Uveitis

United States HUMIRA Market Analysis, Size, Forecast, and Insights Report, 2019-2023 and 2024-2032 - ResearchAndMarkets.com

Retrieved on: 
Friday, March 1, 2024
Pharmaceutical, Health, Clinical Trials, Psoriatic arthritis, Ulcerative colitis, JIA, Crohn's disease, Psoriasis, Ankylosing spondylitis, Uveitis, Adalimumab, SWOT, Juvenile idiopathic arthritis, UC, AbbVie, Rheumatoid arthritis, Hidradenitis suppurativa, Clinical trial, HS, TNF, Research, Pharmaceutical industry

The "US HUMIRA Market Size, Forecast, and Market Insight - 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "US HUMIRA Market Size, Forecast, and Market Insight - 2032" report has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about HUMIRA for autoimmune uveitis in the US.
  • Further, it also consists of future market assessments inclusive of the HUMIRA market forecast analysis for autoimmune uveitis in the US, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in autoimmune uveitis.
  • What are the other emerging products available and how are these giving competition to HUMIRA for autoimmune uveitis?

Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira®

Retrieved on: 
Saturday, February 24, 2024
Biotechnology, FDA, Health, Pharmaceutical, Managed Care, Pharmacy, Ulcerative colitis, Psoriasis, Uveitis, Ankylosing spondylitis, Multimedia, TEVA, Marketing, Teva, Partnership, Food, Teva Pharmaceuticals, Volunteering, Biosimilar, IC, Safety, Juvenile idiopathic arthritis, Rheumatoid arthritis, Hidradenitis suppurativa, Patient, Prescription, Environment, Generic drug

Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.

Key Points: 
  • Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.
  • An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand name drugs.
  • As the only interchangeable adalimumab biosimilar with the high-concentration formulation, SIMLANDI can be substituted for Humira at the pharmacy level, subject to state pharmacy laws.
  • Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization, which leverages Teva’s extensive experience and sales and marketing infrastructure.

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
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.

OKYO Pharma Announces Distinguished Ophthalmologists with Expertise in the Medical and Surgical Treatment of Ocular Surface Diseases Join its Scientific Advisory Board

Retrieved on: 
Wednesday, January 31, 2024
Uveitis, Telecanthus, Research, University, Yale School of Medicine, Patient, Pain, Wilmer Ophthalmological Institute, Safety, FDA, NCP, Physician, DED, Eye, DRS, Bascom Palmer Eye Institute, Garden, Pharmaceutical industry

and Anat Galor, M.D., both from the Bascom Palmer Eye Institute, and Mark Milner, M.D., of the Goldman Eye in Palm Beach Gardens, Florida, have joined OKYO’s Scientific Advisory board.

Key Points: 
  • and Anat Galor, M.D., both from the Bascom Palmer Eye Institute, and Mark Milner, M.D., of the Goldman Eye in Palm Beach Gardens, Florida, have joined OKYO’s Scientific Advisory board.
  • Dr Victor Perez is a Director of Cornea Research at Bascom Palmer Eye Institute, at the University of Miami Miller School of Medicine.
  • He is a clinician-scientist investigator in the field of ocular immunology and ocular surface diseases and served as Director of Duke Eye Center’s Ocular Immunology Center before joining Bascom Palmer Eye Institute.
  • OKYO's Scientific Advisory Board now has an ideal blend of clinical expertise, including ocular surface disease and neuropathic corneal pain, from the leading experts in those fields."

Tarsier Pharma Receives FDA Agreement Under Special Protocol Assessment (SPA) for Tarsier-04 Phase 3 Trial of TRS01 Ophthalmic Solution for the Treatment of Non-infectious Uveitis including Uveitic Glaucoma

Retrieved on: 
Tuesday, January 16, 2024
TEL, Marketing, Protocol, Uveitis, Food, Uveitic glaucoma, SPA, FDA, Pharmaceutical industry

A SPA agreement indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of overall protocol design for a study intended to support a future marketing application.

Key Points: 
  • A SPA agreement indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of overall protocol design for a study intended to support a future marketing application.
  • "The SPA agreement with the FDA provides a clear regulatory path for TRS01.
  • Tarsier received written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the Tarsier-04 Phase 3 trial of TRS01 address objectives supporting regulatory submission and a potential future marketing application in this indication.
  • "With this swift agreement, we are now focused on gearing up preparations toward the trial start-up activities.

Alimera Sciences Appoints Todd Wood as President of U.S. Operations and Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Tuesday, December 12, 2023
Marketing, Alimera Sciences, Dermatology, Uveitis, Physician, Weight loss, Optometry, Injection, Recurrence, Allergan, Genomics, Patient, Grand Valley State University, Compensated emancipation, Employment, AbbVie, Pharmaceutical industry

Sales, Eye Care, Area Director, Facial Aesthetics and Senior Product Manager, Lumigan (glaucoma product).

