Today marks a defining moment in the history of Ocumetics—and in the future of vision restoration worldwide.
It is with great pride and anticipation that I share we are now entering the final stages before our First-In-Human (FIH) clinical study for the Ocumetics Lens. This is more than a corporate milestone; it is the beginning of a new chapter in medical innovation. For the first time, our revolutionary accommodating intraocular lens is preparing to be implanted in human subjects.
This is historic.
Years of tireless research, engineering, and regulatory preparation have brought us to this pivotal point. Our team has worked diligently to ensure that every element of the development process has met the highest standards of safety, efficacy, and precision. From the successful demonstration of accommodative power to the production of optimized, design-locked lenses, each step has validated the immense potential of the Ocumetics Lens.
We remain on track to begin surgeries this summer. This is not just the culmination of our efforts—it is the true beginning of what we set out to accomplish. Following the procedures, we will begin a 12-month post-operative monitoring period and prepare for the next critical phase: submitting to the FDA for pivotal clinical trials, anticipated to begin in 2026.
This achievement belongs to all of us—our team, our partners, and especially you, our shareholders. Your continued belief in our mission has made this milestone possible.
As we stand on the threshold of transforming how cataracts are treated and how natural vision is restored, I want to personally thank you for your support.
We are not just witnessing history. We are making it.
Best regards,
Dean Burns
President, CEO, and Director
Ocumetics Technology Corp.
Many of the questions we receive from investors relate to the process for obtaining US Food and Drug Administration (FDA) approval for surgical devices, such as the Ocumetics Accommodating Lens. This month’s message is focused on outlining how the process works and unpacking the steps required to obtain FDA approval. You will be thrilled to
Imagine a world in which glasses and traditional contact lenses become obsolete, and natural vision is restored with a simple and innovative solution.
That's precisely what we aim to achieve with the Ocumetics Accommodating Lens technology (“Ocumetics Accommodating Lens”).
