Keratitis

Bausch + Lomb Announces Presentation of New Scientific Data and Evaluations Featuring Consumer, Vision Care and Pharmaceutical Products at Optometry’s Meeting®

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火曜日, 5月 28, 2024
Research, General Health, Pharmaceutical, Optical, Specialty, Retail, Clinical Trials, Science, Surgery, Medical Supplies, FDA, Health, The Bell Tower, Trial of the century, Viral, Bausch, Allergy, OD, Inflammation, Steroid, Fungal infection, Action, OnDemand, AOA, Telecanthus, CDT, Glaucoma, Sclera, Infection, Intraocular pressure, Contact, American Optometric Association, Conjunctiva, Cerebral edema, Music City Center, Macular edema, Complex, Eye injury, Thought, System, Employment, Convention, Contact lens, Slit lamp, Vaccinia, Patient, Incidence, Safety, Keratitis, Bausch & Lomb, Herpes simplex, Visual acuity, Taste, Iris, Eyelash, Risk, IOP, Lens (vertebrate anatomy), Astigmatism, Pigment, Efficacy, Verge, Ocular hypertension, Eye, Abstract, Human, Pain, Optic nerve, History, Palm, Chickenpox, EYE

The OnDemand ePosters will feature new data on the early adoption of MIEBO and real-world patient experiences with Bausch + Lomb INFUSE® Multifocal silicone hydrogel daily disposable contact lenses.

Key Points: 
  • The OnDemand ePosters will feature new data on the early adoption of MIEBO and real-world patient experiences with Bausch + Lomb INFUSE® Multifocal silicone hydrogel daily disposable contact lenses.
  • “Evaluation of the Efficacy of a Novel Preservative-Free Formulation of Brimonidine Tartrate Ophthalmic Solution.” Evans et al.
  • “Improvement in Non-Invasive Tear Break-Up Time after Instillation of One Drop of Brimonidine Tartrate 0.025%.” Moore et al.
  • During the event, attendees will have the opportunity to learn about Bausch + Lomb’s latest innovations, including Bausch + Lomb INFUSE® for Astigmatism and Blink NutriTears.

Provectus Biopharmaceuticals Announces Exclusive Worldwide License Agreement with University of Miami for Photodynamic Antimicrobial Treatment of Different Eye Infections with Rose Bengal Sodium

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水曜日, 3月 27, 2024
Opacity (optics), Risk, Patient, RBS, University, PDAT, Bascom Palmer Eye Institute, Rose bengal, Eye, Infection, Keratitis, Safety, Paratriathlon, Ophthalmology, OBC, Pharmaceutical industry

Provectus would contribute the license to the new entity and have an exclusive RBS supply arrangement with it.

Key Points: 
  • Provectus would contribute the license to the new entity and have an exclusive RBS supply arrangement with it.
  • Rose bengal PDAT emerged under the leadership of Jean-Marie Parel, IngETS-G, Ph.D., FARVO, Director of the Ophthalmic Biophysics Center (“OBC”) at Bascom Palmer Eye Institute (“BPEI”) at the University of Miami Miller School of Medicine.
  • The OBC team and Dr. Parel have spent many years advancing their PDAT technology using rose bengal against different types of treatment-naïve and -resistant keratitis.
  • Dr. Parel said, “Rose bengal PDAT is the result of a lot of hard work by cross-disciplinary contributors at the University of Miami.

Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector

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金曜日, 3月 1, 2024
Chorioretinitis, Natural history, Caregiver, New Drug Application, Ankylosing spondylitis, Optic neuritis, Education, FDA, Food, Adnexa, Shanda, Uveitis, Eye, Adrenocorticotropic hormone, Multiple sclerosis, Condylar resorption, Safety, Rheumatoid arthritis, Patient, Sclerosis, Disease, Keratitis, MRCP, Insurance, Pharmaceutical industry

DUBLIN, March 1, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Mallinckrodt's supplemental New Drug Application (sNDA) for the Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector (herein referred to as "SelfJect"), a new delivery device for Acthar Gel for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions.2 SelfJect is intended to provide the appropriate subcutaneous dose of Acthar Gel, as prescribed by a healthcare professional, and is designed to help give patients control of their administration.1,3

Key Points: 
  • "We're excited to bring this innovation to U.S. patients with chronic and acute inflammatory and autoimmune conditions.
  • Mallinckrodt also offers a team of field-based experts who provide education for healthcare professionals on the reimbursement process as well as tools available for patients.
  • Acthar Gel will continue to be available as an injection with a vial and syringe.
  • Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis.

