Keratitis

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

Retrieved on: 
Friday, March 1, 2024

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

Retrieved on: 
Saturday, February 10, 2024

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

Retrieved on: 
Friday, February 2, 2024

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

Retrieved on: 
Tuesday, January 16, 2024

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.

Retrieved on: 
Tuesday, October 24, 2023

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

Retrieved on: 
Monday, October 16, 2023

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

Retrieved on: 
Wednesday, October 4, 2023

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

Retrieved on: 
Friday, September 15, 2023

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.

Don't risk the health of your eyes this summer – how to correctly choose sunglasses and avoid swimming pool infections

Retrieved on: 
Wednesday, August 9, 2023

At this time of year many of us are enjoying or about to enjoy holidays – day trips, the beach, the mountains, a change of scene. Even if we don’t leave our home, summer brings with it a number of risks that can affect the health of our eyes and can spoil the season if we don’t adhere to a few basic rules and precautions.Sun radiation: how to choose the right sunglassesThis is especially true in the summer when it tends to be more intense and lasts for longer each day.

Key Points: 


At this time of year many of us are enjoying or about to enjoy holidays – day trips, the beach, the mountains, a change of scene. Even if we don’t leave our home, summer brings with it a number of risks that can affect the health of our eyes and can spoil the season if we don’t adhere to a few basic rules and precautions.

Sun radiation: how to choose the right sunglasses

    • This is especially true in the summer when it tends to be more intense and lasts for longer each day.
    • More than just a fashion accessory, sunglasses are, above all, protection for our eyes.
    • These three factors should always be conveniently marked on sunglasses if they are of high quality.
    • That’s why it is important to buy them in establishments that offer this guarantee and have specialised personnel capable of indicating the right filter for our needs.

Cold in, warm out: the fight against dry eyes

    • These create cool air currents, but they also dry out the environment and, therefore, the surface of our eyes.
    • This will help to minimise the sensation of discomfort and grit that dry eyes produces and reddening of the eyes.
    • Outdoors, high summer temperatures can also cause this uncomfortable sensation – even more so if the air is dry.

Chlorine, salt and microbes: underwater hazards

    • Water from the sea, rivers or swimming pools presents a significant risk of irritation or infection if it enters the eyes.
    • That is why we must protect them from chlorine or salt, which cause itching, burning or redness, and from microorganisms that can generate dangerous infections such as keratitis or viral or bacterial conjunctivitis.

And what if I wear contact lenses?

    • In summer, contact lenses can pose an additional risk: never swim with them in a river, swimming pool or the sea.
    • In fact, any situation in which water can enter the eye, such as taking a shower, is not recommended.
    • In 90% of the cases in which they cause infections (few, fortunately), these affect people who use contact lenses.

Harrow Acquires Santen’s Branded Ophthalmic Portfolio

Retrieved on: 
Tuesday, July 18, 2023

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

Key Points: 
  • NATACYN® (natamycin ophthalmic suspension) 5%, a sterile antifungal indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms, including Fusarium solani keratitis.
  • VERKAZIA® (cyclosporine ophthalmic emulsion) 0.1%, a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults and holds orphan-drug exclusivity.
  • ZERVIATE® (cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated with allergic conjunctivitis.
  • VERKAZIA® (cyclosporine ophthalmic emulsion) 0.1%, a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis (VKC) in children from four years of age through adolescence.