Mydriasis

Ocuphire Pharma Announces Financial Results for Fourth Quarter and Full Year 2023 and Provides Corporate Update

Retrieved on: 
Friday, March 8, 2024

In October 2023, Ocuphire held an End-of-Phase 2 meeting with the FDA and aligned on the registrational primary endpoint of 3-step or more worsening on binocular DRSS Person scale.

Key Points: 
  • In October 2023, Ocuphire held an End-of-Phase 2 meeting with the FDA and aligned on the registrational primary endpoint of 3-step or more worsening on binocular DRSS Person scale.
  • In February 2024, Ocuphire submitted a Special Protocol Assessment (“SPA”) to seek agreement on the clinical trial protocol and statistical analysis plan for Phase 3.
  • In September 2023, Ocuphire and Viatris, Inc. (“Viatris”) announced FDA approval of PS under the brand name RYZUMVI™ for the treatment of pharmacologically-induced mydriasis.
  • Financial Highlights for the Fourth Quarter and Full Year Ended December 31, 2023
    As of December 31, 2023, Ocuphire had cash and cash equivalents of approximately $50.5 million.

Eyenovia Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 13, 2023

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.

Ocuphire Pharma Announces Financial Results for Third Quarter 2023 and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023

FARMINGTON HILLS, Mich., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • Named as CEO; Conference Call Scheduled for December 5th, 2023, at 10 AM ET
    FARMINGTON HILLS, Mich., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.
  • On August 10, 2023, Ocuphire entered into a common share purchase agreement with Lincoln Park Capital Fund, LLC (“LPC”).
  • Third Quarter ended September 30, 2023, Financial Highlights
    As of September 30, 2023, Ocuphire had cash and cash equivalents of approximately $42.4 million.
  • For further details on Ocuphire’s financial results, refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, to be filed with the Securities and Exchange Commission.

Eyenovia to Report Third Quarter 2023 Results on Monday, November 13

Retrieved on: 
Monday, November 6, 2023

Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. EDT to review the financial and operating results.

Key Points: 
  • Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. EDT to review the financial and operating results.
  • Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international) and referencing conference ID 13741898.
  • To access the Call me™ feature, which avoids having to wait for an operator, click here .
  • After the live webcast, the event will be archived on Eyenovia’s website for one year.

Eyenovia Announces FDA Approval of Coastline International as Contract Manufacturer to Initiate Mydcombi Commercial Production

Retrieved on: 
Thursday, November 2, 2023

Coastline will manufacture cartridge subassemblies for Mydcombi, the only FDA-approved tropicamide and phenylephrine hydrochloride fixed combination for mydriasis (office-based pupil dilation).

Key Points: 
  • Coastline will manufacture cartridge subassemblies for Mydcombi, the only FDA-approved tropicamide and phenylephrine hydrochloride fixed combination for mydriasis (office-based pupil dilation).
  • “One of the many benefits of Mydcombi is that, unlike eye droppers, there is no protruding tip that can come in contact with the patient’s eye.
  • “We believe Mydcombi, because of its design, addresses this challenge and can provide significant cost savings to doctors and surgical centers.
  • With FDA approval of Coastline, our manufacturing capabilities are in place, and we anticipate initiating Mydcombi commercial production imminently with the goal of having product available to ship in January of 2024.”

Eyenovia to Sponsor Course on Drug Delivery Innovation at IJCAHPO’s 51st Annual Continuing Education (ACE) Program

Retrieved on: 
Monday, October 30, 2023

NEW YORK, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ for mydriasis, preparing for regulatory approval of APP130007 for relief of pain and inflammation post ocular surgery, and incorporating its advanced 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 it is sponsoring a course during the International Joint Commission on Allied Health Personnel in Ophthalmology (IJCAHPO) 51st Annual Continuing Education (ACE) program, which is being held November 3-5 in San Francisco.

Key Points: 
  • The course, Topical Pharmaceutical Drug Delivery Innovations: The Potential Role for the New Ophthalmic Spray, will offer ophthalmic technicians background on Eyenovia’s Optejet dispensing technology and training on the use of Mydcombi in daily practice.
  • “We continue to ramp our internal manufacturing capabilities, staff our sales management team and obtain additional key state licenses of which we now have eight either completed or in process.
  • We look forward to transitioning to a broader commercial launch of Mydcombi in early 2024.”
    Topical Pharmaceutical Drug Delivery Innovations: The Potential Role for the New Ophthalmic Spray
    Francis Mah, M.D., Director of Cornea and External Disease and the Co-Director, Refractive Surgery at Scripps Clinic.
  • In addition, Mydcombi was featured in a white paper on Touch Ophthalmology, Pharmacologic Mydriasis and Cycloplegia: A Review of Novel Delivery Devices, which can be accessed here .

