BioLight Life Sciences (TLV:BOLT) touted data today from a Phase I/IIa clinical trial evaluating its Eye-D latanoprost insert.
The device successfully lowered intraocular pressure during the study’s 12-week period and had a favorable safety profile, according to the Israel-based company.
The latanoprost insert was designed for glaucoma patients who have trouble taking prescribed eye drops on a daily basis.
The first-in-human study compared three doses of the Eye-D latanoprost insert to once-daily eye drops in 77 glaucoma patients. The company reported that most adverse events were mild and that they didn’t observe any unanticipated adverse events.
Before treatment with the insert, mean diurnal intraocular pressure was 23.5 mmHg. After 12 weeks with the insert, participants experienced a 24% reduction in IOP. BioLight said the improvement associated with its insert was better than the results experienced with just eye drops, but did not disclose the average sustained reduction in IOP linked to the eye drops.
“Ophthalmologists today continue to struggle with finding effective solutions to the significant problem of non-adherence to the pharmaceutical treatment of patients with glaucoma,” principal investigator Dr. Howard Barnebey said in prepared remarks. “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 intra-ocular pressure lowering for three months after subconjunctival placement of the insert in human eyes, and was well tolerated,” Barnebey added. “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.”
“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,” CEO Suzana Nahum Zilberberg said. “This novel technology and its first indication, have the potential of becoming an important advance in the treatment of glaucoma patients.”
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.