Photophobia

Eton Pharmaceuticals Announces Commercial Availability of Ultra-Rare Disease Product Nitisinone Capsules

Retrieved on: 
Friday, February 2, 2024
Partnership, Conjunctivitis, Medicine, Inflammation, Vitamin, Thrombocytopenia, Immune system, Tyrosine, Patient, Light, Nosebleed, Intellectual disability, Itch, Ageing, Diet, Keratitis, Skin, Pharmacy, Tongue, Rash, DSM-IV codes, Allergy, Blood, Leukopenia, Photophobia, Mouth ulcer, Phenylalanine, Erythroderma, Tell, Insurance, Face, Breast milk, Plasma, Nursing

DEER PARK, Ill., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced the commercial availability of Nitisinone Capsules for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Please see important safety information below. Tyrosinemia type 1 is an ultra-rare condition that is estimated to impact fewer than 500 patients in the United States.

Key Points: 
  • We believe that our existing commercial infrastructure and strong patient support services should help us capture a meaningful percentage of the estimated $50 million annual Nitisinone market,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
  • Nitisinone Capsules are available exclusively through Optime Care, a specialty pharmacy dedicated to helping patients with rare diseases manage their conditions.
  • Optime Care will administer the Eton Cares Program in partnership with Eton Pharmaceuticals.
  • To report a suspected adverse event related to Nitisinone, contact Eton Pharmaceuticals, Inc. at: 1-855-224-0233 or the US Food and Drug Administration at www.fda.gov/medwatch or call 1-800-FDA-1088.

Eyenovia Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 13, 2023
CNS, Acquisition, Mydriasis, Audit committee, Telecanthus, Visual acuity, CFO, Headache, Net, Patient, Presbyopia, Research, Element, Tropicamide, Lomb, Growth, Inflammation, Vomiting, Intraocular pressure, ACE, ADT Inc., American Academy, Abnormal psychology, New Drug Application, Nausea, Tachycardia, Mouth, Hypersensitivity, NDA, Allied health professions, International Joint Commission, Photophobia, Psychotic Reaction, Cholinergic, Pilocarpine, Pallor, Reader's Digest, Blood pressure, Bausch, Carbachol, Near-sightedness, Allergy, FDA, Contact, Central nervous system, PDUFA, Hypertonia, Pharmaceutical industry, Management, Nursing, Telescopic sight, Video game, Euronext, Ophthalmology

NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage, topical ophthalmic company leveraging its Optejet® dispensing technology for both internally developed and acquired programs as well as out-licensing for additional indications, today announced its financial and operating results for the third quarter ended September 30, 2023.

Key Points: 
  • Advanced its Gen-2 Optejet device and anticipates shipping to MicroPine partners Bausch and Lomb and Arctic Vision by year-end 2023.
  • Research and development expenses totaled approximately $3.6 million for the third quarter of 2023 as compared to $3.9 million for the third quarter of 2022.
  • For the third quarter of 2023, general and administrative expenses were approximately $2.9 million, compared to $3.4 million for the third quarter of 2022.
  • Total operating expenses for the third quarter of 2023 were approximately $6.5 million compared to $7.2 million for the third quarter of 2022.

Introducing Neurolux™: Revolutionizing Relief for Migraine and Photophobia Sufferers with a Dual-Pair Solution

Retrieved on: 
Wednesday, December 13, 2023
Blepharospasm, Migraine, Health, Photophobia, Lens, Telescopic sight

An innovative solution for people who suffer from light sensitivity and migraines is finally here.

Key Points: 
  • An innovative solution for people who suffer from light sensitivity and migraines is finally here.
  • The first Neurolux™ pair, designed for daily use, offers consistent relief from light sensitivity, enhancing visual comfort, and reducing the frequency of migraine triggers.
  • The second pair, Neurolux™ Active Migraine, is crafted for times of intense symptoms, providing an extra layer of protection and soothing relief during severe migraine episodes.
  • "Migraines and photophobia can be debilitating, but we believe that relief should not be a luxury," said Dr. Marc Weinstein, CEO of Value Eyecare Network.

TheraSpecs® Announces Groundbreaking New Product Lines to Tackle Brain Injuries, Epilepsy, and More

Retrieved on: 
Thursday, December 7, 2023
Brain, Sleep, Migraine, Research, Catalog, Lens, Photosensitive epilepsy, Headache, Concussion, Multimedia, Light, Health, Seizure, Photophobia, GLARE, Epilepsy, Insomnia, Flex, Post-concussion syndrome, Telescopic sight, Camera, PHOENIX

PHOENIX, Dec. 7, 2023 /PRNewswire-PRWeb/ -- TheraSpecs® Company, the leading brand of therapeutically tinted glasses for migraine and light sensitivity, today announced multiple new product lines designed for a wide range of additional symptoms, conditions, and situations. As the first company to offer such a line direct to consumers, TheraSpecs is positioned to help millions with brain injuries, photosensitive epilepsy, insomnia, and computer headaches.

