Retinal

FDA Grants AI-Powered Notal Vision Home OCT "SCANLY" De Novo Marketing Authorization

Retrieved on: 
torsdag, maj 16, 2024
Cloud, Insurance, Patient, Retina, Doctor of Philosophy, HRS, NOA, AMD, Neovascularization, Medicare, Health, Randomized controlled trial, OCT, Retinal, FDA, Digital, CPT, Disease, MD, De novo, Biomarker, Physician, Artificial intelligence, Home, TRO, Ophthalmology, Medical imaging

First-ever home retinal imaging service to monitor wet AMD, the leading cause of blindness for older patients

Key Points: 
  • Manassas, Virginia--(Newsfile Corp. - May 16, 2024) - Digital healthcare provider, Notal Vision, announced today that the US Food and Drug Administration (FDA) has granted De Novo authorization for its patient self-operated SCANLY® Home OCT device.
  • SCANLY captures spectral-domain optical coherence tomography (OCT) images in a 10 by 10-degree area centered on the point of fixation.
  • The proprietary, artificial intelligence (AI)-based Notal OCT Analyzer (NOA) segments and estimates the volume of hypo-reflective spaces (HRS)-important biomarkers in managing nvAMD-on OCT images.
  • Notal Vision's SCANLY Home OCT has the potential to support current and future advances in retinal disease management.

Clearside Biomedical Announces Publication of Consensus Guidelines for Drug Delivery via Suprachoroidal Space (SCS®) Injection in Leading Peer-Reviewed Industry Journal, RETINA®

Retrieved on: 
tisdag, maj 21, 2024
MPH, Diabetic retinopathy, SCS, Ophthalmology, Retinal, FDA, MBA, Eye, Pharming, Journal, Retina, Physician, Vaccine

ALPHARETTA, Ga., May 21, 2024 (GLOBE NEWSWIRE) -- 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 that RETINA®, The Journal of Retinal and Vitreous Diseases, has published new guidelines that represent best practices for injection into the suprachoroidal space.

Key Points: 
  • The publication, entitled, “Suprachoroidal Space Injection Technique: Expert Panel Guidance” was co-authored by 16 practicing retinal physicians led by Charles C. Wykoff, MD, PhD, Retinal Consultants of Texas, Houston, TX.
  • The guidance was developed based on current published evidence and clinical experience.
  • The panel established consensus on the rationale for SCS injection, including potential benefits relative to other intraocular delivery methods, and current best practices in patient preparation, pre- and peri-injection management, SCS specific injection techniques, and post-injection management and follow-up.
  • Extensive evidence support its safe and effective implementation in routine clinical practice.

Outlook Therapeutics® to Present at the Retina World Congress 2024

Retrieved on: 
torsdag, maj 2, 2024
AMD, FDA, Outlook, European Commission, Bevacizumab, Patient, Physician, Therapy, Retina, Retinal

ISELIN, N.J., May 02, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced it will present at the 2024 Retina World Congress being held May 9-12, 2024 in Fort Lauderdale, FL.

Key Points: 
  • ISELIN, N.J., May 02, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced it will present at the 2024 Retina World Congress being held May 9-12, 2024 in Fort Lauderdale, FL.
  • Details for the presentations are as follows:
    As part of the panel, Mr. Trenary will discuss Outlook Therapeutics’ ONS-5010/LYTENAVA™, an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment of wet AMD and other retinal diseases.
  • If approved, ONS-5010/LYTENAVA™ would provide an approved option for physicians to treat wet AMD.
  • For more information and to register for this event, please visit Retina World Congress .

Ocular Therapeutix™ Strengthens Clinical Team with Appointment of Key Retinal Leaders

Retrieved on: 
tisdag, april 16, 2024
Retina, AMD, FDA, CMO, CDO, Diabetic retinopathy, Doctor of Philosophy, OD, Appointment, Patient, MPH, CSO, Health, Diabetes, Clinical trial, Quality of life, Retinal, Nursing

BEDFORD, Mass., April 16, 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, and other diseases and conditions of the eye, today announced that it has strengthened its clinical development organization with the appointment of Nadia K. Waheed, MD, MPH, as Chief Medical Officer (CMO); Peter K. Kaiser, MD as Chief Development Officer (CDO); Andrea Gibson, Ph.D., as Vice President, Medical Collaborations; and Namrata Saroj, OD, as Development Strategy Consultant. Dr. Waheed’s appointment will be effective as of May 20, 2024. Jeffrey S. Heier, MD, will continue in his role as Chief Scientific Officer (CSO).

