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Ocumetics Eyes First In-human Trials of Accommodating Lens Technology in Early 2024
“Biocompatibility is the entry point into the FDA process. If you do not pass the biocompatibility threshold, chances of getting an FDA approval are slim to none,” said Ocumetics Technology President and CEO Dean Burns.
Ocumetics Technology (TSXV:OTC,OTCQB:OTCFF,FWB:2QBO) has successfully completed a biocompatibility animal study for its proprietary Ocumetics Accommodating Lens, and according to President and CEO Dean Burns, the company is gearing up to commence its first in-human study for the technology in the first quarter of 2024.
“We’re going to have 15 subjects, and we’ll have the Ocumetics lens in one eye and we’ll have the control lens in the other eye, just doing a natural comparison of the effect of the lens,” he said. The in-human trials are seeking to prove the Ocumetics lens would help patients get their best-corrected vision and maximize the technology’s accommodative effects.
“We want to make sure that the patient sees extremely well. The second thing is we want to make sure that we maximize whatever the accommodative effects that we can accommodate with this technology.”
Upon completion of the first in-human study, Ocumetics will submit its US Food and Drug Administration (FDA) investigational device exemption application before proceeding with a multicenter clinical trial in the US slated for 2025, Burns explained.
Watch the full interview with Ocumetics Technology President and CEO Dean Burns above.
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