DED

OKYO Pharma Announces OK-101 Successfully Achieved Statistical Significance for Both Sign and Symptom Endpoints in its First-in-Human Phase 2 Trial of OK-101 in Patients with Dry Eye Disease

Retrieved on: 
måndag, januari 8, 2024
Patient, DED, BID, Plasma protein binding, Dry, FDA, Ophthalmology, Medical director, Lubrication, Human, Ora, Telecanthus, B cell, Safety, Conjunctiva, Pharmaceutical industry

This first-in-human trial of OK-101 established a clear and informed path for further development in Phase 3 registration trials.

Key Points: 
  • This first-in-human trial of OK-101 established a clear and informed path for further development in Phase 3 registration trials.
  • The double-masked, randomized, placebo-controlled Phase 2 trial was conducted at six sites in the U.S. and enrolled 240 subjects with DED dosed twice-daily (BID).
  • OK-101 First-In-Human trial establishes a clear clinical path for further clinical development in a Phase 3 study design using FDA recognized endpoints per the Dry Eye: Developing Drugs for Treatment Guidance for Industry.
  • A statistically significant improvement in blurred vision was also achieved at Day 29 (p = 0.01).

OKYO Pharma to Present at the Biotech Showcase Conference in San Francisco, January 8-10, 2024

Retrieved on: 
fredag, januari 5, 2024
DED, Partnership, FDA, Telecanthus, Patient, Pharmaceutical industry

The OKYO management team will also be participating in one-on-one partnering meetings throughout the conference.

Key Points: 
  • The OKYO management team will also be participating in one-on-one partnering meetings throughout the conference.
  • OKYO Pharma has just completed a phase 2, multi-center, double-masked, placebo-controlled trial of topical ocular OK-101 to treat 240 patients with dry eye disease (DED).
  • The conference takes place each year in San Francisco during the course of one of the industry's largest gatherings and busiest weeks.
  • “We are delighted that OKYO Pharma will be joining us in San Francisco and presenting at Biotech Showcase this year,” said Sara Demy, CEO of Demy-Colton.

Harrow Partners with Leading Healthcare Market Access Technology Platforms

Retrieved on: 
onsdag, januari 3, 2024
Biotechnology, Pharmaceutical, Optical, Medical Supplies, Health, Health Technology, Clinical Trials, Other Health, DED, EHR, SFA, BID, Physician, ECP, Telecanthus, Insurance, Patient, Penn Entertainment, PAS, Pharmaceutical industry

Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced that it has partnered with three leading healthcare technology platforms to expand U.S. availability of VEVYE® (cyclosporine ophthalmic solution) 0.1%, a patented, non‑preserved, twice-daily (BID) dosed, ophthalmic solution prescription drug based on a “water-free” semifluorinated alkane (SFA) eyedrop technology.

Key Points: 
  • Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced that it has partnered with three leading healthcare technology platforms to expand U.S. availability of VEVYE® (cyclosporine ophthalmic solution) 0.1%, a patented, non‑preserved, twice-daily (BID) dosed, ophthalmic solution prescription drug based on a “water-free” semifluorinated alkane (SFA) eyedrop technology.
  • Harrow’s three market access partnerships for VEVYE include:
    PhilRx is an innovative patient access platform that provides end-to-end visibility into the entire prescription life cycle, starting when the eyecare professional (ECP) writes a VEVYE prescription electronically to PhilRx directly from their electronic health record (EHR).
  • Apollo Care is a comprehensive program designed to establish and manage copay program deployment, optimizing patient access and affordability of VEVYE.
  • In commenting on the announcement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “Harrow was founded on a commitment to patient access.

AXIM® Biotechnologies Partners With Leading Diagnostic Manufacturer Auer Precision to Scale Assay Production

Retrieved on: 
onsdag, december 20, 2023
DED, Partnership, Research, FDA, Disease, SAN, Telecanthus, OTCQB, Immunoglobulin E, Patient, Auer, Pharmaceutical industry

SAN DIEGO, CA, Dec. 20, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire –AXIM Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare diagnostic solutions development company, announced today that the Company has signed an agreement with contract manufacturer Auer Precision for the production of its two FDA-cleared diagnostic assays designed for point-of-care diagnosis of Dry Eye Disease (DED). The partnership will enable scaling of production quantities of the assays to meet demand for the tests in a cost-effective way.

Key Points: 
  • The partnership will enable scaling of production quantities of the assays to meet demand for the tests in a cost-effective way.
  • Until this agreement, the Company has been manufacturing both its ocular T-POC TOTAL IgE Immunoassay and T-POC LACTOFERRIN Immunoassay FDA-cleared Kits in-house.
  • Through the agreement Auer will begin producing both tests as soon as possible to meet the demand of clinicians nationwide as well as scale production as necessary in the coming months.
  • They were quick to prove their understanding of our tests and firm in their ability to scale production to meet our needs now and in the future.

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

Retrieved on: 
torsdag, 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.

