Acanthamoeba keratitis

Contact Lens Solutions Market size to grow by USD 540.94 million from 2023 to 2028, Increased preference for contact lenses over spectacles to boost the market- Technavio

Retrieved on: 
Tuesday, January 9, 2024
Online, Hydrogen, Contact, Marketing, Risk, Sale, Near-sightedness, Paratriathlon, Health, Multi, Approximation error, Incidence, Supermarket, Novartis, USD, Bausch, Walmart, Growth, Pharmacy, Acanthamoeba keratitis, Distribution, HTTP

NEW YORK, Jan. 8, 2024 /PRNewswire/ -- The contact lens solutions market is estimated to grow by USD 540.94 million from 2023 to 2028, according to Technavio.

Key Points: 
  • NEW YORK, Jan. 8, 2024 /PRNewswire/ -- The contact lens solutions market is estimated to grow by USD 540.94 million from 2023 to 2028, according to Technavio.
  • The North American contact lens solutions market has experienced consistent growth, attributed to widespread product usage, availability, and the presence of established suppliers.
  • The Contact Lens Solutions Market showcases steady growth due to increased demand for corrective vision aids like Novartis and Bausch & Lomb's offerings.
  • The contact lenses market size is estimated to grow at a CAGR of 5.58% between 2022 and 2027.

SIFI ANNOUNCES LICENSE AGREEMENT WITH AVANZANITE BIOSCIENCE FOR AKANTIOR®

Retrieved on: 
Tuesday, January 10, 2023
Partnership, Food, European Medicines Agency, Country, Acanthamoeba keratitis, Ophthalmology, European Directive on Traditional Herbal Medicinal Products, EAP, Patient, American Academy, Committee, US Foods, Market Access Program, Investment, FDA, MAA, European Economic Area, EMA, Pharmaceutical industry, Renewable energy

SIFI will focus its European market access and commercial activities on existing markets, and the new markets Germany and the United Kingdom.

Key Points: 
  • SIFI will focus its European market access and commercial activities on existing markets, and the new markets Germany and the United Kingdom.
  • CATANIA, Italy, Jan. 10, 2023 /PRNewswire/ -- SIFI, a leading international ophthalmic company headquartered in Italy, today announced that it has partnered with Avanzanite Bioscience (Avanzanite), a Dutch specialty pharmaceutical company, to exclusively commercialize and distribute AKANTIOR® (polihexanide) in 26 Countries within the European Economic Area and Switzerland.
  • Under the terms of the agreement, SIFI will handle all ongoing regulatory activities, whilst Avanzanite will focus on market access, distribution and commercial activities in those markets.
  • SIFI and Avanzanite also agreed to expand the Early Access Program (EAP) already in place for the big 5 European Countries to selected Countries within the scope of the license to Avanzanite.

Avanzanite Bioscience Launches Novel Business Model to Commercialize Innovative Medicines for Rare Diseases in Europe

Retrieved on: 
Tuesday, November 15, 2022
Science, Other Philanthropy, Biotechnology, Research, Pharmaceutical, Health, Philanthropy, Clinical Trials, Marketing, Teva Pharmaceuticals, Partnership, Entrepreneurship, Multimedia, European Medicines Agency, Research, Alnylam Pharmaceuticals, Acanthamoeba keratitis, European Economic Area, Growth, Severe cognitive impairment, Advisory board, Patient, Pharmaceutical industry, EU, ProQR

Today, Avanzanite Bioscience B.V. (Avanzanite or the Company) officially launches its commercial-stage enterprise, seeking to expand patient access to medicines for rare diseases in Europe while unlocking revenue and growth potential for emerging research-based biopharmaceutical originators.

Key Points: 
  • Today, Avanzanite Bioscience B.V. (Avanzanite or the Company) officially launches its commercial-stage enterprise, seeking to expand patient access to medicines for rare diseases in Europe while unlocking revenue and growth potential for emerging research-based biopharmaceutical originators.
  • Avanzanite, a fully authorized distributor of medicinal products, partners with these biopharmaceutical collaborators through flexible, bespoke licensing and distribution partnerships across Europe.
  • The Companys novel business model enables the global commercialization of promising medicines and addresses the unsustainable inequities in access to innovative orphan drugs across Europe.
  • Equally important, the Company's humanitarian goal stems from our commitment to enabling access to novel medicines for patients who suffer from orphan diseases regardless of where in Europe they live.

