Ciclosporin

Sight Sciences Reports First Quarter 2024 Financial Results and Reaffirms Full Year 2024 Financial Guidance

Retrieved on: 
Thursday, May 2, 2024
FDA, Hydrus, MIGS, Telecanthus, Nature, Refractive surgery, News, Research, Depreciation, Cataract, Security (finance), IOP, DED, Webcast, Growth, Environment, District court, Patent, Intraocular pressure, Patient, Court, Society, Judgement, Glaucoma, Alcon, Ciclosporin, Standard of care, GAAP, Pharmaceutical industry

Generated first quarter 2024 total revenue of $19.3 million, an increase of 2% compared to the same period in the prior year.

Key Points: 
  • Generated first quarter 2024 total revenue of $19.3 million, an increase of 2% compared to the same period in the prior year.
  • The jury found that Sight Sciences’ asserted patents were willfully infringed, and awarded monetary damages for past infringement.
  • Sight Sciences reaffirms revenue guidance expectations for full year 2024 of approximately $81.0 million to $85.0 million, representing growth of approximately 0% to 5% growth compared to 2023.
  • Sight Sciences' management team will host a conference call today, May 2, 2024, beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

Sight Sciences Announces the Results of the Three-Year Prospective GEMINI Trial and the Cross-Over Phase of the SAHARA RCT at the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting

Retrieved on: 
Tuesday, April 2, 2024
IOP, Gland, Signs, Ciclosporin, Glaucoma, LHT, Wills Eye Hospital, ASCRS, BCEC, Patient, Telecanthus, Meibomian gland dysfunction, Doctor of Philosophy, MD, GEMINI, DED, OMNI, Signs and symptoms, Safety, Poster, Pharmaceutical industry

MENLO PARK, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on developing and commercializing innovative, interventional technologies intended to transform care and improve patients’ lives, announced today that data from studies of two of its proprietary glaucoma and dry eye technologies, the OMNI Surgical System (“OMNI”) and the TearCare System (“TearCare”), will be presented in two oral presentations and two posters at this year’s ASCRS Annual meeting April 5th to 8th in Boston, MA.

Key Points: 
  • OMNI technology facilitates surgeons’ ability to perform a comprehensive, implant-free, minimally invasive glaucoma surgical procedure in adults with primary open-angle glaucoma (“POAG”).
  • Lead author: Julio Echegoyen, MD, PhD
    Localized Heat Therapy (LHT) Compared to Cyclosporine Ophthalmic Emulsion (CsA): A Subanalysis on Age, Gender, and Disease Burden (SAHARA subanalysis) – poster presentation.
  • The event will be on Saturday, April 6, 2024, from 3:45 PM to 4:30 PM ET.
  • Learn more about this and other Sight Sciences activities at ASCRS at www.sightsciences.com/ascrs

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

Most Effective Atopic Dermatitis Treatments May Also Be Most Harmful

Retrieved on: 
Wednesday, February 21, 2024
Atopic dermatitis, AAAAI, MEDLINE, Research, Multimedia, Conjunctivitis, Meta-analysis, Ciclosporin, Physician, Quality of life, Asthma, Methotrexate, Skin, Annual general meeting, GREAT, Light, Sleep, Patient, Journal, Dermatitis, The Hills Shire, Azathioprine, American Academy, Pharmaceutical industry

"Atopic dermatitis is the most common inflammatory skin condition with an increasing number of available systemic interventions.

Key Points: 
  • "Atopic dermatitis is the most common inflammatory skin condition with an increasing number of available systemic interventions.
  • Competing treatment options exist for atopic dermatitis, but uncertainty regarding their comparative effectiveness still remains, the study showed.
  • Researchers examined the benefits and harms of all systemic and phototherapy treatments for atopic dermatitis in this network meta-analysis.
  • In randomized, controlled trials addressing systemic and phototherapy treatments for atopic dermatitis from MEDLINE, EMBASE, CENTRAL, Web of Science and GREAT, researchers performed Bayesian random-effects network meta-analyses on atopic dermatitis severity, itch severity, sleep disturbance, quality of life, exacerbations and adverse events.

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024
Leptin, PD, Metabolism, Toxicity, Body composition, Ciprofloxacin, Clinical Pharmacokinetics, Water, LBW, Perfusion, LBM, Canadian International Council, AUC, PLOS One, Bariatric surgery, Clopidogrel, CYP, Breast, Health, DNA-binding protein, BMC Public Health, Pharmacology, BMI, CRP, Pharmaceutical Research (journal), Organ, Draft, Guideline, Bypass surgery, WHO, Ageing, INT, Pharmacokinetics, Liver, Bioavailability, Chronic liver disease, Human, Incidence, Committee, Absorption, TBW, Cardiovascular disease, Anatomy, CYP2C19, PBPK, Cmax, Factorization of polynomials, European, Lancet, CHMP, Journal, NASH, Pharmacotherapy, Adipose tissue, Non-alcoholic fatty liver disease, Journal of Clinical Investigation, Medication package insert, Overweight, NPS MedicineWise, Permeability, Benzodiazepine, Meta-analysis, Liver disease, Half-life, Acetylcholine, Ciclosporin, AAG, Kinetics, Midazolam, Kidney, Safety, Biomarker, Clinical Pharmacology & Therapeutics, Peptide, Classification, Hypertension, Metabolic syndrome, Acute coronary syndrome, Insulin resistance, Fatty liver disease, CYP2E1, Lithium, Body mass index, Reproduction, EMA, IBW, Injection, Anker, NCA, Enzyme, Inflammation, Cancer, Weight loss, Gastrointestinal tract, Cardiac output, Public health, Adipokine, CYP2C9, E pluribus unum, Physiology, Agency, Risk, Steroid, Lymph, CYP2D6, BSA, GI, Cytokine, Systematic review, Vaccine

