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Earnings
Eyenovia reports Q3 EPS (21c), consensus (23c) » 16:12
11/10/21
11/10
16:12
11/10/21
16:12
EYEN

Eyenovia

$3.94 /

-0.08 (-1.99%)

As of September 30, the…

As of September 30, the company's unrestricted and restricted cash balance was approximately $21.4M. "As of today, we believe we are sufficiently capitalized with approximately $30M in unrestricted and restricted cash to cover the company's planned expenses for Mydcombi, MicroLine and MicroPine throughout 2022. In addition, we look forward to delivering potentially value creating milestones in 2022 and into 2023," CEO Sean Ianchulev said.

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EYEN Eyenovia
$3.94 /

-0.08 (-1.99%)

EYEN Eyenovia
$3.94 /

-0.08 (-1.99%)

10/26/21 Northland
Eyenovia price target lowered to $9 from $12 at Northland
04/01/21 H.C. Wainwright
Eyenovia price target raised to $8 from $6 at H.C. Wainwright
03/01/21 Northland
Eyenovia initiated with an Outperform at Northland
12/30/20 H.C. Wainwright
H.C. Wainwright reiterates $6 target on Eyenovia after new drug submission
EYEN Eyenovia
$3.94 /

-0.08 (-1.99%)

Over a month ago
Hot Stocks
Eyenovia announces first patient enrolled in Phase 3 VISION-2 trial » 08:38
11/04/21
11/04
08:38
11/04/21
08:38
EYEN

Eyenovia

$4.00 /

-0.005 (-0.13%)

Eyenovia announced that…

Eyenovia announced that the first patient has been enrolled in the Company's second Phase 3 clinical trial of MicroLine, its proprietary pilocarpine formulation for temporary improvement in near vision, known as VISION-2. "Following the completion of VISION-1 study, we are pleased to initiate this second Phase 3 trial that, if successful, will contribute to the clinical evidence supporting a new drug/device combination application to the US FDA," stated Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. "By leveraging the numerous benefits of our microdose array print technology, we believe MicroLine has the potential to be among the first drug treatments to improve blurred near vision that can adversely impact quality of life in patients with presbyopia." The VISION-2 study is a double-masked, placebo-controlled, cross-over superiority trial in which approximately 140 subjects with presbyopia will be treated. During the study, subjects will be randomly assigned to a treatment sequence for dosing with pilocarpine 2% as well as placebo, both administered via the Optejet dispenser. The primary endpoint is improvement in high contrast binocular distance corrected near visual acuity measured in low light conditions 2 hours after treatment. Topline data is expected in mid-2022.

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EYEN Eyenovia
$4.00 /

-0.005 (-0.13%)

EYEN Eyenovia
$4.00 /

-0.005 (-0.13%)

10/26/21 Northland
Eyenovia price target lowered to $9 from $12 at Northland
04/01/21 H.C. Wainwright
Eyenovia price target raised to $8 from $6 at H.C. Wainwright
03/01/21 Northland
Eyenovia initiated with an Outperform at Northland
12/30/20 H.C. Wainwright
H.C. Wainwright reiterates $6 target on Eyenovia after new drug submission
EYEN Eyenovia
$4.00 /

-0.005 (-0.13%)

Recommendations
Eyenovia price target lowered to $9 from $12 at Northland » 08:09
10/26/21
10/26
08:09
10/26/21
08:09
EYEN

Eyenovia

$4.02 /

-2.585 (-39.17%)

Northland analyst Tim…

Northland analyst Tim Chiang lowered the firm's price target on Eyenovia to $9 from $12 and keeps an Outperform rating on the shares after the company's receipt of an FDA Complete Response Letter for MydCombi, which he calls "a mild setback." The CRL pushes out a potential approval for MydCombi to mid-2022, but after discussions management, Chiang noted that they said a significant amount of the work has already been performed and that the FDA did not cite any issues with the Phase 3 clinical studies, which could cut down the amount of time required for refiling of the company's NDA.