Key Points: 
  • Sales, Eye Care, Area Director, Facial Aesthetics and Senior Product Manager, Lumigan (glaucoma product).
  • He most recently served as Chief Commercial Officer at Dermtech International, a leading genomics company in dermatology.
  • in business administration from Grand Valley State University, Allendale, Mich.
    “I’m looking forward to building upon Alimera’s strong foundation to establish a program for long-term success,” said Mr. Wood.
  • The Inducement Option is an inducement material to Mr. Wood entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

Oculis Announces First Patient First Visit in Phase 2b RELIEF Trial of Topical Anti-TNFα Licaminlimab (OCS-02) in Dry Eye Disease

Retrieved on: 
Thursday, December 7, 2023
Telecanthus, DED, Quality of life, Quinze-Vingts National Ophthalmology Hospital, Uveitis, Tears, MOA, Pain, Diabetic retinopathy, Inflammation, OCS, Patient, Safety, Pharmaceutical industry

The Phase 2b RELIEF trial is a multi-center, randomized, double-masked, vehicle-controlled trial evaluating the safety and efficacy of licaminlimab for the treatment of signs and symptoms in moderate- to-severe DED.

Key Points: 
  • The Phase 2b RELIEF trial is a multi-center, randomized, double-masked, vehicle-controlled trial evaluating the safety and efficacy of licaminlimab for the treatment of signs and symptoms in moderate- to-severe DED.
  • Furthermore, the trial will evaluate if patients with a specific genetic biomarker identified in a prior trial respond better to licaminlimab.
  • The trial was designed after several trials with licaminlimab in DED and Uveitis demonstrated positive findings.
  • Riad Sherif, M.D., Chief Executive Officer of Oculis, remarked: “We are very pleased to have achieved First Patient First Visit (FPFV) in the RELIEF trial as planned.

Roivant and Priovant Announce Results from Phase 2 Study of Oral Brepocitinib in Systemic Lupus Erythematosus

Retrieved on: 
Monday, November 27, 2023
Dermatomyositis, Uveitis, Hidradenitis suppurativa, Caregiver, Alopecia areata, SLE, Lupus, Calendar, NIU, Patient, Safety, Psoriasis, Ulcerative colitis, Pharmaceutical industry

Priovant plans to disclose the study data at a future date.

Key Points: 
  • Priovant plans to disclose the study data at a future date.
  • “We saw some of the highest SRI-4 responder rates ever observed in a lupus study in the active arm of this trial, along with a favorable safety and tolerability profile.
  • Unfortunately, we also saw the highest placebo response rate observed in any significant SLE study, and as such it was not possible to truly assess the impact of the drug, or to establish sufficient differentiation from other therapies in lupus patients.
  • Oral brepocitinib has demonstrated statistically significant clinically meaningful benefit in six completed placebo-controlled Phase 2 studies in psoriasis, psoriatic arthritis, alopecia areata, hidradenitis suppurativa, ulcerative colitis, and Crohn’s disease.

Sandoz launches Hyrimoz® (adalimumab) high-concentration formulation in Europe, aiming to improve patient care

Retrieved on: 
Tuesday, November 21, 2023
Rheumatoid arthritis, Crohn's disease, Novartis, Rheumatology, Patient, HCF, Adalimumab, Psoriasis, Medicine, Injection, Endocrinology, Uveitis, Ulcerative colitis, Pharmaceutical industry

The HCF formulation is administered with the familiar Hyrimoz® SensoReady® pen, aiming for an enhanced yet familiar patient experience.

Key Points: 
  • The HCF formulation is administered with the familiar Hyrimoz® SensoReady® pen, aiming for an enhanced yet familiar patient experience.
  • The launch of Hyrimoz ® HCF strengthens the Sandoz biosimilar portfolio in immunology, including Erelzi® (biosimilar etanercept), Zessly® (biosimilar infliximab) and Rixathon® (biosimilar rituximab, including rheumatoid arthritis indication).
  • Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably across a range of areas including immunology, oncology, supportive care, and endocrinology.
  • It has a leading global portfolio with eight marketed biosimilars and a further 25 assets in various stages of development.

Oculis Reports Q3 2023 Financial Results and Provides Company Update

Retrieved on: 
Wednesday, November 15, 2023
NDA, Dexamethasone, Safety, PSME, Business analyst, Telecanthus, Visual acuity, DED, CME, International, AON, IND, Investment, Uveitis, Bank statement, Net, Patient, Research, DME, Week, Hierarchy, Inflammation, Genotype, Pain, UME, Stage 2, SNP, TNF, CHF, POC, CST, International Financial Reporting Standards, OCS, Pharmaceutical industry, Life insurance, Pecten oculi, Ophthalmology

ZUG, Switzerland and BOSTON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced third quarter financial results for the period ended September 30, 2023, and an overview of the Company’s progress.

Key Points: 
  • ZUG, Switzerland and BOSTON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced third quarter financial results for the period ended September 30, 2023, and an overview of the Company’s progress.
  • Oculis anticipates first patient enrollment toward the end of 2023 and beginning of 2024 in all three pivotal trials.
  • Oculis is on track to deliver the first patient first visit before the end of 2023 with clinical data readout expected in mid-2024.
  • The Company’s management uses these measures to better analyze its financial results and better estimate its financial outlook.