Microcline

Microline Surgical Expands Healthcare Products Offering with Acquisition of Surgical Instrumentation Assets from Retraction Limited

Retrieved on: 
Wednesday, November 22, 2023
Health, Surgery, Medical Supplies, Medical Devices, Sale, Acquisition, End-of-life care, Commitment, Liver, Surgeon, Patient, HDD, Instrument, Glasses, LCD, Information technology, Hoya Corporation, Microcline

Microline Surgical, Inc. (“Microline” or the “Company”), a subsidiary of HOYA Corporation, today announced that it has acquired the rights to certain laparoscopic instrumentation assets from RETRACTION Limited.

Key Points: 
  • Microline Surgical, Inc. (“Microline” or the “Company”), a subsidiary of HOYA Corporation, today announced that it has acquired the rights to certain laparoscopic instrumentation assets from RETRACTION Limited.
  • The acquisition includes REVEEL branded products, which are used by surgeons for liver retraction in laparoscopic surgeries.
  • Microline Surgical is a medical technology company specializing in the design, development, and manufacture of advanced surgical instruments.
  • Microline Surgical offers a diverse range of surgical instruments, including graspers, dissectors, scissors, and specialized instruments tailored to specific surgical procedures.

Eyenovia Announces FDA Approval of Mydcombi™, the First Ophthalmic Spray for Mydriasis, Which Also Leverages the Company’s Proprietary Optejet® Device Platform

Retrieved on: 
Monday, May 8, 2023
Hypersensitivity, Glaucoma, Microcline, Pallor, Central nervous system, Mouth, Allergy, Mydriasis, Presbyopia, Cardiovascular disease, Tropicamide, Tachycardia, Intraocular pressure, Vomiting, Hypertonia, Photophobia, Patient, Blood pressure, Webcast, Nausea, FDA, Headache, Visual acuity, Hyperthyroidism, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Phenylephrine, Pharmaceutical industry, Medical device

NEW YORK, May 08, 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 U.S. Food and Drug Administration (FDA) has approved Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. This represents the first approved fixed dose combination of tropicamide and phenylephrine in the United States and also the first product using Eyenovia’s proprietary Optejet device to be approved by any regulatory authority.

Key Points: 
  • The product is contraindicated and should not be used in patients with known hypersensitivity to any component of the formulation.
  • We see opportunities to unlock significant opportunities in the future treatment of other ophthalmic conditions including glaucoma and dry eye.
  • Most common ocular adverse reactions include transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort.
  • 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 Reports Third Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 10, 2022
MAP, GLOBE, Forward-looking statement, Marketing, Pilocarpine, Congress, Phenylephrine, Eye, Mydriasis, Myopia, Technology, Presbyopia, Electronics, COVID-19, Efficiency, Visual acuity, Annual report, CA, Safety, U.S. Securities and Exchange Commission, Achievement, Compliance, Time, Senior, Company, Bausch & Lomb, Research, Reflex, Patient, ET, Pupil, Therapy, Microcline, FDA, Pharmaceutical industry, Management, Telescopic sight, Operation

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.

Eyenovia Announces Positive Results from VISION-2 Phase 3 Study of MicroLine as a Potential On-Demand Treatment for Presbyopia

Retrieved on: 
Thursday, October 20, 2022
U.S. Securities and Exchange Commission, Pupil, Microcline, Efficiency, Therapeutic index, New Drug Application, Myopia, NDA, NASDAQ, Patient, Lens (anatomy), MAP, Technology, Eye, Marketing, Headache, Pilocarpine, Toxicity, Incidence, Safety, Presbyopia, GLOBE, Forward-looking statement, OD, Mydriasis, FDA, COVID-19, Phenylephrine, Visual acuity, Pharmaceutical industry, Medical imaging, Risk management, Telescopic sight

VISION-2 is the fourth Phase 3 study demonstrating the utility of the companys MAP technology in improving the therapeutic index of topical ophthalmic drugs.

Key Points: 
  • VISION-2 is the fourth Phase 3 study demonstrating the utility of the companys MAP technology in improving the therapeutic index of topical ophthalmic drugs.
  • We are very pleased with these Phase 3 study results which again demonstrate the benefits of our proprietary Optejet device that underpins MicroLine as a potential on-demand treatment for presbyopia, stated Michael Rowe, Chief Executive Officer of Eyenovia.
  • We look forward to meeting with the FDA within our planned commercialization timeline in preparation for a potential new drug application (NDA) submission.
  • The VISION-2 study was a double-masked, placebo-controlled, cross-over superiority trial in which 140 subjects with presbyopia were treated.

