Aier built the world's first glaucoma drug phase 3 clinically obtained positive data

June 14, 2018 Source: Sina Pharmaceutical

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On June 13th, multinational pharmaceutical company Allergan announced the use of Bimatoprost SR (Bemiprostin) for the treatment of intraocular pressure (IOP) in patients with open-angle glaucoma or high intraocular pressure. Data from the active top-line study of clinical trials, the treatment of this therapy belongs to the world's first in class of biodegradable beta-prostaglandin sustained-release implants. Bimatoprost SR is designed to reduce intraocular pressure for at least 4 months to achieve clinical goals while freeing patients from daily eye drops.

In a phase 3 clinical trial of the first 594 patients with open-angle glaucoma or ocular hypertension, Bimatoprost SR reduced intraocular pressure by approximately 30% during the 12-week primary efficacy period, reaching a predetermined standard. Not inferior to the control drug timolol (timolol). The initial data shows that after burying the last implant, most patients do not need treatment for a year. The reduction in intraocular pressure observed by Bimatoprost SR is similar to the reduction in intraocular pressure observed with daily topical prostaglandin analog treatment, and most patients are also well tolerated. The additional safety data for this study and the results of the second phase 3 study of the same design will be reported in the first half of 2019. It is expected that NDA documents will be submitted to the FDA in the second half of 2019.

Glaucoma is one of the main causes of irreversible vision loss and blindness. In 2010, 60.5 million people worldwide suffered from glaucoma, and this number is expected to rise to nearly 80 million by 2020. The progression of this disease is characterized by an increase in intraocular pressure. An uncontrolled increase in IOP leads to optic nerve damage and loss of vision. Lowering intraocular pressure is the only effective way to prevent glaucoma development and vision loss.

Current treatments for reducing intraocular pressure include topical medication (eye drops), laser trabeculoplasty, minimally invasive glaucoma surgery (MIGS), and incision surgery. Eye drops are the standard first-line treatment for glaucoma, but patients are less compliant with these drugs, and up to 80% of patients do not use topical drugs as prescribed. Clinically, it is often found that it is difficult for patients to adhere to eye drops every year, perhaps because they forget to use drugs, can not afford medication, do not understand their disease or can not drop eye drops and adhere to the schedule. Poor compliance with external drugs is directly related to disease progression and loss of vision. In order to eliminate long-term eye-eye compliance as a factor in protecting vision, ophthalmologists rely on laser trabeculectomy, MIGS and more invasive incision surgery, and wait for the development of sustained release drugs.

Dr. Randy Craven, Associate Professor of the Wilmer Practices Network and Associate Professor of the Johns Hopkins University School of Medicine, said: "Bimatoprost SR has the potential to be the first eye drop-free solution for patients with glaucoma. Sustained release treatment. This is a truly potential paradigm shift in reducing intraocular pressure in patients with glaucoma."

Bill Meury, chief executive of Aerjian, said: "Considering that up to 80% of glaucoma patients fail to use eye drops regularly, Bimatoprost SR has the potential to change the management of glaucoma treatment for millions of patients. Aijian's deep glaucoma assets are The introduction of Bimatoprost SR into doctors and patients provides a powerful platform." (Sina Medical Compilation / David)

Article Reference Source: Allergan Announces Positive Topline Phase 3 Clinical Data for Bimatoprost SR (Sustained-Release) Implant for IOP Lowering in Patients with Open-Angle Glaucoma or Ocular Hypertension

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