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
0 active
Approvals
4
Total approvals
Agencies
1
Regulatory bodies
Founded
2014
Completed
8
88.9%
Terminated
1
11.1%
- Formosa Pharmaceuticals has signed an exclusive licensing agreement with Rxilient Medical for commercialization of APP13007, an FDA-approved clobetasol propionate ophthalmic suspension, across key ASEAN markets including Indonesia, Philippines, Singapore, and Thailand. - APP13007 offers a convenient twice-daily dosing regimen for 14 days without tapering, providing rapid pain relief with approximately 80% of patients pain-free four days post-surgery and less than 2% adverse event incidence. - The licensing territory represents over 1 million annual ocular surgeries with anticipated year-over-year growth, expanding access to this innovative post-surgical treatment option. - This partnership follows previous licensing agreements for APP13007 in the US, Brazil, and Canada, demonstrating the global commercial potential of Formosa's proprietary APNT nanoparticle formulation platform.
- 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. - APP13007, FDA-approved in March 2024, offers a simplified twice-daily dosing regimen for 14 days without tapering for post-operative inflammation and pain following ocular surgery. - This agreement represents Cipla's first multi-regional licensing agreement in ophthalmology and includes upfront payments, royalty milestones, and additional value-driven considerations.
- 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. - The merger would combine Betaliq's EyeSol® water-free drug delivery technology for glaucoma with Eyenovia's Optejet® device platform, potentially creating a revolutionary approach to topical eye medication administration. - If completed, the combined company would continue marketing Eyenovia's FDA-approved products while developing new treatment options for glaucoma and other ocular diseases through established partnerships.
• 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 price plummeted after its Phase III CHAPERONE study, evaluating a drug-device combination for pediatric progressive myopia, failed to meet its primary endpoint. - The CHAPERONE trial assessed low-dose atropine delivered via the Optejet platform but did not demonstrate a statistically significant difference in myopia progression compared to the comparator arm. - Eyenovia is terminating the CHAPERONE study and considering strategic options, including potential business combinations or asset sales, to preserve company value. - Despite this setback, other companies like Vyluma and Johnson & Johnson Vision have recently reported positive data and received FDA approval in the myopia treatment space.
- Eyenovia's stock price plummeted after its Phase III CHAPERONE study for pediatric progressive myopia failed to meet the primary endpoint. - The CHAPERONE trial assessed a low-dose atropine formulation delivered via the Optejet platform but did not demonstrate a significant difference in myopia progression compared to the comparator. - Eyenovia plans to terminate the CHAPERONE study and is considering strategic options, including potential business combinations or asset sales, to preserve company value. - Despite the trial failure, Eyenovia reported that all dosages and the placebo were well-tolerated, with only mild and infrequent adverse events observed.
- 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. - An independent Data Review Committee found no significant difference in myopia progression between the atropine treatment arms (0.01% and 0.1%) and the placebo group. - The company plans to discontinue the CHAPERONE study, conduct a thorough data review, and assess future steps for the myopia program. - Eyenovia is considering strategic options, including potential business combinations or asset sales, to maximize stakeholder value.
- 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. - The committee determined that the trial was unlikely to meet its primary endpoint, leading Eyenovia to cease the study and re-evaluate its strategic direction. - This decision prompts Eyenovia to consider various strategic options, including potential partnerships or a shift in focus, following the termination of the myopia study. - The setback highlights the challenges in developing effective treatments for pediatric myopia and the importance of adaptive trial designs in pharmaceutical research.
- 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. - An independent Data Review Committee found no significant difference in myopia progression between the treatment arms and placebo in the study of 252 patients. - Eyenovia's stock price dropped approximately 70% following the announcement, leading to a downgrade from William Blair due to capital constraints. - Despite the setback, Eyenovia will focus on its two marketed products, including clobetasol propionate ophthalmic solution 0.05% for post-operative inflammation.
- Eyenovia's Phase 3 CHAPERONE study, evaluating low-dose atropine for pediatric progressive myopia, did not meet its primary endpoint. - The Data Review Committee found no significant difference in myopia progression between atropine (0.01% and 0.1%) and placebo groups. - Eyenovia plans to terminate the CHAPERONE study and is considering strategic options, including a potential business combination or asset sales. - Safety analysis indicated that all dosages of atropine were well-tolerated, with a mild adverse event profile observed during the study.
