BioLight Reports Successful Results in Phase 1/2a Clinical Trial for Glaucoma Insert
TEL-AVIV, Israel, July 24, 2017 /PRNewswire/ --
BioLight Life Sciences Ltd. (TASE: BOLT) ("BioLight"), an emerging global ophthalmic company focused on the discovery, development and commercialization of ophthalmic products and product candidates, announced today successful results from its glaucoma insert VS101 ("Eye-D latanoprost insert") Phase 1/2a clinical trial, which demonstrated its ability to lower intraocular pressure ("IOP") for a 12-week period, with a favorable safety profile.
The Eye-D latanoprost insert is designed to provide sustained IOP-lowering for patients who have difficulty taking their prescribed eye drops for the treatment of glaucoma on a continuous daily basis.
BioLight's first-in-human study, this randomized, controlled, exploratory Phase 1/2a clinical trial was designed to compare three doses of its Eye-D latanoprost inserts to once-daily latanoprost eye drops. Following a simple, in-office procedure, the sustained release Eye-D latanoprost inserts were tested for 12 weeks and compared to once-daily latanoprost eye drops for the same period.
The Phase 1/2a results comprise data from 77 glaucoma patients that were collected from 19 clinical centers across the United States. The data demonstrated that a single placement of the Eye-D latanoprost insert of one of the three doses provided the best sustained reduction in IOP throughout the 12 weeks follow up, with a positive safety profile. Highlights of the clinical trial results include:
Most adverse events were found to be mild and transient. No unanticipated adverse events were observed.
Mean diurnal IOP before treatment of patients that were treated with the effective dosed insert and completed the trial was 23.5 mmHg. A sustained reduction in IOP was observed with average diurnal IOP 17.9 mmHg at the primary endpoint of 12 weeks (5.6 mmHg, 24% reduction).
During the study, the company has gathered additional information about the procedure as well as the insert size, structure and location, which were used to improve retention rates in patient eyes.
"Ophthalmologists today continue to struggle with finding effective solutions to the significant problem of non-adherence to the pharmaceutical treatment of patients with glaucoma," said Dr. Howard Barnebey, MD, who served as a Principle Investigator in the study. "Non-adherence is a complex problem to solve. Several therapeutic approaches that aimed to address the lack of therapy compliance and persistence have either failed or are still in development."
Dr. Barnebey continued, "The Eye-D latanoprost insert has now successfully demonstrated effective intra-ocular pressure lowering for three months after subconjunctival placement of the insert in human eyes, and was well tolerated. This innovative insert presents a promising approach to improving therapeutic compliance, bypassing the issues of patients remembering to take medication as well as instilling it in their eyes. I am excited to participate in further development of Eye-D latanoprost insert."
Suzana Nahum Zilberberg, BioLight's CEO, commented, "We are very happy with the success of this clinical trial which demonstrated that the Eye-D latanoprost insert is safe and efficacious, and intend to continue our discussions with potential strategic partners, aiming to advance the development and approval process for the Eye-D latanoprost insert, while, at the same time, promoting additional steps that will assist in optimizing the treatment for glaucoma patients. This novel technology and its first indication, have the potential of becoming an important advance in the treatment of glaucoma patients". About BioLight Life Sciences Ltd.
BioLight addresses a number of significant unmet medical needs with a pipeline of ophthalmic products and product candidates, which are in various commercial and clinical stages, including: IOPtiMate™, a laser-based non-invasive surgical treatment for glaucoma; TeaRx™, a diagnostic solution that provides a multi-assay analysis of tear film constituents in order to identify one or more underlying causes of dry eye syndrome, or DES; Eye-D, an in-office insertable platform that provides for controlled release of ophthalmic medications over time; OphRx's lyotropic liquid crystals, or LLC, a non-invasive drug delivery technology administered through eye drops as an alternative to current ocular delivery modalities; and LIPITEAR™, a microemulsion consisting of Phospholipidis and Triglycerides, which forms a tear-like elastic lipid shield which is indicated for use in DES, post-operative ocular surgery (e.g. refractive surgery, cataract surgery and corneal transplant) and corneal erosions. BioLight has also invested, through Micromedic, in innovations in cancer diagnostics.
Leading key investors are Mr. Israel Makov, Chairman of Sun Pharmaceuticals, former CEO and President of Teva Pharmaceuticals and former Chairman of Given Imaging, Mr. Dilip Shanghvi, founder of Sun Pharmaceuticals, India's largest pharmaceutical company, Mr. Dan Oren, founder and CEO of Dexcel Pharma, the second-largest pharmaceutical manufacturer in Israel and Rock-One, a Hong Kong-based investment company.
For more information please visit the Company's website at http://www.bio-light.co.il