VKC

Harrow Licenses Canadian Rights to Apotex for Five Branded Ophthalmic Pharmaceutical Products

Retrieved on: 
星期四, 二月 15, 2024
Surgery, Medical Supplies, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Optical, Senior, OTC, Telecanthus, Alkane, Allergic conjunctivitis, VKC, Patient, Biosimilar, Vernal keratoconjunctivitis, Partnership

Harrow, Inc. (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, and Apotex Inc. (“Apotex”), Canada’s largest pharmaceutical company, today jointly announced an exclusive out-licensing agreement under which Apotex will market and distribute VERKAZIA® and over-the-counter (OTC) Cationorm® PLUS in the Canadian market, and concurrently, pursue market approval in Canada for VEVYE®, IHEEZO®, and ZERVIATE®.

Key Points: 
  • Harrow, Inc. (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, and Apotex Inc. (“Apotex”), Canada’s largest pharmaceutical company, today jointly announced an exclusive out-licensing agreement under which Apotex will market and distribute VERKAZIA® and over-the-counter (OTC) Cationorm® PLUS in the Canadian market, and concurrently, pursue market approval in Canada for VEVYE®, IHEEZO®, and ZERVIATE®.
  • View the full release here: https://www.businesswire.com/news/home/20240215859659/en/
    “We are pleased to enter the Canadian market through this partnership with Apotex, which has a proven track record of success serving Canadian eyecare professionals and their patients,” said Mark L. Baum, Chairman and Chief Executive Officer of Harrow.
  • And for products, Apotex will pursue approval for in Canada:
    VEVYE (cyclosporine ophthalmic solution) 0.1%, a novel water-free vehicle (perfluorobutylpentane) based on semifluorinated alkanes, indicated to treat the signs and symptoms of dry eye disease.
  • ZERVIATE (cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated for the treatment of ocular itching associated with allergic conjunctivitis.

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

Retrieved on: 
星期二, 十月 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.

Harrow Acquires Santen’s Branded Ophthalmic Portfolio

Retrieved on: 
星期二, 七月 18, 2023
Surgery, Medical Supplies, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Optical, Oaktree Capital Management, Allergy, Cornea, Keratitis, Eye, Ophthalmology, VKC, Optometry, Vernal keratoconjunctivitis, EBITDA, Acquisition, Patient, Risk, Allergic conjunctivitis, Tobramycin, Conjunctivitis, Full, Pharmaceutical industry

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.

Oyster Point Pharma Reports Third Quarter 2022 Financial Results and Recent Business Highlights

Retrieved on: 
星期四, 十一月 10, 2022
IND, Homeostasis, Safety, Research, Risk, First, Development, Ophthalmology, Public relations, Stinger, Tender, Company, Trigeminal nerve, Program, Nach, Letter, Security (finance), Administration, Industry, Marketing, Rest, Throat irritation, Nose, Prescription, SEC, Scratching, U.S. Securities and Exchange Commission, AAV, Science, AKC, User experience, Patient, Money transmitter, Acquisition, Schedule, Tender offer, COVID-19, IgG4-related ophthalmic disease, Protein, Parasympathetic nervous system, Nasdaq, Dry eye syndrome, OP, Eye, Antibody, Product, Nasal spray, Sneeze, Growth, NGF, FDA, GLOBE, Lipid, Cough, ETF, Failure, VKC, DAO, Vernal keratoconjunctivitis, MMS, INT, Signs and symptoms, NK, CVR, Histamine, Duane syndrome, Pharmaceutical industry, Health insurance, Fine chemical, Parent, Income, Varenicline, Viatris

During the third quarter of 2022, the Company also disclosed an additional target and further indications for its ETF gene therapy program.

Key Points: 
  • During the third quarter of 2022, the Company also disclosed an additional target and further indications for its ETF gene therapy program.
  • Cash Position: As of September30, 2022, cash and cash equivalents was $68.8 million, compared to $104.9 million as of June 30, 2022.
  • Oyster Point Pharma is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases.
  • The tender offer for the outstanding common stock of Oyster Point Pharma Inc. (OP) has not yet been commenced.

Global Allergic Conjunctivitis Market Report (2022 to 2027) - Players Include Ocular Therapeutix, Portola Pharmaceuticals and Alcon - ResearchAndMarkets.com

Retrieved on: 
星期二, 五月 31, 2022
Health, Other Health, Giant, GPC, Urbanization, AKC, Population, Allergic conjunctivitis, Incidence, Conjunction (grammar), Patient, OTC, Cetirizine, Transport, COVID-19, OA, Awareness, SAC, PAC, Adoption, VKC, Vernal keratoconjunctivitis, CAGR, Prevalence, Allergen, Niemann–Pick disease, type C, Health insurance, Pharmaceutical industry

Recently, the prevalence of allergic conjunctivitis has increased due to factors like rapid urbanization and an increasing number of allergens.