Eyenovia's Novel Optejet® Dispenser Puts People's Eyes First

Retrieved on: 
Tuesday, August 30, 2022
COVID-19, CEO, Technology, Ophthalmology, NASDAQ, Mydriasis, Stinger, Glaucoma, Physician, Presbyopia, U.S. Securities and Exchange Commission, Microcline, GLOBE, Therapy, Face, Eye, Forward-looking statement, Marketing, Patient, MAP, Pharmaceutical industry, Myopia

NEW YORK, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP) therapeutics, brings human-centric design to ophthalmology with its novel Optejet dispenser.

Key Points: 
  • NEW YORK, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP) therapeutics, brings human-centric design to ophthalmology with its novel Optejet dispenser.
  • Eyenovia's easy-to-use, novel Optejet dispenser administers precisely 8L of medication to the eye, effectively treating the patient's condition while creating a more gentle dosing experience.
  • "The unique delivery mechanism oftheOptejet will fundamentally change how we think about eye medication," said Michael Rowe, CEO of Eyenovia.
  • Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements.

China Presbyopia Market Insight, Epidemiology and Market Forecasts, 2019-2022 & 2022-2032 - ResearchAndMarkets.com

Retrieved on: 
Thursday, August 11, 2022
Health, Optical, FDA, III, Lens (anatomy), Hole, CDE, Population, Nepafenac, AbbVie, Pilocarpine, Clinical trial, Microcline, IND, Business, Research, Gao Jixing, Pupil, Therapy, Adult, Center, Center for Drug Evaluation and Research, Eye, NMPA, SWOT, Ophthalmology, Report, Safety, National Medical Products Administration, Elasticity, Nonsteroidal anti-inflammatory drug, Efficiency, GEMINI, Pharmaceutical industry, Telescopic sight, Dietary supplement, Animal, Engineered wood, Presbyopia, Carbachol, Epidemiology, Allergan, Visu

This 'Presbyopia - China Market Insight, Epidemiology, and Market Forecast-2032' report deliver an in-depth understanding of Presbyopia, historical and forecasted epidemiology as well as the Presbyopia market trend in China.

Key Points: 
  • This 'Presbyopia - China Market Insight, Epidemiology, and Market Forecast-2032' report deliver an in-depth understanding of Presbyopia, historical and forecasted epidemiology as well as the Presbyopia market trend in China.
  • The Presbyopia market report provides current treatment practices, emerging drugs, market share of the individual therapies, and current and forecasted China Presbyopia market size from 2019 to 2032.
  • The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of Presbyopia, total diagnosed cases of Presbyopia, total age-specific cases of Presbyopia, gender-specific cases of Presbyopia, and severity-specific cases of Presbyopia scenario of Presbyopia in China from 2019 to 2032.
  • The market size of Presbyopia in China was USD 14,375 million in 2021, which is further expected to increase by 2032.

Eyenovia Reports Second Quarter 2022 Financial Results

Retrieved on: 
Wednesday, August 10, 2022
FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Manufacturing & Service Operations Management, Phenylephrine, Reflex, Electronics, Presbyopia, U.S. Securities and Exchange Commission, Running, NDA, Forward-looking statement, GLOBE, Senior, CA, Technology, Visual acuity, Microcline, Board, Director, Annual report, ET, Compliance, Pilocarpine, Myopia, Pupil, Mydriasis, Marketing, COVID-19, Company, Eye, Therapy, MAP, Research, New Drug Application, Ophthalmology, Time, Food, Efficiency, Management, Medical device, Pharmaceutical industry, Video game, Telescopic sight

NEW YORK, Aug. 10, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (Nasdaq: EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, today announced its financial and operating results for the second quarter ended June 30, 2022.

Key Points: 
  • Total license revenue was $0.0 million for the second quarter of 2022 as compared to $2.0 million for the second quarter of 2021.
  • Research and development expenses totaled approximately $3.6 million for the second quarter of 2022 as compared to $3.7 million for the second quarter of 2021, a decrease of approximately (2.7%).
  • For the second quarter of 2022, general and administrative expenses were approximately $3.5 million, compared to $2.3 million for the second quarter of 2021, an increase of approximately 53.8%.
  • Total operating expenses for the second quarter of 2022 were approximately $7.1 million compared to $6.0 million for the second quarter of 2021.

