Aerie Pharmaceuticals (AERI) announced results from a double-masked, randomized, placebo-controlled study designed to evaluate the effect of its glaucoma product Rhopressa® (netarsudil ophthalmic solution) 0.02% on aqueous humor dynamics in patients with open-angle glaucoma or ocular hypertension.
This study is the first performed on glaucoma patients to confirm that Rhopressa® lowers intraocular pressure (IOP) primarily through trabecular meshwork outflow facility.
In the trials, the enrolled patients were diagnosed with open-angle glaucoma or ocular hypertension in both eyes, with a baseline IOP between 20 and 30 mmHg (millimeters of mercury) when untreated.
THE RESULTS
Rhopressa demonstrated a statistically significant increase in trabecular outflow facility of approximately 35 percent over baseline. A complete analysis of the study data will be presented at a future scientific congress.
Casey C. Kopczynski, Ph. D, Chief Scientific Officer of Aerie Pharmaceuticals stated that “Elevated IOP in open-angle glaucoma is due to dysfunction of the trabecular outflow pathway. This study confirms that in patients with elevated IOP, Rhopressa® lowers IOP by increasing trabecular outflow facility. We believe this will give physicians additional confidence that Rhopressa® targets the tissue responsible for elevated IOP in their patients, and it will help them understand their options for combining this novel trabecular outflow drug with other therapies that lower IOP through different mechanisms.”
RHOPRESSA®
Rhopressa® is a novel once-daily eye drop approved for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. A Rho kinase (ROCK) inhibitor, Rhopressa is designed to increase the outflow of aqueous humor (the fluid inside the eye) through the trabecular meshwork, the main fluid drain of the eye.
The most common adverse reactions were conjunctival hyperemia, cornea verticillata, and conjunctival hemorrhage. More information about Rhopressa®, including the full product label, is available at www.rhopressa.com.
AERIE
Aerie Pharmaceuticals is focused on the discovery, development, and commercialization of treatments for open-angle glaucoma, retinal diseases and other diseases of the eye. Rhopressa® has been approved by the FDA for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The drug was launched in the U.S. in April 2018.
PIPELINE
Roclatan™ (netarsudil/latanoprost ophthalmic solution) is a fixed-dose combination of Rhopressa and the widely-prescribed PGA (prostaglandin analog) latanoprost. In two Phase 3 registration trials, Mercury 1 and Mercury 2, Roclatan™ achieved its 3-month primary efficacy endpoint in two Phase 3 registration trials. It also showed safety and efficacy throughout 12 months in Mercury 1. Aerie submitted Roclatan New Drug Application (NDA) in May 2018 and, in July 2018, the FDA set the PDUFA date for March 14, 2019.
Aerie continues to pursue global expansion and the development of additional product candidates and technologies in ophthalmology, including for wet age-related macular degeneration and diabetic macular edema. More information is available at www.aeriepharma.com.
The Stock
Symbol: AERI
Stock Price: $64.10
Market Cap: $2.5 Billion
52-Week Stock High: $74.75
52-Week Stock Low: $47
Prohost Observations
The new study was important, as it offered proof of concept confirming that the firm’s drug mode of action as described is, indeed the cause of the lowering of the intraocular pressure in patients with open-angle glaucoma and ocular hypertension. This is important for the ophthalmologists and others who couldn’t confirm this currently confirmed reality.
Prohost picked AERI on 11/16/2016 at $41.5. The stock has almost reached our target $75, then gave back some of the gains to profit taking and to a negative market. We believe that the time has come to raise our target to $85 for two reasons: the first is the above-mentioned successful confirmatory study and the second is the catalyst coming in March 2019 in the expected approval of the firm’s second product Roclatan.
News & Comments
August 15, 2018
Aerie’s successful new confirmatory study for Rhopressa® was a necessity
Aerie Pharmaceuticals (AERI) announced results from a double-masked, randomized, placebo-controlled study designed to evaluate the effect of its glaucoma product Rhopressa® (netarsudil ophthalmic solution) 0.02% on aqueous humor dynamics in patients with open-angle glaucoma or ocular hypertension.
This study is the first performed on glaucoma patients to confirm that Rhopressa® lowers intraocular pressure (IOP) primarily through trabecular meshwork outflow facility.
In the trials, the enrolled patients were diagnosed with open-angle glaucoma or ocular hypertension in both eyes, with a baseline IOP between 20 and 30 mmHg (millimeters of mercury) when untreated.
THE RESULTS
Rhopressa demonstrated a statistically significant increase in trabecular outflow facility of approximately 35 percent over baseline. A complete analysis of the study data will be presented at a future scientific congress.
Casey C. Kopczynski, Ph. D, Chief Scientific Officer of Aerie Pharmaceuticals stated that “Elevated IOP in open-angle glaucoma is due to dysfunction of the trabecular outflow pathway. This study confirms that in patients with elevated IOP, Rhopressa® lowers IOP by increasing trabecular outflow facility. We believe this will give physicians additional confidence that Rhopressa® targets the tissue responsible for elevated IOP in their patients, and it will help them understand their options for combining this novel trabecular outflow drug with other therapies that lower IOP through different mechanisms.”
RHOPRESSA®
Rhopressa® is a novel once-daily eye drop approved for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. A Rho kinase (ROCK) inhibitor, Rhopressa is designed to increase the outflow of aqueous humor (the fluid inside the eye) through the trabecular meshwork, the main fluid drain of the eye.
The most common adverse reactions were conjunctival hyperemia, cornea verticillata, and conjunctival hemorrhage. More information about Rhopressa®, including the full product label, is available at www.rhopressa.com.
AERIE
Aerie Pharmaceuticals is focused on the discovery, development, and commercialization of treatments for open-angle glaucoma, retinal diseases and other diseases of the eye. Rhopressa® has been approved by the FDA for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The drug was launched in the U.S. in April 2018.
PIPELINE
Roclatan™ (netarsudil/latanoprost ophthalmic solution) is a fixed-dose combination of Rhopressa and the widely-prescribed PGA (prostaglandin analog) latanoprost. In two Phase 3 registration trials, Mercury 1 and Mercury 2, Roclatan™ achieved its 3-month primary efficacy endpoint in two Phase 3 registration trials. It also showed safety and efficacy throughout 12 months in Mercury 1. Aerie submitted Roclatan New Drug Application (NDA) in May 2018 and, in July 2018, the FDA set the PDUFA date for March 14, 2019.
Aerie continues to pursue global expansion and the development of additional product candidates and technologies in ophthalmology, including for wet age-related macular degeneration and diabetic macular edema. More information is available at www.aeriepharma.com.
The Stock
Symbol: AERI
Stock Price: $64.10
Market Cap: $2.5 Billion
52-Week Stock High: $74.75
52-Week Stock Low: $47
Prohost Observations
The new study was important, as it offered proof of concept confirming that the firm’s drug mode of action as described is, indeed the cause of the lowering of the intraocular pressure in patients with open-angle glaucoma and ocular hypertension. This is important for the ophthalmologists and others who couldn’t confirm this currently confirmed reality.
Prohost picked AERI on 11/16/2016 at $41.5. The stock has almost reached our target $75, then gave back some of the gains to profit taking and to a negative market. We believe that the time has come to raise our target to $85 for two reasons: the first is the above-mentioned successful confirmatory study and the second is the catalyst coming in March 2019 in the expected approval of the firm’s second product Roclatan.
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