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.
相关临床试验
9
0 进行中
药物批准
4
批准总数
监管机构
1
监管机构数
成立时间
2014
已完成
8
88.9%
终止
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.