Key Points: 
  • “I am thrilled to announce the enrichment of Ocular’s clinical development organization with the appointment of four recognized retinal disease professionals.
  • Having a strong team of retinal leaders with experience across all aspects of clinical development is essential to Ocular’s transformation to becoming a leading retina company,” said
    Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix.
  • In addition, I believe our strengthened clinical team also puts Ocular in an excellent position to accelerate expansion into retinal indications beyond wet AMD, including diabetic retinopathy.”
    Dr. Waheed said, “I am honored to be part of the Ocular Therapeutix team.
  • I joined Ocular because I believed that AXPAXLI could be a ‘game-changer’ in the care of retinal disease.

Bausch + Lomb Will Present New Scientific Data and Analyses at the American Society of Cataract and Refractive Surgery Annual Meeting

Retrieved on: 
onsdag, mars 27, 2024
Science, Other Science, Research, Pharmaceutical, Optical, Surgery, General Health, Health, Momentum, YAG, Toric, Failure, IOP, Retinal, Glaucoma, Exercise, DSM-IV codes, Neuropathic pain, ASCRS, History, Sale, Contact, Dry, Refraction, Bausch & Lomb, Eye, System, Keratoconus, Medication discontinuation, Pain, Corneal topography, Telecanthus, Astigmatism, Aphakia, Correction, Uveitis, Surgeon, Diabetes, Risk, Eye injury, CTK, Retinal detachment, Side, Trial of the century, Visual acuity, Diagnosis, Safety, Contraindication, Emmetropia, Vision, Taste, Dry eye syndrome, Intraocular lens, Presbyopia, Real, Floater, Magnetic resonance, Contrast (vision), Human, GLARE, Infection, Use, FDA, Ranibizumab, Muscular dystrophy, Sickle cell disease, Refractive surgery, Retina, Direction, IDE, Allergy, User, Society, Bleeding, Autoimmune disease

In addition to these scientific presentations, the company will also sponsor educational events focused on these and other Bausch + Lomb products.

Key Points: 
  • In addition to these scientific presentations, the company will also sponsor educational events focused on these and other Bausch + Lomb products.
  • Bausch + Lomb activities at ASCRS:
    “Assessment of the Spectacle Independence and Visual Outcomes Following Bilateral Implantation of a Novel Toric IOL* Among Cataract Patients.” Harasymowycz et al.
  • “Outcomes of an Ultra-Low Cylinder Powered (0.90 D) Toric versus Non-Toric IOL in Low Astigmatic Patients Undergoing Cataract Surgery.” Muzychuk et al.
  • “Quality of Vision and Clinical Outcomes of a Novel Trifocal IOL* Implanted Bilaterally After Cataract Surgery: A Canadian Multicenter Study.” Harasymowycz et al.

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

Retrieved on: 
fredag, mars 8, 2024
FACS, Regeneron Pharmaceuticals, Research, HD, Food, Floater, Cataract, Consultant, Aflibercept, Diabetic retinopathy, European, Intraocular pressure, Safety, DR, Society, Retinal, Bayer, Diabetes, Patient, Publication, Pharmaceutical industry

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.

Sandoz acquires CIMERLI® business from Coherus, further building biosimilar and ophthalmology leadership in US market

Retrieved on: 
måndag, mars 4, 2024
Paratriathlon, Acquisition, United, Ophthalmology, Retina, Retinal, Patient, Disability, USD, Generic drug

Dedicated retina sales and field reimbursement team integrated into Sandoz, ensuring seamless experience for providers and patients

Key Points: 
  • Dedicated retina sales and field reimbursement team integrated into Sandoz, ensuring seamless experience for providers and patients
    Basel, March 4, 2024 – Sandoz, the global leader in generic and biosimilar medicines, has completed the acquisition of the US biosimilar CIMERLI®* (ranibizumab-eqrn) from Coherus BioSciences, Inc, ahead of anticipated timelines.
  • The acquisition builds on the leading Sandoz ophthalmic platform in the US and lays an even stronger foundation for future product launches.
  • Keren Haruvi, President Sandoz North America said: “Today we further expand the Sandoz biosimilar portfolio, while advancing our mission in the US of pioneering patient access to more affordable and much-needed medicines.
  • The transaction includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software.

