Calgary, Alberta – TheNewswire - May 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 submission of its first-in-human (FIH) clinical study protocol for IRB approval. This development represents a critical step in the advancement of the Ocumetics Lens toward clinical trials planned for summer 2025, designed to assess safety, effectiveness, and performance of Ocumetics’ innovative lens technology in human subjects for the first time.
Dean Burns, CEO of Ocumetics, stated: “The development of our first-in-human study protocol is a major step forward and reflects our commitment to scientific rigor and patient safety. With the protocol and study endpoints now in place, we are preparing for regulatory submission and study site initiation. We are excited to move into the clinical phase of development with strong partners and a clear path forward.”
The FIH study protocol was developed in collaboration with Ocumetics’ Chief Medical Officer and a U.S.-based regulatory partner specializing in ophthalmic medical device trials. The study will evaluate overall safety, visual outcomes, accommodative functionality, and lens stability.
Dr. Doyle Stulting, Ocumetics’ Chief Medical Officer, commented: “Establishing a robust clinical protocol with well-defined endpoints is essential to ensure meaningful outcomes in a first-in-human study. We are excited to bring this novel technology forward and are confident that our study design will provide valuable insights into the lens’ potential to transform the field of vision restoration.”
With the study protocol completed, Ocumetics is currently preparing to submit its FIH study package to regulatory authorities and is working with clinical sites in anticipation of study initiation, planned for summer 2025. The Company’s goal remains steadfast: to deliver a game-changing accommodative intraocular lens that restores the eye’s natural focusing ability and offers freedom from conventional corrective lenses.
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
President and CEO
(817) 874-7564
Roger Jewett
Chief Financial Officer
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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.