OKYO Pharma Announces Last Patient Enrolled in OK-101 Phase 2 Clinical Trial to Treat Dry Eye Disease Has Completed Final Protocol Visit

Retrieved on: 
måndag, december 4, 2023
DED, Tears, FDA, Data analysis, Clinical trial, Feedback, CSO, Patient, Pharmaceutical industry

In addition, data analysis plans for the trial have now been finalized and submitted to FDA for feedback, in anticipation of database lock, subsequent data analysis, and reporting of top-line findings on OK-101.

Key Points: 
  • In addition, data analysis plans for the trial have now been finalized and submitted to FDA for feedback, in anticipation of database lock, subsequent data analysis, and reporting of top-line findings on OK-101.
  • “With the final patient visit now completed in the phase 2 DED trial, we remain on track with the release of top-line results in December of this year,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma.
  • This condition affects approximately 49 million people in the United States alone and has been difficult to positively diagnose and treat due to the multifactorial nature of the condition.
  • Several contributing factors can lead to this condition, including age, sex, certain medical conditions, reduced tear production and tear film dysfunction.

Nordic Pharma Group B.V. Through Its Subsidiary Amring Pharmaceuticals Inc., Completes Acquisition of Visant Medical to Launch Novel Therapy for Dry Eye Disease in the United States

Retrieved on: 
måndag, december 18, 2023
Medical Devices, Health, Clinical Trials, Pharmaceutical, Optical, Biotechnology, DED, University of Pikeville, OD, FDA, Acquisition, Drainage, Optometry, Professional corporation, MD, University, Associate professor, P.C, Telecanthus, CPT, Patient, Hyaluronic acid, Pharmaceutical industry

Amring Pharmaceuticals Inc. (Amring), a subsidiary of Nordic Group B.V. (Nordic Pharma), announced today the completion of its acquisition of Visant Medical, Inc. (Visant), a leader in medical technology innovation in Dry Eye Disease (DED).

Key Points: 
  • Amring Pharmaceuticals Inc. (Amring), a subsidiary of Nordic Group B.V. (Nordic Pharma), announced today the completion of its acquisition of Visant Medical, Inc. (Visant), a leader in medical technology innovation in Dry Eye Disease (DED).
  • Nordic Pharma will launch and commercialize LACRIFILL in the U.S. and has been chosen because of its focus on Ophthalmology.
  • This acquisition will enhance Nordic Pharma’s impact on the global ophthalmology market starting with the U.S. launch of LACRIFILL, the patented therapy for DED.
  • “Visant is thrilled to be joining the Nordic Pharma group,” said Vartan Ghazarossian, Ph.D., Visant co-founder and CEO.

Oculis Reports Q3 2023 Financial Results and Provides Company Update

Retrieved on: 
onsdag, 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.

ArcelorMittal S.A.: ArcelorMittal enters the additive manufacturing industry as a steel powder supplier

Retrieved on: 
onsdag, november 15, 2023
H13, ADM, Research, DED, 316L, Powder, National Digital Research Centre, Steel, Scaled Composites Tier One, ArcelorMittal, Digital, Development, JV, Growth, Electricity, Corrosion, LPBF, H11, 3D printing, Renewable energy, Online shopping, M300

ArcelorMittal today announces its entry into the additive manufacturing (AdM) market as a steel powder supplier.

Key Points: 
  • ArcelorMittal today announces its entry into the additive manufacturing (AdM) market as a steel powder supplier.
  • This will enable ArcelorMittal to supply significant volumes of steel powders with consistent quality, reliability and traceability, meeting the high standards and specifications of the AdM industry.
  • In line with ArcelorMittal's commitment to sustainability and decarbonisation, the company is committed to advancing the sustainability of additive manufacturing.
  • By producing and supplying steel powders for additive manufacturing, we are expanding our portfolio of advanced materials and solutions for the future of manufacturing.

TearSolutions, Inc. Appoints Robert Dempsey to its Board of Directors

Retrieved on: 
onsdag, november 1, 2023
FDA, Therapy, Takeda, Telecanthus, Drug development, DED, Safety, Patient, Shire, Pharmaceutical industry, Ophthalmology, Novartis

CHARLOTTESVILLE, Va., Nov. 01, 2023 (GLOBE NEWSWIRE) -- TearSolutions, Inc. , a privately held biotech company developing potentially disruptive therapies for the treatment of Dry Eye Disease (DED) and other ocular surface related diseases, today announced that Robert Dempsey has been appointed to the Company’s Board of Directors.

Key Points: 
  • CHARLOTTESVILLE, Va., Nov. 01, 2023 (GLOBE NEWSWIRE) -- TearSolutions, Inc. , a privately held biotech company developing potentially disruptive therapies for the treatment of Dry Eye Disease (DED) and other ocular surface related diseases, today announced that Robert Dempsey has been appointed to the Company’s Board of Directors.
  • “Robert is a proven industry leader with extensive and highly relevant experience in Ophthalmology and DED,” said Anil Asrani, President and CEO of TearSolutions.
  • His widespread experience in Ophthalmology stems from diverse leadership roles across commercial, business development, medical affairs, and venture-backed startups.
  • Currently, Robert serves as the Chief Executive Officer at AsclepiX Therapeutics focused on advancing an integrin regulating peptide for posterior segment diseases.