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EYEN Eyenovia
$4.02 /

-2.585 (-39.17%)

EYEN Eyenovia
$4.02 /

-2.585 (-39.17%)

04/01/21 H.C. Wainwright
Eyenovia price target raised to $8 from $6 at H.C. Wainwright
03/01/21 Northland
Eyenovia initiated with an Outperform at Northland
12/30/20 H.C. Wainwright
H.C. Wainwright reiterates $6 target on Eyenovia after new drug submission
EYEN Eyenovia
$4.02 /

-2.585 (-39.17%)

Hot Stocks
Eyenovia announces FDA reclassification of MydCombi » 08:09
10/25/21
10/25
08:09
10/25/21
08:09
EYEN

Eyenovia

$6.61 /

+0.65 (+10.91%)

Eyenovia announced that…

Eyenovia announced that MydCombi, the company's proprietarycombination microdose formulation of tropicamide and phenylephrine for in-office pupil dilation, has been reclassified as a drug-device combination product by the U.S. Food and Drug Administration in a Complete Response Letter for the company's new drug application received on October 22, 2021. Eyenovia will provide additional information to the FDA, as requested in the CRL, as soon as possible, including information necessary to meet additional requirements under Genus Medical Technologies, LLC v. FDA. Genus refers to a recent decision by the U.S. Court of Appeals for the District of Columbia Circuit which has resulted in an agency-wide reclassification by FDA of certain drugs to devices or to drug-device combination products. There were no issues raised related to the phase III clinical program for MydCombi. "While we were surprised by the FDA's position in the CRL, given our original FDA designation, we understand the unusual situation created by the impact of the Genus case, which compelled an Agency-wide reclassification," stated Dr. Sean Ianchulev, CEO and CMO of Eyenovia. "Fortunately, we had taken actions throughout the development of MydCombi to minimize the impact of a potential reclassification by the FDA. We are preparing additional documentation requested by the FDA and look forward to resubmitting our NDA in early 2022 for the FDA's review. Since the device used for MydCombi has commonality with that used in the MicroLine and MicroPine programs, we believe that the information submitted in support of MydCombi will pave the way in advance of those regulatory submissions. In fact, we are on track to initiate our second Phase III MicroLine study for presbyopia in the coming days." The Company's current total pro forma cash balance is approximately $30.7 million after the sale of approximately 1.8 million shares of common stock earlier this quarter through the Company's At The Market offering facility. The Company believes its total unrestricted and restricted cash balance will be sufficient for the resubmission of the NDA for MydCombi, completion of the MicroLine clinical program and other planned activities through the beginning of 2023. Eyenovia announced FDA acceptance of the MydCombi NDA in March 2021. The NDA was based on the MIST-1 and MIST-2 studies. In these two Phase 3 studies, a fixed combination of micro-dosed tropicamide 1% and phenylephrine 2.5% ophthalmic solution met the studies' primary endpoints and was shown to be well-tolerated and effective for pharmacologic mydriasis. Approximately 94% of treated eyes achieved 6mm or greater dilation at 35 minutes post-instillation. Adverse events were infrequent, with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain.

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EYEN Eyenovia
$6.61 /

+0.65 (+10.91%)

EYEN Eyenovia
$6.61 /

+0.65 (+10.91%)

04/01/21 H.C. Wainwright
Eyenovia price target raised to $8 from $6 at H.C. Wainwright
03/01/21 Northland
Eyenovia initiated with an Outperform at Northland
12/30/20 H.C. Wainwright
H.C. Wainwright reiterates $6 target on Eyenovia after new drug submission
EYEN Eyenovia
$6.61 /

+0.65 (+10.91%)

Hot Stocks
Arctic Vision, Eyenovia to partner on MydCombi commercialization in China, Korea » 20:18
09/16/21
09/16
20:18
09/16/21
20:18
EYEN

Eyenovia

$4.45 /

+ (+0.00%)

Arctic Vision announced…

Arctic Vision announced that it will expand its exclusive license agreement with Eyenovia to include a third asset, MydCombi, for development and commercialization in Greater China and South Korea. MydCombi is Eyenovia's proprietary, first-in-class combination microdose formulation of tropicamide and phenylephrine for mydriasis. MydCombi was developed leveraging the Optejet dispenser, Eyenovia's proprietary microdose array print formulation and delivery platform, to ensure consistent and easy application of two mydriatic medications in a quick, high-precision, and touchless, micro-mist application. In August 2020, Arctic Vision entered into an exclusive license with Eyenovia for the development and commercialization of ARVN002 for treatment of paediatric progressive myopia and ARVN003 for presbyopia treatment in Greater China and South Korea. In China, IND applications for Phase III studies of ARVN002 and ARVN003 have both been cleared.

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EYEN Eyenovia
$4.45 /

+ (+0.00%)

EYEN Eyenovia
$4.45 /

+ (+0.00%)

04/01/21 H.C. Wainwright
Eyenovia price target raised to $8 from $6 at H.C. Wainwright
03/01/21 Northland
Eyenovia initiated with an Outperform at Northland
12/30/20 H.C. Wainwright
H.C. Wainwright reiterates $6 target on Eyenovia after new drug submission
10/23/20 H.C. Wainwright
Eyenovia price target lowered to $6 from $7 at H.C. Wainwright
EYEN Eyenovia
$4.45 /

+ (+0.00%)

Over a quarter ago
Hot Stocks
Eyenovia provides update on three Phase 3 programs » 08:10
06/15/21
06/15
08:10
06/15/21
08:10
EYEN

Eyenovia

$5.47 /

+0.03 (+0.55%)

Eyenovia provided a…

Eyenovia provided a corporate update on its pipeline with recent and upcoming milestones. Eyenovia previously announced initial topline data from its Phase 3 VISION-1 clinical trial. Today, the company is providing additional details from the study. The VISION-1 study evaluated the safety and efficacy of Eyenovia's MicroLine presbyopia microdose formulations versus placebo, all administered via the company's proprietary Optejet delivery Micro-Array Print technology. Key highlights from the 2% MicroLine dose include: a higher proportion of subjects met the primary endpoint of 3-line or greater improvement in near vision with 2% MicroLine as compared to placebo; a higher proportion of subjects achieved 2-line or greater improvement in near vision with 2% MicroLine as compared to placebo; 71% of patients reported a meaningful improvement in near vision according to an exit survey conducted by study investigators; all ocular AEs were trace to mild in severity and transient in nature. Importantly, fewer than 3% of study participants reported headache and brow ache. To support the submission of a New Drug Application, the company is on track to initiate a second Phase 3 registrational trial, VISION-2, later this year. VISION-2 will be a double-masked, placebo-controlled, cross-over superiority trial designed to enroll 120 patients randomized between 2% pilocarpine and placebo cohorts. Topline data is anticipated in mid-2022. Eyenovia is developing MydCombi for pharmacologic mydriasis. In March 2021, the FDA accepted Eyenovia's NDA, which was supported by two successful Phase 3 studies, MIST-1 and MIST-2. FDA has assigned a PDUFA target action date of October 28, 2021. If approved, Eyenovia anticipates marketing MydCombi with a small, targeted sales force. The company has also partnered with EVERSANA, a leading provider of commercial services to the global life sciences industry, to assist with the launch. Eyenovia previously disclosed two licensing agreements for its investigational treatment for the reduction of pediatric myopia progression, MicroPine: with Arctic Vision for Greater China and Korea, and Bausch Health for the United States and Canada.

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EYEN Eyenovia
$5.47 /

+0.03 (+0.55%)

EYEN Eyenovia
$5.47 /

+0.03 (+0.55%)

04/01/21 H.C. Wainwright
Eyenovia price target raised to $8 from $6 at H.C. Wainwright
03/01/21 Northland
Eyenovia initiated with an Outperform at Northland
12/30/20 H.C. Wainwright
H.C. Wainwright reiterates $6 target on Eyenovia after new drug submission
10/23/20 H.C. Wainwright
Eyenovia price target lowered to $6 from $7 at H.C. Wainwright
EYEN Eyenovia
$5.47 /

+0.03 (+0.55%)

  • 19
    Aug
Conference/Events
Eyenovia management to meet virtually with Northland » 04:55
06/09/21
06/09
04:55
06/09/21
04:55
EYEN

Eyenovia

$5.42 /

+0.06 (+1.12%)

Virtual Meeting to be…

Virtual Meeting to be held on June 9 hosted by Northland.

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EYEN Eyenovia
$5.42 /

+0.06 (+1.12%)

EYEN Eyenovia
$5.42 /

+0.06 (+1.12%)

04/01/21 H.C. Wainwright
Eyenovia price target raised to $8 from $6 at H.C. Wainwright
03/01/21 Northland
Eyenovia initiated with an Outperform at Northland
12/30/20 H.C. Wainwright
H.C. Wainwright reiterates $6 target on Eyenovia after new drug submission
10/23/20 H.C. Wainwright
Eyenovia price target lowered to $6 from $7 at H.C. Wainwright
EYEN Eyenovia
$5.42 /

+0.06 (+1.12%)

  • 19
    Aug
Conference/Events
Eyenovia management to meet virtually with Northland » 11:52
06/08/21
06/08
11:52
06/08/21
11:52
EYEN

Eyenovia

$5.34 /

-0.02 (-0.37%)

Virtual Meeting to be…

Virtual Meeting to be held on June 9 hosted by Northland.

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EYEN Eyenovia
$5.34 /

-0.02 (-0.37%)

EYEN Eyenovia
$5.34 /

-0.02 (-0.37%)

04/01/21 H.C. Wainwright
Eyenovia price target raised to $8 from $6 at H.C. Wainwright
03/01/21 Northland
Eyenovia initiated with an Outperform at Northland
12/30/20 H.C. Wainwright
H.C. Wainwright reiterates $6 target on Eyenovia after new drug submission
10/23/20 H.C. Wainwright
Eyenovia price target lowered to $6 from $7 at H.C. Wainwright
EYEN Eyenovia
$5.34 /

-0.02 (-0.37%)

  • 19
    Aug
Hot Stocks
Eyenovia says primary endpoint achieved in VISION-1 Phase 3 study » 09:10
05/25/21
05/25
09:10
05/25/21
09:10
EYEN

Eyenovia

$4.67 /

-0.18 (-3.71%)

Eyenovia announced that…

Eyenovia announced that its VISION-1 study evaluating the company's proprietary pilocarpine formulation, MicroLine, for the temporary improvement of near vision in adults with presbyopia, achieved its primary endpoint. Preparations are underway for a second Phase 3 registration study, VISION-2. These studies are required for FDA approval and will serve as the basis for a planned New Drug Application submission to FDA. VISION-1 results will be presented at a future ophthalmic-focused medical meeting. The VISION-1 study evaluated the safety and efficacy of Eyenovia's 1% and 2% pilocarpine Micro-Array Print formulations versus placebo, all administered via the company's proprietary Optejet dispenser. VISION-1 is the third Phase 3 study demonstrating the utility of the company's MAP technology in improving the therapeutic index of topical ophthalmic drugs. Key highlights from the study include: VISION-1 met its primary endpoint with a statistically significant proportion of subjects treated with a therapeutic dose of MicroLine showing a three-line or more improvement in distance corrected near visual acuity versus placebo in low light conditions at two hours post-treatment. MicroLine was very well tolerated. Adverse events were all mild in nature and there were no serious adverse events. In a post-study survey, 70% of study participants reported strong interest in using MicroLine for near vision improvement should it be approved. These patients said they would expect to use the product three to four times per week on average.

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EYEN Eyenovia
$4.67 /

-0.18 (-3.71%)

EYEN Eyenovia
$4.67 /

-0.18 (-3.71%)

04/01/21 H.C. Wainwright
Eyenovia price target raised to $8 from $6 at H.C. Wainwright
03/01/21 Northland
Eyenovia initiated with an Outperform at Northland
12/30/20 H.C. Wainwright
H.C. Wainwright reiterates $6 target on Eyenovia after new drug submission
10/23/20 H.C. Wainwright
Eyenovia price target lowered to $6 from $7 at H.C. Wainwright
EYEN Eyenovia
$4.67 /

-0.18 (-3.71%)

  • 19
    Aug
Earnings
Eyenovia reports Q1 EPS (21c), consensus (22c) » 16:39
05/12/21
05/12
16:39
05/12/21
16:39
EYEN

Eyenovia

$4.57 /

-0.21 (-4.39%)

As of March 31, the…

As of March 31, the company's cash balance was approximately $24.9M. Sean Ianchulev, CEO and CMO of Eyenovia, commented, "The Eyenovia team has made substantial progress in advancing towards its clinical, regulatory, and commercial goals during the first quarter of 2021. We look forward to our PDUFA date for MydCombi on October 28th of this year. In preparation for the anticipated approval, we were pleased to announce an exclusive agreement with EVERSANA to help lead distribution of MydCombi in the United States. If approved, MydCombi would be the first microdosed ocular therapeutic applied with our proprietary high precision smart delivery system, the Optejet(R)."

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EYEN Eyenovia
$4.57 /

-0.21 (-4.39%)

EYEN Eyenovia
$4.57 /

-0.21 (-4.39%)

04/01/21 H.C. Wainwright
Eyenovia price target raised to $8 from $6 at H.C. Wainwright
03/01/21 Northland
Eyenovia initiated with an Outperform at Northland
12/30/20 H.C. Wainwright
H.C. Wainwright reiterates $6 target on Eyenovia after new drug submission
10/23/20 H.C. Wainwright
Eyenovia price target lowered to $6 from $7 at H.C. Wainwright
EYEN Eyenovia
$4.57 /

-0.21 (-4.39%)

  • 19
    Aug
EYEN Eyenovia
$4.57 /

-0.21 (-4.39%)

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