Eyenovia to Present Data on Preservative-Free Microbial Integrity of the Optejet®

Retrieved on: 
Monday, October 9, 2023

NEW YORK, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ for mydriasis, preparing for regulatory approval of APP13007 for relief of pain and inflammation post ocular surgery, and incorporating its advanced Optejet® device with late-stage product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that it will deliver a presentation on the microbial integrity of its Optejet dispensing device at the American Academy of Optometry’s “Academy 2023 New Orleans” Annual Meeting, which is being held October 11-14, 2023.

Key Points: 
  • NEW YORK, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ for mydriasis, preparing for regulatory approval of APP13007 for relief of pain and inflammation post ocular surgery, and incorporating its advanced Optejet® device with late-stage product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that it will deliver a presentation on the microbial integrity of its Optejet dispensing device at the American Academy of Optometry’s “Academy 2023 New Orleans” Annual Meeting, which is being held October 11-14, 2023.
  • “Recent studies of both preserved and preservative-free multi-use eye drops have shown contamination rates as high as 94%, suggesting that there is an urgent need for a next-generation topical ophthalmic drug dispensing device that can administer medication without preservatives or contaminants, both of which can be harmful to the eye,” stated Michael Rowe, chief executive officer of Eyenovia.
  • “This study successfully demonstrates the Optejet’s ability to maintain product sterility even when exposed to a microbial load that exceeds typical environmental conditions, supporting the potential for the Optejet to be used to deliver preservative-free medications, which would confer significant long-term benefits to patients.”

Viatris and Ocuphire Pharma Announce FDA Approval of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% Eye Drops for the Treatment of Pharmacologically-Induced Mydriasis Produced by Adrenergic Agonists (e.g., Phenylephrine) or Parasympatholytic (e.g., Tro

Retrieved on: 
Wednesday, September 27, 2023

PITTSBURGH, and FARMINGTON HILLS, Mich., Sept. 27, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved RYZUMVI™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.  RYZUMVl is expected to be commercially available in the U.S. in the first half of 2024.

Key Points: 
  • RYZUMVl is expected to be commercially available in the U.S. in the first half of 2024.
  • Our hope is that by addressing patient dilation barriers, we're empowering eye care professionals to broaden exam availability, leading to enhanced eye health outcomes.
  • Two drops (study eye) or one drop (fellow eye) of RYZUMVI or placebo (vehicle) were administered one hour after instillation of the mydriatic agent.
  • The efficacy of RYZUMVI was similar for all age ranges including pediatric subjects aged 3 to 17 years.

Ocuphire Pharma and Viatris Announce FDA Approval of RYZUMVI™ (Phentolamine Ophthalmic Solution) 0.75% Eye Drops for the Treatment of Pharmacologically-Induced Mydriasis Produced by Adrenergic Agonists (e.g., Phenylephrine) or Parasympatholytic (e.g., Tro

Retrieved on: 
Wednesday, September 27, 2023

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

Key Points: 
  • RYZUMVI is expected to be commercially available in the U.S. in the first half of 2024.
  • Our hope is that by addressing patient dilation barriers, we’re empowering eye care professionals to broaden exam availability, leading to enhanced eye health outcomes.
  • Two drops (study eye) or one drop (fellow eye) of RYZUMVI or placebo (vehicle) were administered one hour after instillation of the mydriatic agent.
  • The efficacy of RYZUMVI was similar for all age ranges including pediatric subjects aged 3 to 17 years.

Eyenovia to Participate in Panel Discussion at Cantor Global Healthcare Conference

Retrieved on: 
Thursday, September 21, 2023

NEW YORK, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (Nasdaq: EYEN), an ophthalmic technology company commercializing Mydcombi™ for mydriasis, preparing for regulatory approval of AP13007 for relief of pain and inflammation post ocular surgery, and incorporating its advanced 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 Michael Rowe, CEO, will be participating in a panel discussion at the Cantor Global Healthcare Conference, which is taking place September 26-28, 2023, in New York.

Key Points: 
  • NEW YORK, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (Nasdaq: EYEN), an ophthalmic technology company commercializing Mydcombi™ for mydriasis, preparing for regulatory approval of AP13007 for relief of pain and inflammation post ocular surgery, and incorporating its advanced 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 Michael Rowe, CEO, will be participating in a panel discussion at the Cantor Global Healthcare Conference, which is taking place September 26-28, 2023, in New York.