Glaucoma Clinics Have Achieved Lasting Significant Results
Envisia Therapeutics, a clinical biotechnology company that specializes in the development of new ophthalmic sustained-release drugs, recently announced a Phase 2 clinical meta-analysis of its investigational new drug, ENV515 (travoprost XR), showing that ENV515 single-dose A clinically significant and long-lasting clinical benefit in reducing intraocular pressure (IOP) in patients with glaucoma after drug administration persisted during the first 9 months of the study and its IOP lowering effect was comparable to the other two prostaglandins used in the study Derivatives (XALATAN® and LUMIGAN®) and 0.5% timolol maleate eye drops (daily eye drops) used in the study.
Glaucoma is a group of ophthalmic diseases that cause damage to the optic nerve and decreased visual acuity, which is usually caused by abnormal fluid circulation due to poor circulation in the eye fluid, which in turn leads to abnormal changes of intraocular pressure. Hundreds of millions of people worldwide suffer from glaucoma, and the number of sick people in the United States is about 3 million. Glaucoma is the leading cause of blindness in the elderly. Glaucoma is a gradual process of disease progression, usually without obvious symptoms in the early stage, and subsequent follow-up gradually lead to visual impairment until blindness. Glaucoma blindness can be prevented by timely detection and early intervention. Glaucoma treatments include medications, lasers, and surgery. The goal of these treatments is to reduce intraocular pressure and prevent deterioration of the eye from impairing vision.
With its proprietary PRINT® technology platform, Envisia is a leader in the development of drugs to treat various eye diseases. ENV515 is a long-acting, sustained-release modified formulation of travoprost that has been marketed for glaucoma. Compared to travoprost, ENV515 further enhances the drug's properties and patient medication adherence.
In an ongoing 12-month Phase 2 clinical trial, five patients with glaucoma have been enrolled in the study. Early in the first nine months after a single low-dose ENV515 treatment, the patient's IOP at 8 AM, With an average reduction of 26% from 26.1 mmHg at the end of the elution period to 19.4 mmHg after ENV515; these patients had an intraocular pressure drop of 19.7 mmHg with XALATAN® or LUMIGAN® prior to the start of the elution period, compared with ENV515 After quite. ENV515 medication did not appear serious side effects, no abnormal changes in the cornea. Common adverse reactions for local administration caused by eye congestion.
"During the first 9 months of the study, ENV515 continued to show great potential for clinically significant and long-lasting IOP reduction with good safety," said Dr. Benjamin Yerxa, president of Envisia. "We Plans to expand the study into the group size, the end of the year will add a new cohort to assess whether the efficacy of the ENV515 high-dose drug delivery to achieve the same level of drug TRAVATAN Z®. "
"These results suggest that ENV515 may change the way we treat most glaucoma patients and have unique efficacy, safety and patient compliance in preventing progression of glaucoma," said Dr. Thomas Walters, the study's lead author .