Omega Ophthalmics LLC has closed on $7 million in Series A financing as it moves forward in advancing the clinical development of a novel intraocular lens (IOL) platform for cataract surgery.
Let’s start with this company.
Operating out of Lexington, Kentucky, the venture-backed medical technology company was established in 2012 with one key clinical focus: utilizing augmented reality (AR) to develop surgically implanted lenses for the eye.
- Its co-founders: CEO Rick Ifland and Chief Medical Officer Gary Wortz, MD, a board-certified ophthalmologist.
- See here for a look at Omega’s executive team—and click here for details on its Medical Advisory Board.
- And its lead technology: The Gemini Refractive Capsule.
Before we get into that, talk about this financing.
We don’t know exactly which investors were included in this latest round of financing, as the company only noted that it was led by a group of “strategically aligned ultra-high net worth investors.”
But we do know what the money will be used for, in Omega’s own words: “continued product development, intellectual property, regulatory activities, manufacturing scale-up, and clinical planning as the company prepares for future FDA studies and commercialization.”
Check out reports of its previous funding rounds, dating back as early as 2013.
Now to this proprietary technology.
In the simplest of terms: The company created a capsule that can replace the eye's own lens—representing a potential “new lens implantation approach.”
The Gemini Refractive Capsule is designed to provide a stable, biologically integrated platform for IOL implantation—all while preserving the capsular bag.
Give me more details.
There’s little information available on Omega’s website regarding the prototype design (and function, for that matter).
However, prior reports—including from CMO Dr. Wortz—have noted the 3D silicone implant’s symmetrical, thin design and insertion through a 2.2 mm incision via “the smallest available” IOL injector.
As for its function, Dr. Wortz stated that “much as the inner tube of a tire keeps it from deflating, [the capsule] prevents the capsular bag from collapsing,” by maintaining an open space.
And what does this open space allow for?
The potential incorporation of "multiple IOLs and additional drugs or devices, as needed.”
- This extends to biometric sensors, AR / virtual reality (VR) tech, and refractive lens platforms.
Worth noting: Its design also enables a proprietary, exchangeable optic—supporting improved long-term refractive stability.
And in plainer terms?
Essentially, the Gemini has been described as an injectable implant that holds the capsular bag open following cataract surgery and securely positions the IOL within the eye.
Can we get a visual of the whole process?
You can, actually! Check out this coverage of the implant from a few years ago (scroll down to watch the video).
So! Has the Gemini undergone any clinical evaluations yet?
It has … but not within the United States. Reports as recently as 2024 noted the implant was implanted in 50 humans and resulted in no “fibrosis or capsular opacity.”
And prior to that, this 2018 article written by William F. Wiley, MD, a consultant for Omega, described clinical results from the “first human experience” with the implant, which were presented during the 2018 ASCRS annual meeting.
That evaluation: The Gemini was implanted in the eyes of eight patients during cataract / IOL surgery; patients then underwent three postoperative exams over a 6-month period.
- And the results: Clinicians concluded:
- The implant maintained a large volume of space in the anterior capsule.
- The eyes implanted with the capsule had excellent visual acuities.
Sounds promising. And it’s still not approved?
It is not. However, we have news on that front:
In addition to this latest financing, Omega also announced an “FDA pre-submission meeting” is expected to take place, in which the company plans to “align its proposed regulatory pathway and clinical development plans with feedback from the FDA review team.”
“Omega intends to remain in close communication with the agency as the company advances toward initiating U.S. clinical studies,” it stated.
Any idea when this meeting will be?
Not a clue. But, rest assured; we’ll be on the lookout for any updates on this situation (including a timeframe for those potential U.S. studies) in the near future.