SIFI ANNOUNCES EMA VALIDATION OF ITS MARKETING AUTHORISATION APPLICATION FOR AKANTIOR® FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS AND THE OPENING OF AN EARLY ACCESS PROGRAM

Retrieved on: 
Tuesday, June 7, 2022
Severe cognitive impairment, Marketing, Leadership, Eye, Company, Acanthamoeba keratitis, Research, EMA, EC, UCL Institute of Ophthalmology, Standard of care, Transplant, University College London, Disease, CEO, Committee, European Directive on Traditional Herbal Medicinal Products, Partnership, Trophozoite, CHMP, Medicines and Healthcare products Regulatory Agency, Patient, Fungal keratitis, SIFI, EAPS, Committee for Medicinal Products for Human Use, Polyhexanide, Phase, Medication, Incidence, Quality of life, European Medicines Agency, Royal commission, European Commission, Drug development, West Pharmaceutical Services, Marketing Authorisation Application, Institute, AK, Cyst, Medical device, Pharmaceutical industry, Acanthamoeba, Ophthalmology

"We are incredibly pleased to be working in partnership with SIFI on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division.

Key Points: 
  • "We are incredibly pleased to be working in partnership with SIFI on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division.
  • "We look forward to helping facilitate broader access to polihexanide for patients with critical unmet medical needs suffering from acanthamoeba keratitis."
  • AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.
  • Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA Orphan Drug Designation.

SIFI ANNOUNCES EMA VALIDATION OF ITS MARKETING AUTHORISATION APPLICATION FOR AKANTIOR® FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS AND THE OPENING OF AN EARLY ACCESS PROGRAM

Retrieved on: 
Tuesday, June 7, 2022
Severe cognitive impairment, Marketing, Leadership, Eye, Company, Acanthamoeba keratitis, Research, EMA, EC, UCL Institute of Ophthalmology, Standard of care, Transplant, University College London, Disease, CEO, Committee, European Directive on Traditional Herbal Medicinal Products, Partnership, Trophozoite, CHMP, Medicines and Healthcare products Regulatory Agency, Patient, Fungal keratitis, SIFI, EAPS, Committee for Medicinal Products for Human Use, Polyhexanide, Phase, Medication, Incidence, Quality of life, European Medicines Agency, Royal commission, European Commission, Drug development, West Pharmaceutical Services, Marketing Authorisation Application, Institute, AK, Cyst, Medical device, Pharmaceutical industry, Acanthamoeba, Ophthalmology

"We are incredibly pleased to be working in partnership with SIFI on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division.

Key Points: 
  • "We are incredibly pleased to be working in partnership with SIFI on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division.
  • "We look forward to helping facilitate broader access to polihexanide for patients with critical unmet medical needs suffering from acanthamoeba keratitis."
  • AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.
  • Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA Orphan Drug Designation.

SIFI RECEIVES FAVORABLE FEEDBACK FROM THE US FDA ON AKANTIOR® FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS

Retrieved on: 
Monday, May 16, 2022
Company, Disease, Polyhexanide, Acanthamoeba keratitis, Eye, Incidence, NCE, Cyst, Patient, Quality of life, Severe cognitive impairment, SIFI, Research, Patent, FDA, Trophozoite, Massachusetts Eye and Ear, Transplant, University, Orphan, NDA, American Journal, Illinois Eye and Ear Infirmary, AK, The Company, Ophthalmology, MD, Fungal keratitis, CEO, Pharmaceutical industry, Acanthamoeba, New chemical entity

ABOUT AKANTIOR: AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.

Key Points: 
  • ABOUT AKANTIOR: AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.
  • Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA Orphan Drug Designation.
  • ABOUT Acanthamoeba Keratitis (AK): AK is a rare, acute, severe parasitic corneal infection caused by Acanthamoeba, a free-living amoeba.
  • ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, focusing on eye care since 1935.

SIFI RECEIVES FAVORABLE FEEDBACK FROM THE US FDA ON AKANTIOR® FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS

Retrieved on: 
Monday, May 16, 2022
Company, Disease, Polyhexanide, Acanthamoeba keratitis, Eye, Incidence, NCE, Cyst, Patient, Quality of life, Severe cognitive impairment, SIFI, Research, Patent, FDA, Trophozoite, Massachusetts Eye and Ear, Transplant, University, Orphan, NDA, American Journal, Illinois Eye and Ear Infirmary, AK, The Company, Ophthalmology, MD, Fungal keratitis, CEO, Pharmaceutical industry, Acanthamoeba, New chemical entity

ABOUT AKANTIOR: AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.

Key Points: 
  • ABOUT AKANTIOR: AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.
  • Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA Orphan Drug Designation.
  • ABOUT Acanthamoeba Keratitis (AK): AK is a rare, acute, severe parasitic corneal infection caused by Acanthamoeba, a free-living amoeba.
  • ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, focusing on eye care since 1935.