Eyenovia Provides Manufacturing Update and Announces Appointment of Bren Kern as SVP of Manufacturing and Operations

Retrieved on: 
Monday, July 18, 2022
Research, Â, Manufacturing & Service Operations Management, U.S. Securities and Exchange Commission, Solution, Therapy, Engineering, GLOBE, Forward-looking statement, Presbyopia, Technology, Insurance, Marketing, NASDAQ, Organization, Silicon, COVID-19, Microcline, Company, CGMP, PMA, CA, Senior, Bausch & Lomb, Myopia, Mydriasis, Pharmaceutical industry, Management, Medical device

With our Redwood City facility now operational, Eyenovia has internal manufacturing capabilities to complement our existing contract manufacturing partners, stated Michael Rowe, Chief Operating Officer of Eyenovia.

Key Points: 
  • With our Redwood City facility now operational, Eyenovia has internal manufacturing capabilities to complement our existing contract manufacturing partners, stated Michael Rowe, Chief Operating Officer of Eyenovia.
  • Eyenovia also announced today the appointment of Bren Kern as the Companys new Senior Vice President of Manufacturing and Operations.
  • I look forward to contributing to the team and championing our internal manufacturing and engineering operations to help bring these exciting solutions to market.
  • Mr. Kern has spent his career helping companies transition from research and development entities into scaled commercial manufacturing organizations.

Eyenovia Strategic Partner Arctic Vision Enrolls First Patient in Phase III Clinical Trial of ARVN003 (MicroLine) for Presbyopia in China

Retrieved on: 
Wednesday, July 6, 2022
Ageing, Patient, List, GLOBE, Marketing, COVID-19, Population, Ministry, U.S. Securities and Exchange Commission, Mydriasis, Forward-looking statement, Risk, Partnership, Therapy, Vision, Clinical trial, Presbyopia, Technology, NASDAQ, Microcline, Education, NDA, Myopia, Pharmaceutical industry

This marks the first time that a clinical trial has been approved in China to evaluate a pharmacologic treatment for presbyopia.

Key Points: 
  • This marks the first time that a clinical trial has been approved in China to evaluate a pharmacologic treatment for presbyopia.
  • In August 2020, Arctic Vision obtained from Eyenovia an exclusive license for the development and commercialization of ARVN003 (MicroLine) in Greater China and South Korea.
  • Subsequent to this original agreement, Arctic Vision also licensed Eyenovias development-stage candidate for pharmacological mydriasis, MydCombi.
  • In parallel, Arctic Vision continues work on its other two Eyenovia licensed programs - pediatric progressive myopia (MicroPine) and pharmacologic mydriasis (MydCombi).

Arctic Vision Announces First Patient Enrolled in Phase III Clinical Trial of ARVN003 for Presbyopia

Retrieved on: 
Monday, July 4, 2022
Ageing, Patient, Life, Electronics, DME, Trial of the century, Population, Disease, MAP, Phase, Compliance, Presbyopia, Latanoprost, Ciliary muscle, Mapy Cortés, Vision, Clinical trial, Technology, Visual acuity, IOP, The Affiliated Eye Hospital, Lens (anatomy), Entrepreneurship, Wenzhou Medical University, Time, Microcline, Safety, Pupil, Eye, Pilocarpine, Principal investigator, Pharmaceutical industry, Telescopic sight

SHANGHAI, July 4, 2022 /PRNewswire/ -- Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, today announced that the first patient has been enrolled in a Phase III clinical study evaluating ARVN003, a proprietary pilocarpine formulation leveraging its micro dosing platform Optejet®, as a treatment to temporarily improve vision in adults with presbyopia in China.

Key Points: 
  • This is the first clinical trial approved in China for presbyopia drugs and Arctic Vision's study marks the first patient enrollment in a Phase III clinical trial for presbyopia drugs in China.
  • The Phase III study is double-masked, placebo-controlled, randomized, and multicenter trial evaluating the efficacy and safety of ARVN003 in achieving temporary improvement of vision in adults with presbyopia.
  • It is the first clinical trial approved in China for presbyopia drugs and Arctic Vision's study marks the first patient enrollment in a Phase III clinical trial for presbyopia drugs in China.
  • Dr. Qing Liu, Co-Founder and Chief Medical Officer at Arctic Vision added, "ARVN003's significant clinical progress is encouraging.