DURHAM, NC, USA I March 18, 2019 I Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye, today announced the commencement of patient dosing in a Phase 2 clinical trial of AR-1105, its investigational dexamethasone intravitreal implant, in patients with macular edema due to retinal vein occlusion (RVO).
This Phase 2 study (AR1105-CS201) will be conducted at approximately 20 centers in the United States and enroll up to 45 patients. The primary objectives of the trial are to evaluate the safety, tolerability and efficacy of the AR-1105 dexamethasone intravitreal implant. The study will be conducted in two stages. In the initial safety stage, up to 5 patients will be enrolled in a single cohort to receive clinical formulation #1 (CF-1), delivering a 340µg dose of dexamethasone in a single intravitreal injection. In Stage 2, up to 40 patients will be randomized 1:1 to receive either CF-1 or a second clinical formulation, CF-2, which delivers the same dose of dexamethasone over a longer period. Safety and efficacy will be evaluated at six months. More information about the study is available at www.clinicaltrials.gov under the study designation NCT 03739593.
“This is a proof of concept study for AR-1105 and for the retina portfolio we are building based on two enabling technologies, the bio-erodible polymers we are developing with DSM and our PRINT® manufacturing platform,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer. “The results of this trial should allow us to optimize the formulation of AR-1105 to achieve this clinical objective in Phase 3 studies. By the end of this quarter, we also plan to file an Investigational New Drug (IND) application for our second sustained delivery retina product, AR-13503 Implant, a bio-erodible implant delivering a Rho kinase/Protein kinase C inhibitor for the treatment of wet age-related macular degeneration and diabetic macular edema.”
About AR-1105
AR-1105 is a bio-erodible implant that is designed to steadily release the steroid dexamethasone over a six-month period. It is administered by intravitreal injection, a commonly-used, in-office treatment method. In addition to its six-month duration of effect, the potential benefits of AR-1105 compared to other intravitreal steroid products include improved administration with a smaller 25G needle and the potential for fewer adverse events due to lower peak drug levels. The market for retinal disease therapeutics in the United States, which is dominated by anti-VEGF agents, was approximately $6 billion in 2018. The intravitreal steroid segment represented approximately $200 million of that total.
About Aerie Pharmaceuticals, Inc.
Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye. Aerie’s first product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, a once-daily eyedrop approved by the U.S. Food and Drug Administration (FDA) for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018. In clinical trials of Rhopressa®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rhopressa®, including the product label, is available at www.rhopressa.com. Aerie’s second product for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, Rocklatan™ (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, the first and only fixed-dose combination of Rhopressa® and the widely-prescribed PGA (prostaglandin analog) latanoprost, has been approved by the FDA and is expected to be launched in the United States in the second quarter of 2019. In clinical trials of Rocklatan™ the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rocklatan™ including the product label, is available at www.rocklatan.com. Aerie continues to focus on 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.
SOURCE: Aerie Pharmaceuticals
Post Views: 148
DURHAM, NC, USA I March 18, 2019 I Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye, today announced the commencement of patient dosing in a Phase 2 clinical trial of AR-1105, its investigational dexamethasone intravitreal implant, in patients with macular edema due to retinal vein occlusion (RVO).
This Phase 2 study (AR1105-CS201) will be conducted at approximately 20 centers in the United States and enroll up to 45 patients. The primary objectives of the trial are to evaluate the safety, tolerability and efficacy of the AR-1105 dexamethasone intravitreal implant. The study will be conducted in two stages. In the initial safety stage, up to 5 patients will be enrolled in a single cohort to receive clinical formulation #1 (CF-1), delivering a 340µg dose of dexamethasone in a single intravitreal injection. In Stage 2, up to 40 patients will be randomized 1:1 to receive either CF-1 or a second clinical formulation, CF-2, which delivers the same dose of dexamethasone over a longer period. Safety and efficacy will be evaluated at six months. More information about the study is available at www.clinicaltrials.gov under the study designation NCT 03739593.
“This is a proof of concept study for AR-1105 and for the retina portfolio we are building based on two enabling technologies, the bio-erodible polymers we are developing with DSM and our PRINT® manufacturing platform,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer. “The results of this trial should allow us to optimize the formulation of AR-1105 to achieve this clinical objective in Phase 3 studies. By the end of this quarter, we also plan to file an Investigational New Drug (IND) application for our second sustained delivery retina product, AR-13503 Implant, a bio-erodible implant delivering a Rho kinase/Protein kinase C inhibitor for the treatment of wet age-related macular degeneration and diabetic macular edema.”
About AR-1105
AR-1105 is a bio-erodible implant that is designed to steadily release the steroid dexamethasone over a six-month period. It is administered by intravitreal injection, a commonly-used, in-office treatment method. In addition to its six-month duration of effect, the potential benefits of AR-1105 compared to other intravitreal steroid products include improved administration with a smaller 25G needle and the potential for fewer adverse events due to lower peak drug levels. The market for retinal disease therapeutics in the United States, which is dominated by anti-VEGF agents, was approximately $6 billion in 2018. The intravitreal steroid segment represented approximately $200 million of that total.
About Aerie Pharmaceuticals, Inc.
Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye. Aerie’s first product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, a once-daily eyedrop approved by the U.S. Food and Drug Administration (FDA) for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018. In clinical trials of Rhopressa®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rhopressa®, including the product label, is available at www.rhopressa.com. Aerie’s second product for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, Rocklatan™ (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, the first and only fixed-dose combination of Rhopressa® and the widely-prescribed PGA (prostaglandin analog) latanoprost, has been approved by the FDA and is expected to be launched in the United States in the second quarter of 2019. In clinical trials of Rocklatan™ the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rocklatan™ including the product label, is available at www.rocklatan.com. Aerie continues to focus on 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.
SOURCE: Aerie Pharmaceuticals
Post Views: 148