SIFI Announces the Granting of a Second FDA Orphan Drug Designation for Polihexanide in Fungal Keratitis

Retrieved on: 
Monday, March 14, 2022
University, Acanthamoeba keratitis, Incidence, Fungal keratitis, Mazzone, Business, Risk, Company, III, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Quality of life, Person, EMA, Severe cognitive impairment, DNA, PDUFA, Patient, Marketing, European Medicines Agency, SIFI, Infection, Disease, Food, ODD, Program, Diagnosis, Pharmaceutical industry, Ophthalmology, Lancet

According to The Lancet , annual global incidence of fungal keratitis is estimated at 1,051,787 cases, with the highest rates in Asia and Latin America.

Key Points: 
  • According to The Lancet , annual global incidence of fungal keratitis is estimated at 1,051,787 cases, with the highest rates in Asia and Latin America.
  • In the U.S., an estimated 15,660 patients annually most of whom are contact lens wearers or agricultural workers are diagnosed with fungal keratitis.
  • Only one drug is currently approved for fungal keratitis in the U.S., and around one in three patients fail on the treatment.
  • Brown L., Leck AK, Gichangi M, Burton MJ, Denning DW, The global incidence and diagnosis of fungal keratitis.

SIFI Announces the Granting of a Second FDA Orphan Drug Designation for Polihexanide in Fungal Keratitis

Retrieved on: 
Monday, March 14, 2022
University, Acanthamoeba keratitis, Incidence, Fungal keratitis, Mazzone, Business, Risk, Company, III, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Quality of life, Person, EMA, Severe cognitive impairment, DNA, PDUFA, Patient, Marketing, European Medicines Agency, SIFI, Infection, Disease, Food, ODD, Program, Diagnosis, Vaccine, Pharmaceutical industry, Ophthalmology, Lancet

CATANIA, Italy, March 14, 2022 /PRNewswire/ -- SIFI S.p.A. ("SIFI" or the "Company"), a leading international ophthalmic pharmaceutical company, announced today that the U.S. Food and Drug Administration ("FDA") has approved the company's Orphan Drug Designation ("ODD") application for its investigational anti-infective polymer polihexanide for the treatment of fungal keratitis. This is a second orphan ophthalmic indication for the polihexanide Research & Development program. 

Key Points: 
  • CATANIA, Italy, March 14, 2022 /PRNewswire/ -- SIFI S.p.A. ("SIFI" or the "Company"), a leading international ophthalmic pharmaceutical company, announced today that the U.S. Food and Drug Administration ("FDA") has approved the company's Orphan Drug Designation ("ODD") application for its investigational anti-infective polymer polihexanide for the treatment of fungal keratitis.
  • This is a second orphan ophthalmic indication for the polihexanide Research & Development program.
  • Only one drug is currently approved for fungal keratitis in the U.S., and around one in three patients fail on the treatment.
  • Brown L., Leck AK, Gichangi M, Burton MJ, Denning DW, The global incidence and diagnosis of fungal keratitis.

SIFI Announces Positive Topline Results of the Pivotal Phase III Study of Polihexanide for the Treatment of Acanthamoeba Keratitis

Retrieved on: 
Tuesday, October 19, 2021
Marketing, Caregiver, European Directive on Traditional Herbal Medicinal Products, University College London, Adequate Yearly Progress, Acanthamoeba keratitis, Institute, AK, Trophozoite, Transplant, Patient, European Medicines Agency, MAA, Incidence, EMA, SIFI, Disease, III, UCL Institute of Ophthalmology, FDA, Quality of life, CEO, Medicine, Phase, Severe cognitive impairment, Cyst, Food, Physician, Safety, Pharmaceutical industry

CATANIA, Italy, Oct. 19, 2021 /PRNewswire/ -- SIFI, a leading international ophthalmic company, announced today that the pivotal Phase III study on polihexanide 0,08% monotherapy in adults and adolescents with Acanthamoeba keratitis (AK), met its primary endpoint of 'clinical resolution rate over a 12-month timeframe'. It also demonstrated an encouraging safety and tolerability profile. Based on these results, SIFI will request an accelerated assessment and plans to file a Marketing Authorisation Application (MAA) at the European Medicines Agency (EMA) for polihexanide 0,08% monotherapy under the Centralised Procedure for Orphan-Designated Medicinal Products in the first half of 2022.

Key Points: 
  • - Polihexanide would become the first approved drug for the treatment of Acanthamoeba Keratitis, a rare, sight-threatening parasitic eye infection.
  • With these trial results, polihexanide could become the first approved drug for the treatment of AK anywhere in the world.
  • The Phase III data give us clarity that monotherapy with polihexanide 0,08% will effectively address this unmet medical need.
  • Both treatment arms have used a novel standardized treatment protocol It is the first-ever Phase III study for an investigational medicine performed for AK.