BioLight Life Sciences announced successful results from its glaucoma insert VS101 (Eye-D latanoprost insert) phase 1/2a clinical trial, which demonstrated its ability to lower IOP for a 12-week period, with a favorable safety profile, according to a company news release.
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," Howard Barnebey, MD, who served as a principle investigator in the study, said in the news release. "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."
"The Eye-D latanoprost insert has now successfully demonstrated effective intraocular pressure lowering for three months after subconjunctival placement of the insert in human eyes, and was well tolerated," Dr. Barnebey said. "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".