Ocumetics begins patient recruitment for FIH lens study

Executive Summary

• Ocumetics Technology Corp. has commenced patient recruitment for its first-in-human (FIH) clinical study of the Ocumetics accommodating intraocular lens.
• Patient recruitment is expected to be completed within approximately seven days.
• The study aims to assess the safety of the lens, evaluate surgical technique, and measure distance acuity and accommodative effects, serving as a critical step toward regulatory approval and market launch.

Key Details

• Study Phase: First-in-human (FIH) clinical study.
• Product: Ocumetics accommodating intraocular lens, designed to change power in response to the brain's visual demands, unlike traditional monofocal or multifocal lenses.
• Recruitment Status: Commenced; expected completion in ~7 days.
• Location: Clinical partner site in Mexico City.
• Study Objectives:
  • Primary: Assess safety of the Ocumetics Lens.
  • Secondary: Evaluate surgical technique, distance acuity, and accommodative effects.
• Next Steps: Implantations will begin after patient recruitment, final site inspection, and surgeon training are completed.
• Strategic Importance: Results will be instrumental in obtaining regulatory approval for larger, future studies and bringing the lens to market.

Notable Quotes

• "We are thrilled to begin recruiting patients for this historic study at our clinical partner site in Mexico City... This is another significant step toward our goal of restoring clear distance and near vision without glasses after cataract surgery." — Dean Burns, President and CEO