Difluprednate

Adverum Biotechnologies Completes IND Amendment and Prepares to Initiate the Phase 2 LUNA Trial of ADVM-022 in Wet AMD

Retrieved on: 
среда, июля 6, 2022
VEGF, Review, FDA, OPTIC, Injection, Patient, European Medicines Agency, University of Nevada, Reno School of Medicine, Macular degeneration, Research, NAMD, University of Nevada, Reno, Severe cognitive impairment, M.A, GLOBE, AAV, Difluprednate, Retina, Union, U.S. Securities and Exchange Commission, Inflammation, Compliance, Prevalence, World, Â, Food, State, Neovascularization, IND, Private Securities Litigation Reform Act, Heel, Technology, University, Standard of care, Nasdaq, SEC, Incidence, AMD, NASDAQ, Safety, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, LUNA, IVT, Pharmaceutical industry, Adverum Biotechnologies

REDWOOD CITY, Calif., July 06, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that it has completed its Investigational New Drug (IND) amendment with the U.S. Food and Drug Administration (FDA) and is preparing to initiate the Phase 2 LUNA trial of ADVM-022, a single intravitreal (IVT) injection for wet age-related macular degeneration (wet AMD). The World Health Organization’s Review Council and the U.S. Adopted Names Council has adopted the name ixoberogene soroparvovec (Ixo-vec) for ADVM-022 as the international nonproprietary name.

Key Points: 
  • We amended our IND and are on track to dose the first patient in the Phase 2 LUNA trial for the treatment of wet AMD in the coming months.
  • We are excited to initiate our Phase 2 LUNA trial this quarter.
  • The LUNA trial is a multicenter, double-masked, randomized, parallel-group Phase 2 trial evaluating two doses of Ixo-vec, including the 2x10^11 vg/eye dose and a new, lower 6x10^10 vg/eye dose, in wet AMD.
  • Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD, affecting approximately 10% of patients living with AMD.

Cipla receives final approval for generic version of Novartis Pharmaceuticals Corporation Durezol® (Difluprednate Ophthalmic Emulsion 0.05%)

Retrieved on: 
четверг, августа 12, 2021
HIV/AIDS, Difluprednate, HIV, BSE, LinkedIn, CNS, Pain, Urology, Development, IMS Health, Inflammation, ANDA, US FDA, Cardiology, IMS, Movement, Twitter, NSE, Patient, Novartis, Generic drug, Pharmaceutical industry

Cipla's Difluprednate Ophthalmic Emulsion 0.05% is AB-rated generic therapeutic equivalent version of Novartis Pharmaceuticals Corporation's Durezol.

Key Points: 
  • Cipla's Difluprednate Ophthalmic Emulsion 0.05% is AB-rated generic therapeutic equivalent version of Novartis Pharmaceuticals Corporation's Durezol.
  • It is used for the following:
    Treatment of inflammation and pain associated with ocular surgery.
  • According to IQVIA (IMS Health), Durezol had US sales of approximately $106mn for the 12-month period ending June 2021.
  • Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets.

Ocular Therapeutix™ Announces Upcoming Presentation of Interim OTX-TKI Phase 1 Clinical Trial Data at Angiogenesis, Exudation, and Degeneration 2021 – Virtual Edition

Retrieved on: 
пятница, февраля 12, 2021
Health, Medical devices, Surgery, Clinical trials, Pharmaceutical, Optical, Biotechnology, Clinical medicine, Syndromes, Medical specialties, Health, Salivary gland pathology, Sjögren syndrome, Difluprednate

We are particularly encouraged with the interim data presented to date from the Phase 1 trial.

Key Points: 
  • We are particularly encouraged with the interim data presented to date from the Phase 1 trial.
  • The presentation can be accessed February 13th on the Events and Presentations section of the Ocular Therapeutix website.
  • Ocular Therapeutixs first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial.

Ocular Therapeutix Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
вторник, октября 6, 2020
Health, Other Health, Research, Science, Pharmaceutical, Optical, Biotechnology, Medical specialties, Immunology, Clinical medicine, RTT, Allergic conjunctivitis, Allergology, Conjunctivitis, Corticosteroids, ISTA Pharmaceuticals, Chloroarenes, Difluprednate

The award was made outside Oculars 2014 Stock Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The award was made outside Oculars 2014 Stock Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The grant was approved by the Compensation Committee and each of the independent directors of Ocular Therapeutix and was made as an inducement material to his acceptance of employment with Ocular in accordance with Nasdaq Listing Rule 5635(c)(4).
  • Ocular Therapeutixs first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis.

Ocular Therapeutix™ Announces First Patient Dosed in Phase 3 Clinical Trial of DEXTENZA® for the Treatment of Post-Surgical Ocular Inflammation and Pain in Children

Retrieved on: 
четверг, сентября 10, 2020
Research, FDA, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Health, Optical, Science, Other Science, Health, Medicine, Clinical research, Drug discovery, Pharmaceutical industry, Clinical trial, Design of experiments, Allergic conjunctivitis, Difluprednate, Brimonidine/timolol, DEXTENZA, Ocular Therapeutix, Inc.

The Phase 3 clinical trial is a U.S.-based, randomized, multicenter clinical trial that intends to enroll approximately 60 subjects between the ages of 0-3 years.

