— Study will evaluate the safety and preliminary efficacy of AR-13503 SR Implant as monotherapy and in combination with aflibercept —
DURHAM, NC, USA I August 20, 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 first-in-human clinical trial of AR-13503 Sustained Release (SR) Implant in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).
This multi-arm, 24-week study (AR-13503-CS201) is being conducted in two sequential stages. The first phase is a multicenter, open label, dose escalation study of the safety and tolerability of a single intravitreal injection of AR-13503 SR Implant, using two doses, in up to 12 patients. The second phase, enrolling up to 90 patients, is a multicenter, single-masked, randomized, parallel group study of the safety and preliminary efficacy of low- or high-dose AR-13503 SR Implant, dosed as monotherapy and in combination with aflibercept (EYLEA®; Regeneron), compared to aflibercept alone. Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor approved for the treatment of retinal diseases. More information about the study is available at www.clinicaltrials.gov under the study designation NCT03835884.
“We are excited to be initiating human clinical evaluation of a novel treatment pathway for common, sight-threatening retinal diseases,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer. “Because AR-13503 may address several distinct components of the disease process in nAMD and DME, we believe the AR-13503 SR Implant has the potential to be an important addition to the treatment armamentarium in retina, particularly by helping expand the options for individualizing therapy. This study is designed to confirm our pre-clinical observations that AR-13503 could be useful as either monotherapy or in combination with VEGF inhibitors, and to help us select an appropriate dose for later stage trials. It will also provide the first clinical data for our polyesteramide bio-erodible polymer implant technology, which allows us to deliver small-molecule drugs to the back of the eye while extending treatment duration.”
About AR-13503 SR Implant
The AR-13503 SR Implant is a bio-erodible polyesteramide polymer implant that provides controlled release of AR-13503, a proprietary, small-molecule inhibitor of both Rho kinase and Protein kinase C, over a sustained period. It is designed to be administered approximately once every six months by intravitreal injection. Preclinical studies suggest that AR-13503 may inhibit angiogenesis, preserve the blood retinal barrier, and reduce retinal fibrosis in retinal diseases such as nAMD and DME, while potentially reducing the treatment burden associated with more frequent intravitreal injections.
About Retinal Disease
The retina is a thin membrane lining the back of the eye composed of highly-specialized cells that convert visible light into electrical impulses that reach the brain through the optic nerve. There are a variety of diseases, including progressive disorders such as age-related macular degeneration (AMD) and diabetic macular edema (the macula is the central portion of the retina), that can damage the retina and cause visual impairment or permanent blindness. In the United States, AMD is the leading cause of significant visual acuity loss in people over age 50 and diabetic retinopathy is the most common cause of irreversible blindness among working-age people. As a result, the retinal disease market is the largest therapeutic category in ophthalmology, with revenues in the United States reaching approximately $6.0 billion in 2018. Because current medical therapies are not adequately effective for many patients and do not stop disease progression, new treatment options are needed.
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 eye drop 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 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 was 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: 39
— Study will evaluate the safety and preliminary efficacy of AR-13503 SR Implant as monotherapy and in combination with aflibercept —
DURHAM, NC, USA I August 20, 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 first-in-human clinical trial of AR-13503 Sustained Release (SR) Implant in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).
This multi-arm, 24-week study (AR-13503-CS201) is being conducted in two sequential stages. The first phase is a multicenter, open label, dose escalation study of the safety and tolerability of a single intravitreal injection of AR-13503 SR Implant, using two doses, in up to 12 patients. The second phase, enrolling up to 90 patients, is a multicenter, single-masked, randomized, parallel group study of the safety and preliminary efficacy of low- or high-dose AR-13503 SR Implant, dosed as monotherapy and in combination with aflibercept (EYLEA®; Regeneron), compared to aflibercept alone. Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor approved for the treatment of retinal diseases. More information about the study is available at www.clinicaltrials.gov under the study designation NCT03835884.
“We are excited to be initiating human clinical evaluation of a novel treatment pathway for common, sight-threatening retinal diseases,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer. “Because AR-13503 may address several distinct components of the disease process in nAMD and DME, we believe the AR-13503 SR Implant has the potential to be an important addition to the treatment armamentarium in retina, particularly by helping expand the options for individualizing therapy. This study is designed to confirm our pre-clinical observations that AR-13503 could be useful as either monotherapy or in combination with VEGF inhibitors, and to help us select an appropriate dose for later stage trials. It will also provide the first clinical data for our polyesteramide bio-erodible polymer implant technology, which allows us to deliver small-molecule drugs to the back of the eye while extending treatment duration.”
About AR-13503 SR Implant
The AR-13503 SR Implant is a bio-erodible polyesteramide polymer implant that provides controlled release of AR-13503, a proprietary, small-molecule inhibitor of both Rho kinase and Protein kinase C, over a sustained period. It is designed to be administered approximately once every six months by intravitreal injection. Preclinical studies suggest that AR-13503 may inhibit angiogenesis, preserve the blood retinal barrier, and reduce retinal fibrosis in retinal diseases such as nAMD and DME, while potentially reducing the treatment burden associated with more frequent intravitreal injections.
About Retinal Disease
The retina is a thin membrane lining the back of the eye composed of highly-specialized cells that convert visible light into electrical impulses that reach the brain through the optic nerve. There are a variety of diseases, including progressive disorders such as age-related macular degeneration (AMD) and diabetic macular edema (the macula is the central portion of the retina), that can damage the retina and cause visual impairment or permanent blindness. In the United States, AMD is the leading cause of significant visual acuity loss in people over age 50 and diabetic retinopathy is the most common cause of irreversible blindness among working-age people. As a result, the retinal disease market is the largest therapeutic category in ophthalmology, with revenues in the United States reaching approximately $6.0 billion in 2018. Because current medical therapies are not adequately effective for many patients and do not stop disease progression, new treatment options are needed.
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 eye drop 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 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 was 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: 39