Key Points: 
  • As the first company to offer such a line direct to consumers, TheraSpecs is positioned to help millions with brain injuries, photosensitive epilepsy, insomnia, and computer headaches.
  • "I started TheraSpecs in 2011 to help my wife and people like her with debilitating chronic migraine," said founder and CEO, Hart Shafer.
  • They've been made even better with the addition of premium optical coatings that further reduce scratches, smudges, and glare.
  • These are hands down the best product I have ever invested in and my overall health and well-being has been positively impacted!"

Orchard Therapeutics Announces Presentation of Additional Positive Data from Proof-of-concept Study of OTL-203 in MPS-IH at ESGCT 2023

Retrieved on: 
Thursday, October 26, 2023
Glycosaminoglycan, Heart, Hurler syndrome, Hearing loss, Congress, Photophobia, POC, ERT, IDUA, Cell, Disease, MPS, Antibody, Gene, San Raffaele Hospital, HSC, The New England Journal of Medicine, ESGCT, Eye, Safety, European Society for Primary Immunodeficiencies, Therapy, Patient, Diagnosis, Death, Hurler, San Raffaele, European Society of Gene and Cell Therapy, HSCT, Pharmaceutical industry, Medical device, Medical imaging

The data were presented at the European Society of Gene and Cell Therapy (ESGCT) 30th Annual Congress taking place October 24-27, 2023, in Brussels.

Key Points: 
  • The data were presented at the European Society of Gene and Cell Therapy (ESGCT) 30th Annual Congress taking place October 24-27, 2023, in Brussels.
  • “The complications associated with MPS-IH involve multiple organ systems and have an adverse impact on patients’ quality of life.
  • Importantly, following treatment with OTL-203, no patients reported photophobia (light sensitivity), or any other ophthalmological symptoms typically associated with MPS-IH.
  • Secondary endpoints include biochemical markers, additional clinical assessments, as well as safety and tolerability.

Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone

Retrieved on: 
Wednesday, October 4, 2023
Insurance, Cornea, Keratitis, US Foods, Tyrosine, Diet, Medicine, Tell, Face, Chapter 11, Title 11, United States Code, Erythroderma, Skin, Light, DSM-IV codes, Inflammation, Carglumic acid, Mouth ulcer, Rash, Phenylalanine, Intellectual disability, Eton, Plasma, Vitamin, Hair, Photophobia, Allergy, Patient, Leukopenia, Blood, Itch, Immune system, Cover My Eyes (Pain and Heaven), Ageing, Rare, FDA, Conjunctivitis, Nosebleed, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Thrombocytopenia, Tongue, Food, Breast milk, Pharmaceutical industry, Nursing, Dietary supplement, Medical imaging, Birth control, Nitisinone

DEER PARK, Ill., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced it has entered into an agreement to acquire an abbreviated new drug application for Nitisinone Capsules via Oakrum Pharma, LLC’s Chapter 11 bankruptcy proceeding. The transaction has been approved by the bankruptcy court and is expected to be effective on October 12, 2023. The acquired product was approved by the U.S. Food and Drug Administration (FDA) in May of 2023 for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. It is estimated that less than 500 patients in the United States suffer from this ultra-rare condition.

Key Points: 
  • Nitisinone is our fourth FDA-approved product, and further advances us toward our goal of having ten commercial rare disease products on the market by the end of 2025.
  • Eton expects to launch the product in the first quarter of 2024 and plans to offer its Eton Cares support program to all patients.
  • Nitisinone is a prescription medicine used to treat adults and children with a hereditary disease called tyrosinemia type 1 (HT-1).
  • To report a suspected adverse event related to Nitisinone, contact Eton Pharmaceuticals, Inc. at: 1-855-224-0233 or the US Food and Drug Administration at www.fda.gov/medwatch or call 1-800-FDA-1088.

Eyenovia Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 10, 2023
Hypersensitivity, Blood pressure, Contact, Pallor, Central nervous system, Allergy, Mydriasis, Presbyopia, Cholinergic, Abnormal psychology, Tropicamide, Optometry, Pilocarpine, CNS, Sale, Tachycardia, Hypertonia, Intraocular pressure, Vomiting, ET, Photophobia, Russell, Patient, Physician, Psychotic Reaction, PDUFA, Nausea, Research, FDA, Headache, Visual acuity, Carbachol, Mouth, Cryptocurrency, Pharmaceutical industry, Property management, Medical device, Video game, Telescopic sight

NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide+phenylephrine ophthalmic spray) for mydriasis and developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced its financial and operating results for the second quarter ended June 30, 2023.