Key Points: 
  • The Phase 3 clinical trial is a U.S.-based, randomized, multicenter clinical trial that intends to enroll approximately 60 subjects between the ages of 0-3 years.
  • The safety of DEXTENZA was assessed in three Phase 3 clinical trials and a Phase 2 clinical trial.
  • Ocular Therapeutixs first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis.

Ocular Therapeutix™ Announces Successful Resolution of FDA Warning Letter Related to ReSure® Sealant

Retrieved on: 
вторник, сентября 8, 2020
Biotechnology, FDA, Optical, Health, Medical specialties, Immunology, Clinical medicine, Allergic conjunctivitis, Allergology, Conjunctivitis, Corticosteroids, ISTA Pharmaceuticals, Difluprednate, ReSure® Sealant, Ocular Therapeutix, Inc.

The violation cited in Warning Letter (CMS #564663) has been addressed and Ocular is committed to sustained compliance with all federal regulations.

Key Points: 
  • The violation cited in Warning Letter (CMS #564663) has been addressed and Ocular is committed to sustained compliance with all federal regulations.
  • This resolution gives us the confidence to begin active promotion of ReSure and realize the synergies of a two-product field force.
  • Ocular Therapeutixs first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis.

Ocular Therapeutix Announces Third Medicare Administrative Contractor to Establish New Published Physician Fee Schedule for Administration of Intracanalicular Inserts

Retrieved on: 
пятница, сентября 4, 2020
Biotechnology, FDA, Managed care, Health, Pharmaceutical, Optical, Other Science, Research, Surgery, Science, Clinical trials, Medical specialties, Immunology, Clinical medicine, RTT, Allergic conjunctivitis, Allergology, Conjunctivitis, ISTA Pharmaceuticals, Difluprednate, DEXTENZA, Ocular Therapeutix, Inc.

The professional fee for CPT code 0356T is now eligible to be paid per the established local fee schedule, which can be found on the NGS website.

Key Points: 
  • The professional fee for CPT code 0356T is now eligible to be paid per the established local fee schedule, which can be found on the NGS website.
  • Combined, the three MACs with published fee schedules consisting of NGS, First Coast and Novitas Solutions cover approximately 50% of all Medicare beneficiaries.
  • Ocular Therapeutixs first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis.

Ocular Therapeutix Announces Its First Published Physician Fee Schedule for Administration of Intracanalicular Inserts

Retrieved on: 
среда, июля 15, 2020
Health, Surgery, Practice Management, Clinical trials, Pharmaceutical, Optical, Biotechnology, Medical specialties, Medicine, Immunology, Aflibercept, Bayer AG, Breakthrough therapy, Sanofi, Allergic conjunctivitis, Regeneron Pharmaceuticals, Conjunctivitis, ISTA Pharmaceuticals, Difluprednate, DEXTENZA, Ocular Therapeutix, Inc.

The professional fee for CPT code 0356T is now eligible to be paid per the established local fee schedule, which can be found on the Novitas website.

Key Points: 
  • The professional fee for CPT code 0356T is now eligible to be paid per the established local fee schedule, which can be found on the Novitas website.
  • Ocular Therapeutixs first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Ocular Therapeutix recently completed a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis.
  • Also, in collaboration with Regeneron, Ocular Therapeutix is currently developing an extended-delivery formulation of aflibercept for the treatment of retinal diseases.

Ocular Therapeutix™ Provides Business Update and Response to COVID-19 Global Pandemic

Retrieved on: 
понедельник, апреля 13, 2020
Research, FDA, Clinical trials, Biotechnology, Other Health, Health, Optical, Other Science, Science, Medical specialties, Immunology, Medicine, Allergic conjunctivitis, Allergology, Conjunctivitis, Corticosteroids, ISTA Pharmaceuticals, Difluprednate, DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg, Ocular Therapeutix, Inc.

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 announced its response to the COVID-19 pandemic and related impact on Ocular Therapeutixs business operations.

Key Points: 
  • 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 announced its response to the COVID-19 pandemic and related impact on Ocular Therapeutixs business operations.
  • As is typical of such early stage trials, visual acuity has not shown consistent improvement across the cohort.
  • Ocular Therapeutixs first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Ocular Therapeutix is conducting a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis.

Ocular Therapeutix Announces Permanent J-Code for DEXTENZA® (dexamethasone ophthalmic insert) Effective October 1, 2019

Retrieved on: 
вторник, октября 1, 2019
Biotechnology, Health, Pharmaceutical, Optical, American Medical Association, Health, Healthcare Common Procedure Coding System, Food and Drug Administration, Organic compounds, Chemical compounds, Nonsteroidal anti-inflammatory drugs, Corticosteroids, Difluprednate, Bromfenac

Under the Healthcare Common Procedure Coding System (HCPCS), the J-code (J1096) will become effective October 1, 2019 and will replace the previously issued C-code for DEXTENZA (C9048), which became effective July 1, 2019.

Key Points: 
  • Under the Healthcare Common Procedure Coding System (HCPCS), the J-code (J1096) will become effective October 1, 2019 and will replace the previously issued C-code for DEXTENZA (C9048), which became effective July 1, 2019.
  • We are pleased that DEXTENZA has received its own permanent product-specific J-Code, said Antony Mattessich, President and Chief Executive Officer.
  • DEXTENZA is an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery.
  • Ocular Therapeutixs first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.