Incentive Plan to twelve newly-hired, non-executive employees.

Key Points: 
  • IVERIC bio, Inc. (NASDAQ: ISEE) today reported that on January 3, 2023, the Company granted equity-based awards pursuant to the Company’s 2019 Inducement Stock Incentive Plan to twelve newly-hired, non-executive employees.
  • The inducement grants consisted of non-statutory stock options to purchase 250,000 shares of the Company’s common stock and 20,550 restricted stock units for shares of the Company’s common stock.
  • The inducement grants are subject to the terms and conditions of award agreements covering the grants and the Company’s 2019 Inducement Stock Incentive Plan.
  • Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs.

Iveric Bio Announces the Addition of Pravin U. Dugel, MD, to its Board of Directors

Retrieved on: 
Tuesday, January 3, 2023
Health, Other Science, Research, Science, Pharmaceutical, Optical, Biotechnology, UCLA School of Nursing, Geographic atrophy, Bascom Palmer Eye Institute, Partner (business rank), American Academy of Ophthalmology, AAO, Research, Knowledge, Residence hall director, Founding, ISEE, Patient, Faculty, American Academy, AMD, Keck School of Medicine of USC, Society, ASRS, USC Eye Institute, Columbia University, University, University of Southern California, Praveen, United Kingdom, David Geffen School of Medicine at UCLA, Doctor of Philosophy, Retina, ACP, Management, Pharmaceutical industry, MD, Czechoslovakia, Ophthalmology

IVERIC bio, Inc. (Nasdaq: ISEE) announced today the election of Pravin U. Dugel, MD, President of Iveric Bio, to its Board of Directors, effective as of January 1, 2023.

Key Points: 
  • IVERIC bio, Inc. (Nasdaq: ISEE) announced today the election of Pravin U. Dugel, MD, President of Iveric Bio, to its Board of Directors, effective as of January 1, 2023.
  • “On behalf of the entire Board of Directors, we are excited to have Pravin join our board during this pivotal time as the Company prepares for a potential approval and commercial launch of ACP in geographic atrophy,” stated Adrienne L. Graves, PhD, Chairman of the Board of Iveric Bio.
  • “Pravin is an exceptional leader whose skills as an executive and extensive knowledge as a retinal specialist provide a valued perspective that will enhance the collective experience of our Board,” stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio.
  • “I enjoy working closely with Pravin and now look forward to working with him in his added role as a board member.

Iveric Bio Announces Completion of Rolling NDA Submission to FDA for Avacincaptad Pegol for the Treatment of Geographic Atrophy

Retrieved on: 
Tuesday, December 20, 2022
Biotechnology, FDA, Pharmaceutical, Health, ISEE, EMA, Blood, Security (finance), Patient, Atrophy, Food, IOP, ACP, CNV, Disease, Geographic atrophy, FDA Special Protocol Assessment, Retina, Growth, Endophthalmitis, Marketing, FDA, Safety, Inflammation, Clinical trial, C5, AMD, Ageing, NDA, European Medicines Agency, Severe cognitive impairment, Vasculitis, Breakthrough therapy, Scar, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Chemistry, Pharmaceutical industry

Per the company’s agreement with the FDA for rolling NDA review, part 3 of the NDA included chemistry, manufacturing, and controls data.

Key Points: 
  • Per the company’s agreement with the FDA for rolling NDA review, part 3 of the NDA included chemistry, manufacturing, and controls data.
  • “We are excited to have submitted our complete NDA for avacincaptad pegol with a request for priority review based on our Breakthrough Therapy designation,” said Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio.
  • In addition, ACP is the first and only investigational therapy to receive Breakthrough Therapy designation for GA secondary to AMD.
  • There are currently no U.S. FDA or European Medicines Agency (EMA) approved treatment options available for patients with geographic atrophy secondary to AMD.