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Aerie's Ophthalmic Candidate Positive in Registration Trial
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Aerie Pharmaceuticals, Inc. announced positive primary efficacy results of the 90-day phase III registration trial – Mercury 2 – for its pipeline candidate Roclatan.
We note that Aerie has outperformed the Zacks classified Medical Drugs industry in the last 12 months. The stock has rallied 144.9% during this period, compared with the industry’s 12.5% gain.
We note that Aerie is evaluating Roclatan, a once-daily, quadruple-action fixed-dose combination of its lead candidate Rhopressa and Pfizer’s (PFE - Free Report) Xalatan.
The results of the trial were consistent with the Mercury 1 trial which was a phase III registration trial that reported top-line efficacy findings in Sep 2016.
The data from the trial showed that Mercury 2 achieved its primary efficacy endpoint of demonstrating statistical superiority over each of its components – Rhopressa (netarsudil ophthalmic solution) 0.02%, and Xalatan, all of which were dosed once daily in the evening.
The data also showed that the IOP-lowering effect of Roclatan was 1 to 3 mmHg (millimeters of mercury) greater than monotherapy with either Xalatan or Rhopressa throughout the duration of the study.
The study evaluated patients with maximum baseline intraocular pressures (IOPs) ranging from above 20 to below 36 mmHg.
As a result, the company now expects to submit its NDA for Roclatan in the first half of 2018.
Moreover, the data from the trial showed relatively low discontinuation rates for the 90-day Mercury 2 trial of 9.8% and 10.6% for Roclatan and Rhopressa respectively.
The company also expects to commence a trial, Mercury 3, in mid-2017, in Europe to support filings there. The trial will be a non-inferiority trial comparing Roclatan to prescribed fixed dose combination of Ganfort (a combination of the bimatoprost along with timolol), marketed by Allergan in Europe.
Last week, Aerie announced that it has received notification from the FDA about the completion of the initial 60-day review of the NDA for Rhopressa. The FDA determined that the application is sufficiently complete and can undergo a substantive review. Concurrently, the Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s review has been set on Feb 28, 2018.
A potential approval and successful commercialization will boost the company’s growth prospects in the global ophthalmic market significantly.
VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters, with an average beat of 233.69%.
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Aerie's Ophthalmic Candidate Positive in Registration Trial
Aerie Pharmaceuticals, Inc. announced positive primary efficacy results of the 90-day phase III registration trial – Mercury 2 – for its pipeline candidate Roclatan.
We note that Aerie has outperformed the Zacks classified Medical Drugs industry in the last 12 months. The stock has rallied 144.9% during this period, compared with the industry’s 12.5% gain.
We note that Aerie is evaluating Roclatan, a once-daily, quadruple-action fixed-dose combination of its lead candidate Rhopressa and Pfizer’s (PFE - Free Report) Xalatan.
The results of the trial were consistent with the Mercury 1 trial which was a phase III registration trial that reported top-line efficacy findings in Sep 2016.
The data from the trial showed that Mercury 2 achieved its primary efficacy endpoint of demonstrating statistical superiority over each of its components – Rhopressa (netarsudil ophthalmic solution) 0.02%, and Xalatan, all of which were dosed once daily in the evening.
The data also showed that the IOP-lowering effect of Roclatan was 1 to 3 mmHg (millimeters of mercury) greater than monotherapy with either Xalatan or Rhopressa throughout the duration of the study.
The study evaluated patients with maximum baseline intraocular pressures (IOPs) ranging from above 20 to below 36 mmHg.
As a result, the company now expects to submit its NDA for Roclatan in the first half of 2018.
Moreover, the data from the trial showed relatively low discontinuation rates for the 90-day Mercury 2 trial of 9.8% and 10.6% for Roclatan and Rhopressa respectively.
The company also expects to commence a trial, Mercury 3, in mid-2017, in Europe to support filings there. The trial will be a non-inferiority trial comparing Roclatan to prescribed fixed dose combination of Ganfort (a combination of the bimatoprost along with timolol), marketed by Allergan in Europe.
Last week, Aerie announced that it has received notification from the FDA about the completion of the initial 60-day review of the NDA for Rhopressa. The FDA determined that the application is sufficiently complete and can undergo a substantive review. Concurrently, the Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s review has been set on Feb 28, 2018.
A potential approval and successful commercialization will boost the company’s growth prospects in the global ophthalmic market significantly.
Zacks Rank & Key Pick
Aerie currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the healthcare sector is VIVUS, Inc. which currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters, with an average beat of 233.69%.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana. Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look. See the pot trades we're targeting>>