Herbal medicinal product: Soiae oleum raffinatumArray, D: Draft under discussion

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土曜日, 2月 10, 2024
Peanut, Plant, Pea, Pollen, Allergy, Rash, Inflammation, Date, Infection, Committee, Heart, Monograph, Keratitis, Herbal medicine, Eye, Patient, Bath, Medicine, Accidental, Skin, Medicinal plants

Overview

Key Points: 
  • Overview
    This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of soya-bean oil.
  • The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing soya-bean oil.
  • Soya-bean oil may also be found in combination with other herbal substances in some herbal medicines.
  • Key facts
    - Latin name
    - Soiae oleum raffinatum
    - English common name
    - Soya-bean oil
    - Botanical name
    Glycine max (L.) Merr., oleum
    - Therapeutic area
    - Skin disorders and minor wounds
    - Status
    - D: Draft under discussion
    - Date added to the inventory
    - Date added to priority list
    - Outcome of European assessment
    - European Union herbal monograph

Eton Pharmaceuticals Announces Commercial Availability of Ultra-Rare Disease Product Nitisinone Capsules

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金曜日, 2月 2, 2024
Partnership, Conjunctivitis, Medicine, Inflammation, Vitamin, Thrombocytopenia, Immune system, Tyrosine, Patient, Light, Nosebleed, Intellectual disability, Itch, Ageing, Diet, Keratitis, Skin, Pharmacy, Tongue, Rash, DSM-IV codes, Allergy, Blood, Leukopenia, Photophobia, Mouth ulcer, Phenylalanine, Erythroderma, Tell, Insurance, Face, Breast milk, Plasma, Nursing

DEER PARK, Ill., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced the commercial availability of Nitisinone Capsules for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Please see important safety information below. Tyrosinemia type 1 is an ultra-rare condition that is estimated to impact fewer than 500 patients in the United States.

Key Points: 
  • We believe that our existing commercial infrastructure and strong patient support services should help us capture a meaningful percentage of the estimated $50 million annual Nitisinone market,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
  • Nitisinone Capsules are available exclusively through Optime Care, a specialty pharmacy dedicated to helping patients with rare diseases manage their conditions.
  • Optime Care will administer the Eton Cares Program in partnership with Eton Pharmaceuticals.
  • To report a suspected adverse event related to Nitisinone, contact Eton Pharmaceuticals, Inc. at: 1-855-224-0233 or the US Food and Drug Administration at www.fda.gov/medwatch or call 1-800-FDA-1088.

Dupixent® (dupilumab) U.S. Label Updated with Data Further Supporting Use in Atopic Dermatitis with Moderate-to-Severe Hand and Foot Involvement

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火曜日, 1月 16, 2024
Ageing, Regeneron Pharmaceuticals, Mouth ulcer, Patient, European, Conjunctivitis, Eosinophilia, Foot, Blepharitis, Keratitis, Walking, Aes, Skin, Food, Safety, Human, Inflammation, FDA, Physician, Bleeding, Atopic dermatitis, International development, Pharmaceutical industry

TARRYTOWN, N.Y. and PARIS, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has updated the label for Dupixent® (dupilumab) in atopic dermatitis, adding efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement. These Phase 3 data are from the first and only trial evaluating a biologic specifically for this difficult-to-treat population and have also been added to the Dupixent label in the European Union, with regulatory submissions underway in additional countries.

Key Points: 
  • These Phase 3 data are from the first and only trial evaluating a biologic specifically for this difficult-to-treat population and have also been added to the Dupixent label in the European Union, with regulatory submissions underway in additional countries.
  • “Having these data added for this difficult-to-treat population is important for physicians looking for tools to treat these patients and reinforces the already well-established efficacy and safety of Dupixent in atopic dermatitis overall.”
    The label update is based on data from the Phase 3 LIBERTY-AD-HAFT trial.
  • In the trial, patients received Dupixent (n=67) every two weeks (adults 300 mg, adolescents 200 mg or 300 mg based on body weight) or placebo (n=66).
  • Most common adverse events (AEs) observed with Dupixent (≥1%) in atopic dermatitis include injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye and eosinophilia.

Harrow Completes Transfer of NDAs and Launches FLAREX®, NATACYN®, TOBRADEX® ST, VERKAZIA®, and ZERVIATE® in the U.S.

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火曜日, 10月 24, 2023
Surgery, Medical Supplies, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Optical, New Drug Application, Full, Shirin David, Vernal keratoconjunctivitis, Tobramycin, Acquisition, VKC, Keratitis, Allergic conjunctivitis, Risk, Marketing, Cornea, Conjunctivitis, Eye, AmerisourceBergen, NDA, McKesson Corporation, Pharmaceutical industry

NATACYN® (natamycin ophthalmic suspension) 5%, a sterile antifungal for treating fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms, including Fusarium solani keratitis.

Key Points: 
  • NATACYN® (natamycin ophthalmic suspension) 5%, a sterile antifungal for treating fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms, including Fusarium solani keratitis.
  • ZERVIATE® (cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated for treating ocular itching associated with allergic conjunctivitis.
  • Harrow announced its acquisition of the U.S. commercial rights of these products in July of 2023.
  • To date, Harrow has been receiving profit transfers on these products; however, with the transfer of the NDAs completed, Harrow has launched these products in the U.S. under the Harrow name.

