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We issued an updated research report on Aerie Pharmaceuticals, Inc. on Mar 10, 2016.
Aerie Pharmaceuticals is a development-stage company focused on the development and commercialization of eye disease therapies, including glaucoma and other eye-diseases.
Aerie's two lead product candidates – Rhopressa and Roclatan – are once-daily lowering intraocular pressure (IOP)-lowering therapies with novel mechanisms of action (MOAs) to treat patients with glaucoma or ocular hypertension.
Rhopressa, is designed to lower IOP in patients through novel MOAs. Aerie resubmitted its NDA for Rhopressa on Feb 28 and expects a standard review period of 12 months.
In Oct 2016, Aerie reported that it has withdrawn the NDA in the U.S. submitted in the third quarter of 2016. A third party manufacturing facility in Tampa, FL, not being ready for the pre-approval inspection led to the withdrawal. The contract drug product manufacturer had previously informed Aerie and the FDA that it would be prepared for the inspection in Jan 2017 but then delayed the event. The manufacturer has, however, clarified that the delay is not a result of any new finding, but the additional time needed to complete the validation of new equipment. The delay in the NDA filing was quite disappointing as Rhopressa is Aerie’s lead late-stage candidate.
Nevertheless, the company believes that Rhopressa represents the first new MOAs for lowering IOP in patients with glaucoma in over 20 years. Currently, Rhopressa is being evaluated in two phase III registration studies – the Rocket 4 study (six-month data expected in the second quarter of 2017), designed to gain adequate safety data for regulatory filings in EU and the Rocket 3 study, a 12-month, safety-only study for regulatory filings in Canada. Aerie expects to submit regulatory application for Rhopressa in the EU in the second half of 2017.
A potential approval and successful commercialization will significantly boost the company’s growth prospects in the global ophthalmic market.
Apart from Rhopressa, Aerie is evaluating Roclatan, a once-daily, quadruple-action fixed-dose combination of Rhopressa and Pfizer’s (PFE - Free Report) Xalatan (latanoprost). Roclatan is currently in a phase III registration studies – Mercury 1 (12-month top line safety data expected in third-quarter of 2017) and Mercury 2 (top-line 90-day data expected in the second quarter of 2017). Both studies are designed to demonstrate the superiority of the candidate over each of its components. Based on the success of the Mercury 1 and Mercury 2, the company plans to file a NDA for Roclatan by the end of 2017 or early 2018.
On the other hand, the company plans to initiate a third phase III study, Mercury 3, on Roclatan later in 2017 to facilitate its regulatory approval and commercialization in Europe. The study is designed to compare the candidate to a fixed-dose combination product that is marketed in the EU.
However, Aerie faces stiff competition from established branded and generic pharmaceutical companies, such as Novartis' (NVS - Free Report) Simbrinza and Travtan, and Allergan’s Lumigan, as well as other smaller biotechnology and pharmaceutical companies.
We expect investors to remain focussed on further updates on Rhopressa by the NDA in 2017.
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Aerie Resubmits Rhopressa NDA, Roclatan Gains Traction
We issued an updated research report on Aerie Pharmaceuticals, Inc. on Mar 10, 2016.
Aerie Pharmaceuticals is a development-stage company focused on the development and commercialization of eye disease therapies, including glaucoma and other eye-diseases.
Aerie's two lead product candidates – Rhopressa and Roclatan – are once-daily lowering intraocular pressure (IOP)-lowering therapies with novel mechanisms of action (MOAs) to treat patients with glaucoma or ocular hypertension.
Rhopressa, is designed to lower IOP in patients through novel MOAs. Aerie resubmitted its NDA for Rhopressa on Feb 28 and expects a standard review period of 12 months.
In Oct 2016, Aerie reported that it has withdrawn the NDA in the U.S. submitted in the third quarter of 2016. A third party manufacturing facility in Tampa, FL, not being ready for the pre-approval inspection led to the withdrawal. The contract drug product manufacturer had previously informed Aerie and the FDA that it would be prepared for the inspection in Jan 2017 but then delayed the event. The manufacturer has, however, clarified that the delay is not a result of any new finding, but the additional time needed to complete the validation of new equipment. The delay in the NDA filing was quite disappointing as Rhopressa is Aerie’s lead late-stage candidate.
Nevertheless, the company believes that Rhopressa represents the first new MOAs for lowering IOP in patients with glaucoma in over 20 years. Currently, Rhopressa is being evaluated in two phase III registration studies – the Rocket 4 study (six-month data expected in the second quarter of 2017), designed to gain adequate safety data for regulatory filings in EU and the Rocket 3 study, a 12-month, safety-only study for regulatory filings in Canada. Aerie expects to submit regulatory application for Rhopressa in the EU in the second half of 2017.
A potential approval and successful commercialization will significantly boost the company’s growth prospects in the global ophthalmic market.
Apart from Rhopressa, Aerie is evaluating Roclatan, a once-daily, quadruple-action fixed-dose combination of Rhopressa and Pfizer’s (PFE - Free Report) Xalatan (latanoprost). Roclatan is currently in a phase III registration studies – Mercury 1 (12-month top line safety data expected in third-quarter of 2017) and Mercury 2 (top-line 90-day data expected in the second quarter of 2017). Both studies are designed to demonstrate the superiority of the candidate over each of its components. Based on the success of the Mercury 1 and Mercury 2, the company plans to file a NDA for Roclatan by the end of 2017 or early 2018.
On the other hand, the company plans to initiate a third phase III study, Mercury 3, on Roclatan later in 2017 to facilitate its regulatory approval and commercialization in Europe. The study is designed to compare the candidate to a fixed-dose combination product that is marketed in the EU.
However, Aerie faces stiff competition from established branded and generic pharmaceutical companies, such as Novartis' (NVS - Free Report) Simbrinza and Travtan, and Allergan’s Lumigan, as well as other smaller biotechnology and pharmaceutical companies.
We expect investors to remain focussed on further updates on Rhopressa by the NDA in 2017.
5 Trades Could Profit ""Big-League"" from Trump Policies
If the stocks above spark your interest, wait until you look into companies primed to make substantial gains from Washington's changing course.
Today Zacks reveals 5 tickers that could benefit from new trends like streamlined drug approvals, tariffs, lower taxes, higher interest rates, and spending surges in defense and infrastructure. See these buy recommendations now >>