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

Harrow Announces Availability of VEVYE® (Cyclosporine Ophthalmic Solution) 0.1%, the First and Only Cyclosporine-Based Product Indicated for Treating Both Signs and Symptoms of Dry Eye Disease

Retrieved on: 
Thursday, January 11, 2024
Medical Supplies, Health, FDA, Surgery, Pharmaceutical, Optical, Biotechnology, Eye, Telecanthus, Patient, Stinger, Inflammation, Paratriathlon, Life, Ciclosporin, Risk, Tears, BID, DED, Ageing, Pharmaceutical industry

VEVYE, uniquely dispensed in a 10 microliter drop, is the first and only cyclosporine‑based product indicated for treating both the signs and symptoms of dry eye disease (DED).

Key Points: 
  • VEVYE, uniquely dispensed in a 10 microliter drop, is the first and only cyclosporine‑based product indicated for treating both the signs and symptoms of dry eye disease (DED).
  • In commenting on the announcement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “We are thrilled to announce the availability of VEVYE for our customers and their patients.
  • VEVYE is powered by the unique combination of the reliable and trusted active ingredient, cyclosporine, and a water-free semifluorinated alkane delivery vehicle, perfluorobutylpentane.
  • In addition, 92% of this patient population remains un- or under-treated due to limited efficacy and poor tolerability of existing prescription and non-prescription choices.4

Human medicines European public assessment report (EPAR): Nulojix, belatacept, Date of authorisation: 17/06/2011, Revision: 21, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Urine, Medical Subject Headings, Diarrhea, Awareness, Marketing, Basiliximab, European Commission, INN, Leukopenia, Risk, Post-transplant lymphoproliferative disorder, Kidney transplantation, Infection, MPA, ATC, Pneumonia, Urinary tract infection, International, Gastroenteritis, Cytomegalovirus, Mycophenolic acid, Language, Pyelonephritis, Ciclosporin, CD86, Cancer, Basal-cell carcinoma, Transplant, Select, Committee, Patient, Human, Dehydration, Risk management, Anatomy, Medicine, Anemia, Vomiting, IIA, CHMP, CD80, Rejection, Dentistry

Human medicines European public assessment report (EPAR): Nulojix, belatacept, Date of authorisation: 17/06/2011, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Nulojix, belatacept, Date of authorisation: 17/06/2011, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Flixabi, infliximab, Date of authorisation: 26/05/2016, Revision: 24, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, Contraindication, INN, Risk, AZA, Nausea, Heart, Inflammation, Disease-modifying antirheumatic drug, Infection, Diagnosis, Risk management, Anatomy, Ulcer, IIA, CHMP, Skin, Sinusitis, ATC, Joint, Pain, Psoriatic arthritis, Drainage, European, Disease, Ageing, Human, Safety, Heart failure, Rheumatoid arthritis, Medical Subject Headings, Agency, European Commission, Immune system, Ulcerative colitis, ACR, International, Arthritis, Language, Blood, Ciclosporin, Viral, Tuberculosis, Select, Patient, Medicine, Methotrexate, Azathioprine, Common, Tumor necrosis factor, Allergy, PUVA, Glycine mollis, Headache, Abdominal pain, Ankylosing spondylitis, Spine, Chronic pain, Committee, DMARD, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Flixabi, infliximab, Date of authorisation: 26/05/2016, Revision: 24, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Flixabi, infliximab, Date of authorisation: 26/05/2016, Revision: 24, Status: Authorised

Novartis Issues Voluntary US Nationwide Recall of Two Lots of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL due to Crystallization

Retrieved on: 
Friday, November 24, 2023
Online, Sale, NDC, Research, Safety, Food, Crystallization, USP, Completeness, Liver, Regulation, Clinical trial, Patient, Pandemic, Probability, Rejection, Kidney, FDA, Marketing, Ciclosporin, Novartis, Physician, Knowledge, Letter, Government, Pharmaceutical industry, Dietary supplement

EAST HANOVER, N.J., Nov. 24, 2023 /PRNewswire/ -- Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. The issue was identified during an investigation of crystallization in a different lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL. No other Sandimmune formulations are impacted.

Key Points: 
  • The issue was identified during an investigation of crystallization in a different lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL.
  • Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.
  • Risk Statement: Crystallization of cyclosporine in Sandimmune Oral Solution is likely to result in non-uniform distribution of the cyclosporine in the product, resulting in under-dosing or over-dosing.
  • Consumers that have bottles from the recalled lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL, should contact their health care provider.