Seagen to Highlight Overall Survival Data for PADCEV® and TIVDAK® during Presidential Symposium at ESMO Congress 2023

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月曜日, 10月 16, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Diabetes, Fatal, Weakness, Female, Skin, PD-L1, Creatinine, DKA, Nausea, Swelling, Keratitis, Pneumonia, Birth, PD-1, Hair, Neutrophil, Male, Peripheral neuropathy, Lipase, Acute kidney injury, Blood, Stevens–Johnson syndrome, Toxic epidermal necrolysis, Diabetic neuropathy, Toxicity, Bulla, Temperature, Appetite, Itch, SJS, Fetus, Cornea, Conjunctivitis, Hyperglycemia, Dermatitis, Evaluation, Hypoxia, Pain, Diabetic ketoacidosis, Pembrolizumab, ILD, Risk, Liver, Lymphocyte, Grade 2, Rash, Erythema, Fatigue, Acral lentiginous melanoma, Pneumonitis, Papule, Incidence, Dysgeusia, Anemia, Cough, Urinary tract infection, Diarrhea, Erythroderma, Periodic breathing, TEN, Patient, MUC, PN, Drug eruption, Septic shock, Pharmaceutical industry, Medical imaging, Palladium

Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.

Key Points: 
  • Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.
  • When PADCEV was given in combination with pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate.
  • Skin reactions occurred in 72% (all grades) of the 121 patients treated with PADCEV in combination with pembrolizumab in clinical trials.
  • The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash and papular rash.

Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone

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水曜日, 10月 4, 2023
Insurance, Cornea, Keratitis, US Foods, Tyrosine, Diet, Medicine, Tell, Face, Chapter 11, Title 11, United States Code, Erythroderma, Skin, Light, DSM-IV codes, Inflammation, Carglumic acid, Mouth ulcer, Rash, Phenylalanine, Intellectual disability, Eton, Plasma, Vitamin, Hair, Photophobia, Allergy, Patient, Leukopenia, Blood, Itch, Immune system, Cover My Eyes (Pain and Heaven), Ageing, Rare, FDA, Conjunctivitis, Nosebleed, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Thrombocytopenia, Tongue, Food, Breast milk, Pharmaceutical industry, Nursing, Dietary supplement, Medical imaging, Birth control, Nitisinone

DEER PARK, Ill., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced it has entered into an agreement to acquire an abbreviated new drug application for Nitisinone Capsules via Oakrum Pharma, LLC’s Chapter 11 bankruptcy proceeding. The transaction has been approved by the bankruptcy court and is expected to be effective on October 12, 2023. The acquired product was approved by the U.S. Food and Drug Administration (FDA) in May of 2023 for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. It is estimated that less than 500 patients in the United States suffer from this ultra-rare condition.

Key Points: 
  • Nitisinone is our fourth FDA-approved product, and further advances us toward our goal of having ten commercial rare disease products on the market by the end of 2025.
  • Eton expects to launch the product in the first quarter of 2024 and plans to offer its Eton Cares support program to all patients.
  • Nitisinone is a prescription medicine used to treat adults and children with a hereditary disease called tyrosinemia type 1 (HT-1).
  • To report a suspected adverse event related to Nitisinone, contact Eton Pharmaceuticals, Inc. at: 1-855-224-0233 or the US Food and Drug Administration at www.fda.gov/medwatch or call 1-800-FDA-1088.

Prevent Blindness Declares Third Annual Inflammatory Eye Disease Awareness Week as Sept. 18 - 24

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金曜日, 9月 15, 2023
University, Visual impairment, Graves' ophthalmopathy, Social media, Eye, Conjunctivitis, Nutrient, Nebraska Medicine, University of Nebraska Medical Center, Paratriathlon, Inflammation, Professor, Improvised explosive device, Keratitis, MD, Uvea, Risk, Rheumatoid arthritis, IED, Safety, Cosmetics, Pharmaceutical industry, Uveitis, Ophthalmology, Mallinckrodt

CHICAGO, Sept. 15, 2023 /PRNewswire-PRWeb/ -- Prevent Blindness, the nation's leading eye health and safety nonprofit organization, has declared Sept. 18 – 24, 2023, as the third annual Inflammatory Eye Disease (IED) Awareness Week. IEDs include a range of conditions associated with eye inflammation.

Key Points: 
  • Prevent Blindness Offers Information on Inflammatory Eye Diseases, Including a New Video, Fact Sheets and Social Media Graphics, to Educate Public on Ways to Protect Vision and Prevent Unnecessary Vision Loss
    CHICAGO, Sept. 15, 2023 /PRNewswire-PRWeb/ -- Prevent Blindness , the nation's leading eye health and safety nonprofit organization, has declared Sept. 18 – 24, 2023, as the third annual Inflammatory Eye Disease (IED) Awareness Week.
  • Different types of IED include Uveitis , Keratitis , Conjunctivitis , Rheumatoid Arthritis , and Thyroid Eye Disease .
  • Prevent Blindness is also debuting a new episode in the online Focus on Eye Health Expert Series, " Uveitis and Inflammatory Eye Diseases ."
  • Jeff Todd, president and CEO of Prevent Blindness, interviews Steven Yeh, MD, Professor and Stanley Truhlsen Jr.