Pilocarpine

Eyenovia Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 13, 2023
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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.

Orasis Pharmaceuticals Announces FDA Approval of QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia

Retrieved on: 
Wednesday, October 18, 2023
Patient, FDA, Cornea, Contact, Headache, Food, Presbyopia, Associate professor, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FACS, Optometry, Night vision, University, Safety, Pilocarpine, Diagnosis, University of Pikeville, Pharmaceutical industry, Telescopic sight, Nursing

QLOSI is expected to be commercially available in the U.S. in the first half of 2024.

Key Points: 
  • QLOSI is expected to be commercially available in the U.S. in the first half of 2024.
  • "The FDA approval of QLOSI marks a tremendous milestone for Orasis as we continue our mission to provide a flexible treatment option for the millions of people in the U.S. living with presbyopia, or blurry near vision," said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals.
  • "I am grateful to the Orasis team, our strategic partners, clinical investigators, and patients who participated in our clinical trials, all of whom made this achievement possible."
  • QLOSI (pronounced CLOH-see) is a prescription eye drop that can be used daily, or as needed, up to twice per day.

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)

EyeCare Partners’ Leadership and Clinical Research to be Showcased at American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting

Retrieved on: 
Thursday, May 4, 2023
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The annual meeting will take place May 5-8, 2023, in San Diego.

Key Points: 
  • The annual meeting will take place May 5-8, 2023, in San Diego.
  • The breadth of topics being presented at ASCRS by ECP physicians emphasizes the company’s culture of innovation and continuous learning.
  • It also underscores the possibility of a career “third pathway” which allows physicians to conduct industry-leading research while also continuing to build a clinical practice.
  • “EyeCare Partners has a strong representation of ophthalmologists presenting research at ASCRS this year, in addition to one of our specialists, Dr. Elizabeth Yeu, serving as the incoming president of ASCRS,” said David Clark, CEO of EyeCare Partners.

Romeg Therapeutics Announces Issuance of U.S. Patent for Pilocarpine Oral Solution

Retrieved on: 
Wednesday, February 1, 2023
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11,564,909 (the '909 patent) directed to the methods and composition of ROMEG's proprietary formulation of pilocarpine.

Key Points: 
  • 11,564,909 (the '909 patent) directed to the methods and composition of ROMEG's proprietary formulation of pilocarpine.
  • The '909 patent reflects a significant addition to Romeg's current intellectual property portfolio and covers the composition claims of pilocarpine oral solution and its therapeutic indications.
  • "We are pleased with the USPTO's issuance of the '909 patent today," said Naomi Vishnupad, Ph.D., Chief Scientific Officer and Partner of Romeg.
  • Romeg is committed to addressing the need of these patients with a palatable, easy to administer pilocarpine oral solution therapy.

Glaukos Announces Positive Clinical Updates for Several Corneal Health Pipeline Programs

Retrieved on: 
Tuesday, January 10, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Ilut, New Drug Application, Duane syndrome, Standard of care, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Keratoconus, Corporation, Safety, Dermis, FDA, Pilocarpine, Glaucoma, Eyelid, NYSE, NDA, Food, Patient, GKOS, DED, Eye, Retina, BID, Pharmaceutical industry, 1870 Glaukos

“These clinical updates represent meaningful milestones for two of our key Corneal Health pipeline programs and we look forward to continuing to advance both of these important programs forward in 2023,” said Thomas Burns, Glaukos chairman and chief executive officer.

Key Points: 
  • “These clinical updates represent meaningful milestones for two of our key Corneal Health pipeline programs and we look forward to continuing to advance both of these important programs forward in 2023,” said Thomas Burns, Glaukos chairman and chief executive officer.
  • Glaukos plans to randomize approximately 290 subjects in this trial and is targeting enrollment completion by the end of 2023.
  • Glaukos also announced promising topline results from its Phase 2a first-in-human clinical trial for GLK-301 (iLution – Dry Eye Disease (DED)) for the signs and symptoms of DED.
  • Based on these encouraging observations, Glaukos plans to advance GLK-301 into a Phase 2b clinical trial targeted to begin in 2023.

MeiraGTx Announces Positive Clinical Data from the AQUAx Phase 1 Clinical Study of AAV2-hAQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia

Retrieved on: 
Tuesday, December 13, 2022
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ET

Key Points: 
  • ET
    LONDON and NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced positive clinical data from the ongoing Phase 1 AQUAx study of AAV2-hAQP1 for the treatment of grade 2/3 radiation-induced xerostomia (RIX).
  • The study is being conducted at 4 centers, 3 in the US and 1 in Canada.
  • All participants are to be followed for 1-year post-treatment and will then enter a long-term follow-up study for an additional 4 years.
  • Secondary endpoints include change from baseline in patient reported measures of xerostomia symptoms as well as whole salivary flow rates.

Ocuphire Pharma Announces Submission of New Drug Application to FDA for Nyxol® Eye Drops for Reversal of Mydriasis

Retrieved on: 
Tuesday, December 6, 2022
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If approved, Nyxol is expected to be the only commercially available treatment option indicated for the reversal of dilated eyes.

Key Points: 
  • If approved, Nyxol is expected to be the only commercially available treatment option indicated for the reversal of dilated eyes.
  • If Nyxol is approved for RM in the US, Ocuphire is eligible to receive a $10 million milestone payment.
  • Nyxol is being developed for reversal of pharmacologically-induced mydriasis (RM), presbyopia, and night (or dim light) vision disturbances (NVD) under the 505(b)(2) pathway.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

Eyenovia Reports Third Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 10, 2022
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NEW YORK, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (Nasdaq: EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced its financial and operating results for the third quarter ended September 30, 2022.

Key Points: 
  • Ended the third quarter of 2022 with approximately $25.3 million in total cash and cash equivalents, including $7.9 million of restricted cash.
  • For the third quarter of 2022, general and administrative expenses were approximately $3.4 million, compared to $2.4 million for the third quarter of 2021, an increase of approximately 41.3%.
  • Total operating expenses for the third quarter of 2022 were approximately $7.2 million compared to $5.9 million for the third quarter of 2021.
  • These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management.