AnnMarie Hipsley, DPT, PhD, is the founder and CEO of Ace Vision Group (AVG), an emerging ophthalmic laser device company headquartered in Boston. AVG is currently focused on developing and commercializing its first product, the VisioLite Ophthalmic Laser System. The initial use for this device is Laser Scleral Microporation (LSM) for the treatment of presbyopia. Dr. Hipsley is a vision scientist, inventor, entrepreneur, author and speaker on ocular biomechanics and the biomechanical rejuvenation of the aging eye.

Ophthalmology Management: How does the Gen II VisioLite Ophthalmic Laser System work?

AnnMarie Hipsley, DPT, PhD: VisioLite is a first-in-class 2.94-um Er:Yag laser that contains a patented robotic motion controller, eye tracker and real-time Anterior Swept Source OCT, which allows the device to reach 360° of the extreme areas around the eye. The initial use for this device is LSM, a clinical-stage, ultra-minimally invasive rejuvenation therapy for treating presbyopia and potentially other eye diseases. The in-line OCT can perform real-time adaptive depth control. The VisioLite is designed with a software module to make the Microporation patterns precise, customizable and repeatable.

The ideal candidate for the LSM procedure is the emmetropic presbyope. Individuals with laser vision correction to emmetropia are also candidates. Since LSM does not touch the visual axis, it can be combined with other procedures. It is performed in the office and takes less than 10 minutes. Also, the cornea is untouched, so there is no photophobia or other refractive symptoms, which means the patient can start using the whole neuromuscular and biomechanical system right after the therapy — they can read, go back to work or go shopping. I have high hopes that this will be a world-changing technology in presbyopia and, hopefully, for some further indications of Microporation.

The Gen II VisioLite is undergoing final verification and validation in preparation for the FDA 510k submission and the first human studies in the United Kingdom. These steps will chart our course for US and EU clinical studies slated for late 2024.

OM: How does LSM work?

AMH: LSM is a minimally invasive laser therapy to rejuvenate the age-related ocular rigidity caused by advanced glycation end products, or AGEs. LSM works by uncrosslinking collagen bonds within the scleral microfibrils, which unwinds the collagen triple helix and decreases ocular stiffness to restore the “dynamic range of focus” (DRoF). LSM allows the natural dynamic movements of the ciliary muscles that shape the crystalline lens in the eye to move again. LSM can be utilized throughout the lifecycle of a pre-cataract presbyope at any stage or age without impact on the visual axis. It provides a dosable, re-treatable solution for the ever-progressive problem of crosslinking and age-related vision loss. LSM treats the problem, not the symptoms, and allows the eye to “see naturally” just the way the eye works by its intelligent design.

OM: What further benefits does AVG’s technology bring to the ophthalmic industry?

AMH: As a doctor of physical therapy with expertise in biomechanics and rehabilitation medicine, I saw an opportunity to restore a function in the eye instead of a surgical correction. AVG’s technology allows our doctors to have a therapeutic treatment in their hands that is ultra minimally invasive, doesn’t touch either optic (cornea or lens), and doesn’t preclude any future refractive surgery, cataract surgery, or any other glaucoma surgeries in the eye. Since it is a connective tissue treatment on the eye’s white part (sclera), it works by restoring physiological functions inside the eye and recovering age-related vision loss.

OM: What’s next for the company?

AMH: AVG is developing a 3D digital Artificial Intelligence (AI) predictive diagnostics platform called Virtual Eye Simulation Analyzer (VESA). We are building proprietary algorithms to train VESA using AI and machine learning to mimic a patient’s progression throughout the presbyopic lifecycle from a 30- to a 65-year-old eye. The future utility of VESA is to establish a “digital twin” of a patient’s eye in a virtual ecosystem, allowing clinicians to predict age-related changes to customize treatment interventions, outcomes and potential future pathologies. Another digital technology AVG is developing is Virtual Integrated Remote Assistance (VIRA), which would allow patients to interface with a remote digital assistant. VIRA gauges the rate of visual aging and the impact of health-related quality of life on the patient’s lived experience with presbyopia. Finally, an area AVG is exploring is an understanding if LSM can supplement monofocal or accommodating IOLs to reduce compromising other visual ranges. OM