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Eyenovia

Eyenovia logo
🇺🇸United States
Ownership
Public
Established
2014-01-01
Employees
57
Market Cap
$43.8M
Website
http://www.eyenovia.com
Introduction

Eyenovia, Inc. is a clinical stage biopharmaceutical company, which engages in the research and development of ophthalmology products. The company offers a piezo-print technology to deliver micro-doses of micro-therapeutics for the eyes. Its products include MicroProst, MicroStat, MicroTears, and MicroPine. The firm is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression, and mydriasis. The company was founded by Sean Ianchulev on March 12, 2014 and is headquartered in New York, NY.

Clinical Trials

9

Active:0
Completed:8

Trial Phases

4 Phases

Phase 2:1
Phase 3:5
Phase 4:2
+1 more phases

Drug Approvals

2

FDA:2

Drug Approvals

CLOBETASOL PROPIONATE

Approval Date
Mar 22, 2024
FDA

MYDCOMBI

Approval Date
May 9, 2023
FDA

Clinical Trials

Distribution across different clinical trial phases (9 trials with phase data)• Click on a phase to view related trials

Phase 3
5 (55.6%)
Phase 4
2 (22.2%)
Not Applicable
1 (11.1%)
Phase 2
1 (11.1%)

Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation

Phase 4
Completed
Conditions
Mydriasis
First Posted Date
2024-01-22
Last Posted Date
2024-04-18
Lead Sponsor
Eyenovia Inc.
Target Recruit Count
30
Registration Number
NCT06217796
Locations
🇺🇸

SUNY, New York, New York, United States

Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults

Phase 3
Completed
Conditions
Presbyopia
First Posted Date
2021-11-10
Last Posted Date
2023-09-11
Lead Sponsor
Eyenovia Inc.
Target Recruit Count
145
Registration Number
NCT05114486
Locations
🇺🇸

VISION-2 Study Site #57, San Diego, California, United States

🇺🇸

VISION-2 Study Site #59, Fairfield, Connecticut, United States

🇺🇸

VISION-2 Study Site #56, Louisville, Kentucky, United States

and more 6 locations

Evaluation of Pupil Dilation Speed With the MAP Dispenser

Phase 4
Completed
Conditions
Mydriasis
Interventions
Drug: tropicamide-phenylephrine fixed combination ophthalmic solution
First Posted Date
2021-05-28
Last Posted Date
2025-01-09
Lead Sponsor
Eyenovia Inc.
Target Recruit Count
61
Registration Number
NCT04907474
Locations
🇲🇽

CODET Vision Institute, Tijuana, Baja California, Mexico

Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults

Phase 3
Completed
Conditions
Presbyopia
Interventions
First Posted Date
2020-12-08
Last Posted Date
2021-08-09
Lead Sponsor
Eyenovia Inc.
Target Recruit Count
84
Registration Number
NCT04657172
Locations
🇺🇸

VISION-1 Study Site #21, Azusa, California, United States

🇺🇸

VISION-1 Study Site #52, Newport Beach, California, United States

🇺🇸

VISION-1 Study Site #54, Fort Collins, Colorado, United States

and more 6 locations

Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression

Phase 3
Terminated
Conditions
Myopia
Interventions
First Posted Date
2019-05-08
Last Posted Date
2025-01-06
Lead Sponsor
Eyenovia Inc.
Target Recruit Count
438
Registration Number
NCT03942419
Locations
🇺🇸

University of Alabama at Birmingham School of Optometry, Birmingham, Alabama, United States

🇺🇸

Midwestern University, Downers Grove, Illinois, United States

🇺🇸

Canyon City Eyecare, Azusa, California, United States

and more 14 locations
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News

Formosa Pharmaceuticals and Cipla Form Strategic Partnership for APP13007 Commercialization Across 11 Countries

Formosa Pharmaceuticals has granted Cipla Limited exclusive rights to market clobetasol propionate ophthalmic suspension 0.05% (APP13007) across 11 countries in Asia, Africa, and South America.

Eyenovia and Betaliq Plan Reverse Merger to Create Innovative Ophthalmic Technology Company

Eyenovia has entered into a non-binding letter of intent with Betaliq to create a new publicly-listed eye care company valued at approximately $92 million, with Betaliq shareholders owning 83.7% of the combined entity.

Advancements in Clinical Trials for Fabry Disease, C. difficile Infections, and Mydriasis

• Clinical trials are actively progressing for Fabry Disease, with companies like Idorsia and Sanofi Genzyme developing novel therapies. • Emerging treatments like Venglustat and Pegunigalsidase alfa are expected to significantly impact the Fabry Disease market in the coming years. • Research and development efforts are also focused on Clostridium Difficile Infections, with Vedanta Biosciences leading Phase 3 trials for VE303. • Mydriasis treatments are advancing, with companies like Eyenovia exploring solutions like MYDCOMBI for pupil dilation.

Eyenovia's Stock Plummets After Phase III Myopia Trial Fails to Meet Primary Endpoint

Eyenovia's stock price plummeted after its Phase III CHAPERONE study, evaluating a drug-device combination for pediatric progressive myopia, failed to meet its primary endpoint.

Eyenovia's Myopia Trial Fails, Stock Plummets

Eyenovia's stock price plummeted after its Phase III CHAPERONE study for pediatric progressive myopia failed to meet the primary endpoint.

Eyenovia's Phase 3 CHAPERONE Study Fails to Meet Primary Endpoint in Pediatric Myopia

Eyenovia's Phase 3 CHAPERONE study, evaluating low-dose atropine via Optejet for pediatric myopia, did not meet its primary endpoint of less than 0.5 diopter progression over three years.

Eyenovia Halts Phase III Myopia Trial, Explores Strategic Alternatives

Eyenovia discontinues its Phase III clinical trial for a drug-device combination product aimed at treating pediatric myopia after an unfavorable assessment by the data monitoring committee.

Eyenovia's Stock Plummets After Phase III Myopia Study Fails

Eyenovia discontinued its Phase III CHAPERONE study for MicroPine, a low-dose atropine treatment for pediatric progressive myopia, after it failed to meet the primary endpoint.

Eyenovia's Phase 3 CHAPERONE Study Fails to Meet Primary Endpoint in Pediatric Myopia

Eyenovia's Phase 3 CHAPERONE study, evaluating low-dose atropine for pediatric progressive myopia, did not meet its primary endpoint.

Eyenovia's Phase 3 CHAPERONE Study Fails to Meet Primary Endpoint for Pediatric Myopia

Eyenovia's CHAPERONE Phase 3 trial, evaluating low-dose atropine via Optejet for pediatric myopia, did not meet its primary endpoint of slowing myopia progression over three years.

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