Key Points: 
  • Recently, the prevalence of allergic conjunctivitis has increased due to factors like rapid urbanization and an increasing number of allergens.
  • United States dominates Global Allergic Conjunctivitis Market, Patients Population & Treated Patients Population
    As per our analysis, the United States stands out as the largest market for allergic conjunctivitis treatments due to the high prevalence of allergic conjunctivitis.
  • Our report covers numerous Disease Type variants like Seasonal Allergic Conjunctivitis (SAC) & Perennial Allergic Conjunctivitis (PAC), Vernal Keratoconjunctivitis (VKC), Atopic Keratoconjunctivitis (AKC), and Giant Papillary Conjunctivitis (GPC).
  • The increase in awareness of allergic conjunctivitis associated with medical treatment & upcoming therapies is enhancing the market expansion.

Santen’s Verkazia® (Cyclosporine Ophthalmic Emulsion) 0.1% Now Available for the Treatment of Vernal Keratoconjunctivitis in Children and Adults in the United States

Retrieved on: 
星期一, 五月 2, 2022
Pharmaceutical, Health, Optical, Cytokine, Immune system, Pain, Inc., Eye, Vernal keratoconjunctivitis, Patient, Founder, Acquisition, OTC, Risk, FDA, Inflammation, Eye injury, Severe cognitive impairment, VKC, Ophthalmology, Quality of life, Uncertainty, Cornea, Tearing, Disease, Mark (given name), Achievement, Allergic inflammation, Cover My Eyes (Pain and Heaven), CEO, Research, Sport, Pharmaceutical industry, Ciclosporin

We are proud to make Verkazia available for all those with VKC in the United States who have lacked optimal treatment options for this condition.

Key Points: 
  • We are proud to make Verkazia available for all those with VKC in the United States who have lacked optimal treatment options for this condition.
  • In addition, having a treatment option for the rare disease VKC will strengthen our existing product portfolio for ocular surface disease in the United States.
  • Worldwide, Verkazia is available for the treatment of VKC in the United States, Canada, and select countries across Asia and Europe.
  • Verkazia (cyclosporine ophthalmic emulsion) 0.1% is indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults.

Akari Therapeutics Announces New Data with Nomacopan from its Surface of the Eye Program

Retrieved on: 
星期一, 十月 25, 2021
Lung, University College London, T helper cell, Dexamethasone, Inflammation, Thrombotic microangiopathy, Failure, UCL, Leukotriene, Drug development, European Medicines Agency, IL-9, UCL Institute of Ophthalmology, Pathology, C5a, EMA, Security (finance), U.S. Securities and Exchange Commission, Patient, Private Securities Litigation Reform Act, FDA, LTB4, Food, SEC, Eye, Risk, University college, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Annual report, Moorfields Eye Hospital, BP, TMA, Steroid, Leukotriene B4, VKC, Biomarker, COVID-19, Program, Vernal keratoconjunctivitis, Nasdaq, MMP, Therapy, Institute, Intellectual property, GLOBE, AKC, HIV disease progression rates, Seasonal adjustment, Pharmaceutical industry, Vaccine, Medical device

The article in Allergy summarizes a large body of work undertaken with University College of London and Moorfields Eye Hospital.

Key Points: 
  • The article in Allergy summarizes a large body of work undertaken with University College of London and Moorfields Eye Hospital.
  • MMP shares a similar pathology with bullous pemphigoid where Akari has initiated a Phase III study with nomacopan.
  • Clive Richardson, Chief Executive Officer of Akari, commented, The new surface of the eye data is an important step forward in our program and highlights the potential benefits of nomacopans differentiated bi-specific mode of action.
  • Taken together with prior data this collectively points to the more severe form of these diseases as important clinical targets for nomacopan within the $6bn+ surface of the eye market.

VerkaziaTM (cyclosporine 0.1%) for the Treatment of Severe Vernal Keratoconjunctivitis is Now Reimbursed by Non-Insured Health Benefits (NIHB) Program

Retrieved on: 
星期二, 八月 17, 2021
Health, Optical, Population, Teva Canada Ltd v Pfizer Canada Inc, Quality of life, Tearing, Ciclosporin, Research, Corneal ulcer, Inflammation, OTC, Vernal keratoconjunctivitis, Patient, Health Canada, Eye, Recurrence, Itch, VKC, Health insurance

Santen is continuing to have discussions with other provinces, territories, and federal agencies regarding the listing of Verkazia under publicly funded drug programs.

Key Points: 
  • Santen is continuing to have discussions with other provinces, territories, and federal agencies regarding the listing of Verkazia under publicly funded drug programs.
  • VKC is a rare and recurrent allergic eye condition, most common in children and adolescents, that causes severe inflammation of the surface of the eye.
  • The treatment should be discontinued if no improvement in signs and symptoms of vernal keratoconjunctivitis is observed.
  • The treatment can be maintained at the recommended dose or decreased to one drop twice daily once adequate control of signs and symptoms is achieved.