Global Retinal Surgery Devices Markets Forecast to 2030 - Company Profiles, Major Deals, Strategy and Recent Developments, Featuring Alcon, Carl Zeiss Meditec, Iridex, Lumenis, Optos & Nidek - ResearchAndMarkets.com

Retrieved on: 
fredag, februari 16, 2024
Optical, Health, Surgery, Medical Devices, Therapy, Diabetic retinopathy, Incidence, Retina, Retinal detachment, Growth, Prevalence, Instrument, Diabetes, Disease, Paratriathlon, Retinal, Vitrectomy, Dentistry

The "Global Retinal Surgery Devices Market (By Device Segment, Application, Regional Analysis), Company Profiles, Major Deals, Strategy and Recent Developments - Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Retinal Surgery Devices Market (By Device Segment, Application, Regional Analysis), Company Profiles, Major Deals, Strategy and Recent Developments - Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.
  • The global retinal surgery devices market is projected to reach US$ 4.71 Billion by 2030.
  • The global retinal surgery devices market is mainly driven by the increasing prevalence of ophthalmic conditions, especially diabetic retinopathy.
  • This report has been analyzed from 8 viewpoints:
    Global Retinal Surgery Devices Market - Company Profiles, Major Deals, Strategy, Sales, Recent Developments

Opthea Strengthens Team with Key Clinical and Regulatory Hires

Retrieved on: 
torsdag, februari 1, 2024
Growth, Novartis, Drug, AMD, Food and Drug Administration, Ophthalmology, Medicinal chemistry, Patient, Wake Forest University, FDA, Doctor of Pharmacy, Geographic atrophy, SVP, Retina, Food, Drug development, Doctor of Philosophy, ASX, Retinal, China Pharmaceutical University, U.S. FDA

MELBOURNE, Australia, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; NASDAQ:OPT, “Opthea”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, today announced the appointment of Julie Clark, MD, MS, as Senior Vice President (SVP), Clinical Development, and Fang Li, Ph.D. RAC, as SVP, Regulatory Affairs, effective February 1, 2024. Dr. Clark and Dr. Li will report to Opthea Chief Executive Officer, Frederic Guerard, PharmD, MS, and will join the Opthea Executive Management Team.

Key Points: 
  • Dr. Clark and Dr. Li will report to Opthea Chief Executive Officer, Frederic Guerard, PharmD, MS, and will join the Opthea Executive Management Team.
  • The majority of my career has been dedicated to the clinical development of novel therapies for retinal diseases.
  • She has held key roles at prominent ophthalmology companies such as Novartis AG, Alcon Inc., and Bausch + Lomb Corporation.
  • Dr. Li's extensive background includes significant involvement in health authority interactions, U.S. FDA advisory committee meeting preparation and the establishment and leadership of regulatory teams.

SightMD New York Welcomes Clearview Eye Surgery to It's Expert Team

Retrieved on: 
torsdag, januari 25, 2024
Family, Patient, Cataract, United States Army, Blepharoplasty, Health, Contact, Trust, Stony Brook University, Partnership, Retina, Eye, Retinal, Communication, Diabetic retinopathy, PHD, Macular degeneration, Strabismus, Suite, Acquisition, Bachelor of Science, Glaucoma, DSM-IV codes, OD, Gettysburg College, Diagnosis, Physician

HAUPPAUGE, N.Y., Jan. 25, 2024 /PRNewswire-PRWeb/ -- SightMD New York, a leading multi-specialty ophthalmology platform, announced a strategic partnership with Clearview Eye Surgery. Through this strategic partnership Clearview's practice locations at 1825 Riverside Drive, Suite 1B New York, NY 10034, 1200 Waters Place, Suite 304 Bronx, NY 10461 and 132-15 41st Avenue CC Flushing , NY 11355 will expand SightMD's presence by adding three locations and five providers, growing SightMD's current footprint to 40+ locations and 85+ providers across New York.

Key Points: 
  • HAUPPAUGE, N.Y., Jan. 25, 2024 /PRNewswire-PRWeb/ -- SightMD New York, a leading multi-specialty ophthalmology platform, announced a strategic partnership with Clearview Eye Surgery.
  • - Dr. John J. Kim, Founder of Clearview Eye Surgery
    "We are excited to welcome Clearview Eye Surgery into the SightMD family.
  • Clearview Eye Surgery is dedicated to providing state of the art, professional and personalized eye care to all of our patients to ensure the best possible outcome.
  • Thousands of people have trusted their award-winning team with their families' eye care and vision correction treatment, and we are grateful for the opportunity to have them join the expert team at SightMD.