Key Points: 
  • Advanced its pre-NDA presbyopia program, Apersure (Microline), and anticipates commencing the manufacture of registration batches in the fourth quarter of 2023.
  • Research and development expenses totaled approximately $2.8 million for the second quarter of 2023 as compared to $3.6 million for the second quarter of 2022.
  • For the second quarter of 2023, general and administrative expenses were approximately $3.1 million, compared to $3.5 million for the second quarter of 2022.
  • Total operating expenses for the second quarter of 2023 were approximately $6.0 million compared to $7.1 million for the second quarter of 2022.

Eyenovia Announces First Commercial Sale of Mydcombi™

Retrieved on: 
Thursday, August 3, 2023
Hypersensitivity, Blood pressure, Contact, US Foods, Pallor, Central nervous system, Mouth, Allergy, Mydriasis, Presbyopia, Cholinergic, Ophthalmology, Abnormal psychology, Tropicamide, Optometry, CNS, Pilocarpine, Sale, Tachycardia, Hypertonia, Intraocular pressure, Vomiting, Photophobia, Patient, Psychotic Reaction, Nausea, FDA, Headache, Visual acuity, Carbachol, Food, Phenylephrine, Pharmaceutical industry, Telescopic sight

NEW YORK, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis and developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced the first commercial sale of Mydcombi. Mydcombi was approved by the US Food and Drug Administration on May 8, 2023. The initial sale was to world-renowned board-certified ophthalmologist Dr. Nathan M. Radcliffe, who has become the first physician in the U.S. to incorporate Mydcombi into his daily practice.

Key Points: 
  • Mydcombi was approved by the US Food and Drug Administration on May 8, 2023.
  • The initial sale was to world-renowned board-certified ophthalmologist Dr. Nathan M. Radcliffe, who has become the first physician in the U.S. to incorporate Mydcombi into his daily practice.
  • The product should not be used in patients with known hypersensitivity to any component of the formulation.
  • To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch)

Eyenovia Announces Addition to Russell 2000® and Russell 3000® Indexes

Retrieved on: 
Monday, June 26, 2023
Pallor, Central nervous system, Allergy, Mydriasis, Presbyopia, Cardiovascular disease, FTSE Russell, Tropicamide, Russell Indexes, Tachycardia, Intraocular pressure, Vomiting, Hypertonia, Photophobia, Russell, Patient, Blood pressure, Nausea, Growth, FDA, Headache, Visual acuity, Hyperthyroidism, Mouth, Pharmaceutical industry, Cryptocurrency

Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of April 28, ranking them by total market capitalization.

Key Points: 
  • Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of April 28, ranking them by total market capitalization.
  • FTSE Russell determines membership for its Russell indexes primarily by objective, market capitalization rankings and style attributes.
  • “Our addition into the widely followed Russell Indexes is another important milestone reflecting the significant progress we have made in advancing our ophthalmic delivery platform,” stated Michael Rowe, chief executive officer of Eyenovia.
  • For more information on the Russell 3000® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website .

Eyenovia Announces Presentation at the OCTANE Ophthalmology Tech Forum 2023

Retrieved on: 
Thursday, June 1, 2023
Pallor, Central nervous system, Allergy, Mydriasis, Presbyopia, Cardiovascular disease, PDT, Tropicamide, Tachycardia, Hypertonia, Intraocular pressure, Vomiting, Photophobia, Patient, Ophthalmology, Blood pressure, Nausea, Commercial Operating System, FDA, Headache, Visual acuity, Hyperthyroidism, Mouth, Phenylephrine, Generic drug, Pharmaceutical industry

NEW YORK, June 01, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that the company will be delivering a presentation at the annual OCTANE Ophthalmology Tech Forum 2023, which is being held June 8-9 in Newport Beach, CA.

Key Points: 
  • The presentation is scheduled for Friday, June 9th at 5:00 p.m. PDT.
  • “The theme of this year’s OCTANE forum, ‘Future Focused,’ will highlight recent innovations that will shape the future of ophthalmology, and we believe our novel Optejet technology will do just that,” stated Michael Rowe, chief executive officer of Eyenovia.
  • Central Nervous System Disturbances: Caution in pediatric patients where rare incidences of central nervous system disturbances have been reported.
  • To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch)