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Eyenovia Initiates Phase III Study for Mydriasis Candidate
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Eyenovia, Inc. (EYEN - Free Report) announced that it has initiated enrollment of patients in a phase III study – MIST-1 – to evaluate MicroStat as a treatment for pharmacologic mydriasis (dilation of the pupil). The study is part of a program that includes two pivotal phase III studies – MIST-1 and MIST-2 – for evaluating MicroStat, a fixed-combination phenylephrine (2.5%) and tropicamide (1%) ophthalmic solution administered as micro-dose through Optejet dispenser.
The company expects to announce top-line data from both the studies in the first half of 2019.
Eyenovia’s stock rallied 30.7% in after-market trading on Nov 26 following the news. However, the company’s shares have declined 71% so far this year compared with the industry’s decline of 19.6%.
The MIST-1 study will administer MicroStat combination solution and each component of the solution in both eyes of patients on separate days while the MIST-2 study will administer MicroStat and a placebo in patients on separate days. The primary endpoint of both the studies is the mean change in pupil diameter at 35 minutes after administration from baseline.
Per the press release, pharmacologic mydriasis is an important part of office-based comprehensive and diabetic eye exams conducted every year in the United States. It is essential for the standard dilated retinal fundoscopic examination. An estimated 80 million such exams are performed every year in the country. This represents significant opportunity for the candidate.
Eyenovia has another late-stage ready candidate, MicroProst, in its pipeline, which is being developed for the treatment of chronic angle closure glaucoma. The company plans to initiate a phase III study to evaluate the candidate in the first half of 2019.
The company also has an over-the-counter product candidate, MicroTears, for treating dry eye. The candidate does not require evaluation in a phase III study and the company will start registration activities soon.
Gilead’s earnings estimates have increased from $6.60 to $6.93 for 2018 and from $6.53 to $6.83 for 2019 over the past 60 days. The company delivered positive earnings surprise in three of the four trailing quarters with the average beat being 6.99%.
Alexion’s earnings estimates have moved up from $7.23 to $7.61 for 2018 and from $8.59 to $8.77 for 2019 over the past 60 days. The company came up with a positive earnings surprise in all the four trailing quarters with the average beat being 16.77%.
NeoGenomics’ earnings per share estimates have increased from 15 cents to 18 cents for 2018 and 21 cents to 24 cents for 2019 over the past 60 days. The company delivered a positive surprise in all the four trailing quarters with the average beat being 37.5%. The stock is up 85.9% so far this year.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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Eyenovia Initiates Phase III Study for Mydriasis Candidate
Eyenovia, Inc. (EYEN - Free Report) announced that it has initiated enrollment of patients in a phase III study – MIST-1 – to evaluate MicroStat as a treatment for pharmacologic mydriasis (dilation of the pupil). The study is part of a program that includes two pivotal phase III studies – MIST-1 and MIST-2 – for evaluating MicroStat, a fixed-combination phenylephrine (2.5%) and tropicamide (1%) ophthalmic solution administered as micro-dose through Optejet dispenser.
The company expects to announce top-line data from both the studies in the first half of 2019.
Eyenovia’s stock rallied 30.7% in after-market trading on Nov 26 following the news. However, the company’s shares have declined 71% so far this year compared with the industry’s decline of 19.6%.
The MIST-1 study will administer MicroStat combination solution and each component of the solution in both eyes of patients on separate days while the MIST-2 study will administer MicroStat and a placebo in patients on separate days. The primary endpoint of both the studies is the mean change in pupil diameter at 35 minutes after administration from baseline.
Per the press release, pharmacologic mydriasis is an important part of office-based comprehensive and diabetic eye exams conducted every year in the United States. It is essential for the standard dilated retinal fundoscopic examination. An estimated 80 million such exams are performed every year in the country. This represents significant opportunity for the candidate.
Eyenovia has another late-stage ready candidate, MicroProst, in its pipeline, which is being developed for the treatment of chronic angle closure glaucoma. The company plans to initiate a phase III study to evaluate the candidate in the first half of 2019.
The company also has an over-the-counter product candidate, MicroTears, for treating dry eye. The candidate does not require evaluation in a phase III study and the company will start registration activities soon.
Eyenovia, Inc. Price
Eyenovia, Inc. Price | Eyenovia, Inc. Quote
Zacks Rank & Stock to Consider
Eyenovia carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the pharma sector include Gilead Sciences, Inc. (GILD - Free Report) , Alexion Pharmaceuticals, Inc. and NeoGenomics, Inc. (NEO - Free Report) . All the three stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings estimates have increased from $6.60 to $6.93 for 2018 and from $6.53 to $6.83 for 2019 over the past 60 days. The company delivered positive earnings surprise in three of the four trailing quarters with the average beat being 6.99%.
Alexion’s earnings estimates have moved up from $7.23 to $7.61 for 2018 and from $8.59 to $8.77 for 2019 over the past 60 days. The company came up with a positive earnings surprise in all the four trailing quarters with the average beat being 16.77%.
NeoGenomics’ earnings per share estimates have increased from 15 cents to 18 cents for 2018 and 21 cents to 24 cents for 2019 over the past 60 days. The company delivered a positive surprise in all the four trailing quarters with the average beat being 37.5%. The stock is up 85.9% so far this year.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>