Mydriasis | Jotup

Eyenovia Reports First Quarter 2024 Financial Results and Provides Updates on its Myopia Phase III Program and its Two FDA Approved Commercial Products, Mydcombi and Clobetasol

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Mercredi, mai 15, 2024

Patient, Mydriasis, University, FDA, Clinical trial, Vision Source, Clobetasol, Growth, Research, Data monitoring committee, Inflammation, Pain, Pharmaceutical industry

NEW YORK, May 15, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced its financial and operating results for the first quarter ended March 31, 2024.

Key Points:

External sources have valued the pediatric progressive myopia market at over $3.0 billion annually in the U.S. and China.
Announced FDA approval of clobetasol propionate ophthalmic suspension 0.05% for the treatment of inflammation and pain following ocular surgery.
Eyenovia is planning a launch of this product in the third quarter of 2024.
Reduced the Company’s anticipated cash-based expenses by approximately $0.8 million per quarter from first quarter 2024 actual levels.

Eyenovia Provides Clinical and Scientific Update on FDA-Approved Products Mydcombi™ and Clobetasol Propionate Ophthalmic Suspension

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Jeudi, avril 25, 2024

Pain, FDA, Clobetasol, Inflammation, Phenylephrine, The central science, Solubility, Food, Research, State university system, Mydriasis, OD, Patient, Annual general meeting, Tropicamide, ARVO, Pharmaceutical industry

NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today provided an update on its two FDA-approved products.

Key Points:

NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today provided an update on its two FDA-approved products.
Eyenovia is planning to launch clobetasol later this summer, as a complement to Mydcombi, the company’s commercially available mydriasis agent.
“We look forward to incorporating this technology in future products, as well as launching clobetasol which uses APNT.
Clobetasol will be the first new ophthalmic steroid in many years, participating in a market estimated to be worth in excess of $1.3 billion annually.”

Eyenovia Announces Updated Strategy and Corporate Priorities to Focus on Shareholder Value Generation and Immediate Commercial Opportunities

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Lundi, avril 8, 2024

Organization, Clobetasol, Disease, Inflammation, Near-sightedness, Sale, NDA, Mydriasis, Pain, FDA, Pharmaceutical industry

In conjunction with the strategic process and focus on its late stage MicroPine asset, Eyenovia reiterated its immediate commercialization opportunities and corporate savings intended to reduce operating expenses while continuing to support meaningful value generation from the company's two FDA-approved products.

Key Points:

In conjunction with the strategic process and focus on its late stage MicroPine asset, Eyenovia reiterated its immediate commercialization opportunities and corporate savings intended to reduce operating expenses while continuing to support meaningful value generation from the company's two FDA-approved products.
“The pediatric progressive myopia market represents a significant opportunity for Eyenovia both in the United States and China.
This disease, for which there are no FDA-approved pharmaceutical treatments, has been called an epidemic by several medical and optometric organizations.
Eyenovia does not intend to make any further disclosures regarding the strategic review process unless and until a specific course of action is approved.

Viatris Announces the Launch of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% in the United States

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Lundi, avril 1, 2024

PITTSBURGH, April 1, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced the U.S. commercial launch of 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 in the United States.

Key Points:

PITTSBURGH, April 1, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced the U.S. commercial launch of 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 in the United States.
The onset of action of RYZUMVI generally occurs in 30 minutes.
In the MIRA-2 trials' placebo group, 34% of patients were still dilated (had not returned to ≤ 0.2 mm of baseline pupil diameter) at 24 hours.
To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface.

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

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Vendredi, mars 8, 2024

OCUP, Research, Mydriasis, FDA, Protocol, PS, Presbyopia, Calendar, Diabetic retinopathy, Interim, Safety, DR, Diabetes, Patient, SPA, Security (finance), Ash, LPC, Pharmaceutical industry

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

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Lundi, novembre 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

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Lundi, novembre 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

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Lundi, novembre 6, 2023

Mydriasis, Pain, Webcast, EDT, Inflammation, Presbyopia, Pharmaceutical industry

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

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Jeudi, novembre 2, 2023

FDA, Phenylephrine, Mydriasis, Pain, Surgeon, Risk, Tropicamide, Inflammation, Shanda, Presbyopia, Pharmaceutical industry, Medical device

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

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Lundi, octobre 30, 2023

FDA, Refractive surgery, Optometry, Tropicamide, Joint Commission on Allied Health Personnel in Ophthalmology, Presbyopia, ACE, Inflammation, Phenylephrine, American Academy, International Joint Commission, American Academy of Ophthalmology, American Academy of Optometry, Allied health professions, Somatosensory system, Mydriasis, Pain, Pharmaceutical industry, Ophthalmology

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 .