Allergic conjunctivitis

Orphan designation: Tranilast Prevention of scarring post glaucoma filtration surgery, 27/07/2010 Positive

Retrieved on: 
Thursday, April 18, 2024
Eurostat, Diagnosis, Civil service commission, Optic nerve, Brain, Pressure, Cell, Disease, Risk, Patient, Committee, Knowledge, Regulation, Cancer, EMA, IRIS, Scar, Eye, Wound healing, European, Allergic conjunctivitis, COMP, Collagen, Skin, European Commission, Safety, Glaucoma, Sclera, Pharmaceutical industry

Orphan designation: Tranilast Prevention of scarring post glaucoma filtration surgery, 27/07/2010 Positive

Key Points: 


Orphan designation: Tranilast Prevention of scarring post glaucoma filtration surgery, 27/07/2010 Positive

Nicox Updates on Corporate, Pipeline and Financing Perspectives and Will Hold a Webcast on March 18, 2024

Retrieved on: 
Wednesday, March 13, 2024
Mont Blanc, IOP, OCT, Whistler, Glaucoma, Ocular hypertension, Fluticasone, Database, Intraocular pressure, NCX, COVID-19, Patient, NDA, BlackRock, Sale, Bausch & Lomb, Therapy, Retina, Allergic conjunctivitis, Safety, Patent, Telecanthus, FDA, Corporation, Food, Pharmaceutical industry

“Nicox is focusing its resources on the Denali Phase 3 pivotal trial of its lead asset NCX 470 in glaucoma.

Key Points: 
  • “Nicox is focusing its resources on the Denali Phase 3 pivotal trial of its lead asset NCX 470 in glaucoma.
  • We are reducing costs, including the size of the organization, and are exploring advancing NCX 1728, through collaborations.
  • In January 2024, Nicox expanded the territory of the exclusive licensing agreement with Harrow, Inc., to include Canada.
  • The Company is financed to at least November 2024, based on focusing exclusively on the development of NCX 470.

Global Allergy Conjunctivitis Market Projected to Reach $3.2 Billion by 2028, Driven by Increasing Allergies and Technological Innovations - Long-term Forecast to 2032 - ResearchAndMarkets.com

Retrieved on: 
Friday, April 5, 2024
Health, Optical, Patient, Allergy, Research, Growth, Prevalence, Allergic conjunctivitis, Pollutant, Allergen

The global allergy conjunctivitis market is set to grow from $2.4 billion in 2023 to an estimated $3.2 billion in 2028, demonstrating a robust compound annual growth rate (CAGR) of 5.9%.

Key Points: 
  • The global allergy conjunctivitis market is set to grow from $2.4 billion in 2023 to an estimated $3.2 billion in 2028, demonstrating a robust compound annual growth rate (CAGR) of 5.9%.
  • This growth is fueled by a rise in the global burden of allergies, advancements in personalized medicine, and an expanding elderly population.
  • Innovation in biotechnological research and wider healthcare access in developing regions also contribute to the market's upward trajectory.
  • This noteworthy expansion of the allergy conjunctivitis market reflects a concentrated effort to meet the healthcare needs of those suffering from ocular allergies.

Telios Pharma Announces Successful Phase 2 Results for TL-925, a Novel Treatment for Dry Eye Disease

Retrieved on: 
Wednesday, March 6, 2024
Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, BTK, Senior, ARVO, Research, MD, Inflammation, Pathology, Telecanthus, Pharma, Allergic conjunctivitis, Annual general meeting, Safety, DED, Patient, AC, Pharmaceutical industry

TL-925 was safe and well tolerated and the intention-to-treat analysis demonstrated clinically meaningful and statistically significant efficacy relative to vehicle control across multiple signs and symptoms.

Key Points: 
  • TL-925 was safe and well tolerated and the intention-to-treat analysis demonstrated clinically meaningful and statistically significant efficacy relative to vehicle control across multiple signs and symptoms.
  • “The results are among the most impressive that I have seen in my years working on dry eye clinical development programs.
  • TL-925 is a promising and much needed novel approach for the treatment of DED.”
    A Phase 2b study of TL-925 in DED has been initiated based on these results and is currently enrolling patients.
  • It is increasingly apparent that TL-925 may represent a significant leap forward for the effective treatment of DED and AC.”

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

Retrieved on: 
Thursday, February 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.

Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Dry Eye Disease

Retrieved on: 
Monday, November 27, 2023
Biotechnology, FDA, Optical, Health, NDA, Allergic conjunctivitis, Safety, Food, Inflammation, Telecanthus, Therapy, Type, New Drug Application, Clinical trial, Patient, SPA, Symantec Endpoint Protection, Letter, Pharmaceutical industry

Per draft FDA dry eye disease guidance, efficacy in dry eye disease may be demonstrated with two symptom trials and two sign trials.

Key Points: 
  • Per draft FDA dry eye disease guidance, efficacy in dry eye disease may be demonstrated with two symptom trials and two sign trials.
  • Among other clinical trials, Aldeyra previously conducted two trials for ocular redness (a dry eye disease sign) as well as a dry eye disease symptom trial.
  • The SPA review cycle is anticipated to be 45 days, and Aldeyra expects FDA feedback from the SPA in December of 2023.
  • After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

Almirall Receives European Commission Approval of EBGLYSS® (lebrikizumab) for Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Friday, November 17, 2023
Health, Other Health, Other Science, General Health, Science, Pharmaceutical, Biotechnology, Allergic conjunctivitis, Itch, Adolescence, ALM, Adherence, Safety, Hope, European Commission, Advocate, Disease, Teaching hospital, Civil service commission, TCS, Patient, Week, Doctor of Philosophy, Conjunctivitis, Atopic dermatitis, BME, Eli Lilly and Company, MD, Skin, Almirall, Human, Pharmaceutical industry, Vaccine, Dermatology

“The arrival of novel biologic treatments is marking a new paradigm in the management of atopic dermatitis.

Key Points: 
  • “The arrival of novel biologic treatments is marking a new paradigm in the management of atopic dermatitis.
  • The approval of lebrikizumab represents a leap forward in our ability to provide patients with an effective therapeutic option with demonstrated safety profile.
  • Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe.
  • Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe atopic dermatitis in additional European markets, including the United Kingdom and Switzerland.

Human medicines European public assessment report (EPAR): Ebglyss, Lebrikizumab, Date of authorisation: 16/11/2023, Status: Authorised

Retrieved on: 
Monday, December 18, 2023
People, Eye, Allergic conjunctivitis, Select, Anatomy, ATC, Safety, European Medicines Agency, Ageing, International, IGA, INN, Disease, Language, Overview, Dry, Patient, IIA, Thigh, Conjunctivitis, Marketing, EASI, Atopic dermatitis, Medical Subject Headings, Diagnosis, Red, Skin, Human, Inflammation, Instrumentation, Medicinal plants, Medical device, Copper, Vaccine, Medical imaging, Online shopping, Bookkeeping, Dermatitis, Medicine

Human medicines European public assessment report (EPAR): Ebglyss, Lebrikizumab, Date of authorisation: 16/11/2023, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Ebglyss, Lebrikizumab, Date of authorisation: 16/11/2023, Status: Authorised

Ocular Therapeutix™ Provides Third Quarter 2023 Financial Results and Corporate Update

Retrieved on: 
Tuesday, November 7, 2023
FDA, Research, Growth, ASC, Axitinib, ASCRS, Food, Intraocular pressure, SOL, Medicare, Eye, Telecanthus, Abdominal ultrasonography, OHT, AMD, OAG, Overalls, CPT, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Inflammation, Patient, OPPS, Interest, Allergic conjunctivitis, Clinical trial, Marketing, Webcast, Barings LLC, Macular degeneration, Depreciation, Safety, SPA, Visual acuity, Trial of the century, Pain, Centers for Medicare & Medicaid Services, CMS, Pharmaceutical industry, Beauty salon, Fine chemical, Medical device, Birth control, Video game

BEDFORD, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today reported financial results for the third quarter ended September 30, 2023, and provided updates on its ophthalmology pipeline.

Key Points: 
  • “We made significant progress at Ocular Therapeutix in the third quarter,” said Antony Mattessich, President and CEO.
  • The Company also recorded gains and losses from debt extinguishment, net, of $14.2 million in the third quarter of 2023.
  • Non-cash charges for stock-based compensation and depreciation and amortization were $5.4 million in the third quarter of 2023 versus $4.7 million for the comparable quarter in 2022.
  • Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 4:30 pm Eastern Time to review the Company's financial results and provide a general business update.

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

Retrieved on: 
Tuesday, October 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.