Calgary, Alberta – TheNewswire - April 22, 2025 - Ocumetics Technology Corp. (“Ocumetics” or the “Company”) (TSXV: OTC) (OTCQB: OTCFF) (FRA: 2QBO), a leader in advanced ophthalmic technology, is pleased to announce the achievement of several key milestones paving the way for its First-In-Human (“FIH”) clinical study of the Company’s innovative accommodating intraocular lens (the “Ocumetics Lens”).

“Advancing a medical device like the Ocumetics Lens from concept to First-In-Human evaluation requires a rigorous, structured process to ensure safety, efficacy, and full regulatory compliance,” said Dean Burns, President and CEO of Ocumetics.

“With the recent completion of numerous critical advancements, we’re excited to share our roadmap toward FIH clinical trials, which are set to begin in the coming months,” adds Burns. “The FIH surgery and Initial study results are expected this summer, with full results anticipated in the fall. We also expect to submit an application to the FDA in early 2026 for pivotal clinical trials, with a target start date in 2026.”

Final Preparations Leading to First-In-Human Surgery

The final stages leading up to the landmark FIH procedure are well underway, with the following critical steps:

• Demonstration of accommodative power: Laboratory testing to confirm adequate accommodative power using moulded lenses. 

• Manufacture and test optimized, design-locked lenses: Production and quality assurance of Ocumetics Lenses to ensure consistency for the FIH study. 

• Engage clinical site and surgeon: Finalize agreements with the clinical study site and select a qualified surgeon for implantation procedures. 

• Submit FIH study application: Prepare and submit a comprehensive application for regulatory approval. 

• Secure regulatory clearance: Obtain all necessary approvals to move forward with the FIH study. 

• Patient recruitment: Identify and recruit a diverse, representative patient population. 

• Conduct surgeries: Perform lens implantation surgeries on selected participants. 

Post-Operative Monitoring and Regulatory Reporting

Following the FIH surgeries, Ocumetics will conduct extensive post-operative analysis as part of the regulatory process:

1. Twelve-month follow-up: The Ocumetics medical team will monitor patients over a 12-month period to evaluate safety and efficacy. 

2. Clinical trial reporting: Interim and final results will be compiled into comprehensive reports and submitted to regulatory bodies for review. 

Dr. Garth Webb, founder and Chief Scientific Officer of Ocumetics, stated, “Our team has worked tirelessly to reach this point, and we are confident the FIH study will showcase the transformative potential of our accommodating intraocular lens. We believe this technology can redefine vision restoration for cataract patients and pave the way to restoring natural, clear vision for millions worldwide.”

About Ocumetics

 

Ocumetics Technology Corp. (TSXV: OTC) (OTCQB: OTCFF) (FRA: 2QBO) is a Canadian research and product development company that is dedicated to developing advanced vision correction solutions that enhance the quality of life for patients. Through innovative research and development, Ocumetics aims to transform the field of ophthalmology with state-of-the-art intraocular lenses and other vision-enhancing technologies.

 

Ocumetics is in the preclinical study stage of a game-changing technology for the ophthalmic industry.  Ocumetics has developed an intraocular lens that fits within the natural lens compartment of the eye potentially to eliminate the need for corrective lenses.  It is designed to allow the eye’s natural muscle activity to shift focus from distance to near, providing clear vision at all distances without the help of glasses or contact lenses.  

 

FOR FURTHER INFORMATION, PLEASE CONTACT:

 

Dean Burns                                Roger Jewett

President and CEO                        Chief Financial Officer

(817) 874-7564                                roger.jewett@ocumetics.com

 

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This news release includes certain “forward-looking statements” under applicable Canadian securities legislation.  Forward-looking statements include, but are not limited to, statements with respect to the commencement, timing and scope of the research and development to be conducted by the Corporation mentioned above.  Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include but are not limited to: operational matters, historical trends, current conditions and expected future developments, access to financing as well as other considerations that are believed to be appropriate in the circumstances.  There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements.  The Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.