AcuFocus Submits IPO Prospectus for Its Pioneering FDA-Approved Small-Aperture Intraocular Lens, IC-8® Apthera™

"Vision Problems in the U.S." points out that in the United States, there were 24.4 million cases of cataracts in 2010, and it is projected that this number will double by 2050, reaching approximately 50 million cases.

Most cases of cataracts are age-related. Some people begin to experience blurred vision in their 40s, and many will develop cloudy lenses in their 50s or 60s. "By the time you're 80, almost everyone will have some form of cataract," said Dr. Manuel B. Datiles III, a medical officer and senior clinical investigator at the National Eye Institute (NEI), under the U.S. National Institutes of Health (NIH). This cloudiness can become so severe that it may even lead to blindness. The report *Global estimates of visual impairment: 2010* once pointed out that more than half of the world's blindness cases are caused by cataracts. Moreover, cataracts are the leading cause of blindness among adults aged 50 and above globally.

Cataracts refer to a condition where various causes lead to metabolic disorders of the lens, causing denaturation of lens proteins and resulting in opacity. If not treated promptly, it may lead to symptoms such as decreased vision, refractive changes, double vision, or even blindness. When vision loss caused by cataracts begins to affect daily life, doctors typically recommend cataract surgery, which involves removing the natural lens obscured by the cataract and replacing it with an intraocular lens (IOL).

AcuFocus, Inc. is a private ophthalmic medical device company dedicated to this field. Its core product, the IC-8® Apthera™ intraocular lens (hereinafter referred to as Apthera IOL), provides a groundbreaking small-aperture intraocular product to address various unmet needs in eye care and help patients achieve optimal personal vision. The Apthera IOL (marketed globally as the IC-8 IOL) has been approved for use in the United States for the treatment of cataract patients.

Generally, cataracts can only be treated by surgically removing the cloudy natural lens and implanting an intraocular lens (IOL). Most patients receive a monofocal IOL during cataract surgery. While monofocal IOLs provide excellent distance vision, objects viewed up close may still appear blurry. Even with some advanced IOL designs that offer near, intermediate, and distance vision, clear imaging is only provided at specific focal points (usually two or three). For patients, objects between these specific focal points may still appear blurry.

Replacing the natural lens with the Apthera IOL can provide a continuous and clear range of vision from near to far, including intermediate distances. The Apthera IOL is the first small-aperture IOL specifically designed for cataract patients and is suitable for monocular implantation after cataract surgery removal of the natural lens in cases where preoperative corneal astigmatism reaches up to 1.5 diopters (D). Typically, a monofocal IOL is implanted in the patient's other eye.

Apthera IOL focuses light through a small aperture, enabling patients to see nearby and intermediate objects clearly while maintaining their distance vision. First, a monofocal or toric monofocal intraocular lens is implanted in the patient's dominant eye to provide good distance vision (emmetropia). Then, the Apthera IOL is implanted in the non-dominant eye. This allows the patient to achieve monovision, where the dominant eye handles distance vision and the non-dominant eye manages near and intermediate vision. When the Apthera IOL works in conjunction with a monofocal or toric monofocal intraocular lens, it provides a reliable and continuous range of vision from near (such as reading) to intermediate (such as computer work) to far (such as viewing road signs), without any blurred zones. Additionally, the Apthera IOL offers extended depth-of-focus capabilities, allowing patients to achieve better near and intermediate vision without sacrificing distance vision quality or contrast sensitivity.

Presbyopia is a progressive vision condition that typically begins to appear after the age of 40. Over time, the eye's natural lens becomes too rigid to focus light, making it difficult for patients to see nearby objects clearly. Generally, corrective lenses designed for presbyopia feature complex optical structures that provide clear vision at multiple discrete focal points by splitting, shifting, or stretching light.

As the first IOL design to mitigate the effects of presbyopia using its embedded FilterRingTM component, AcuFocus' Apthera IOL does not split, move, or stretch light. The Apthera IOL is a wavefront-filtering intraocular lens suitable for 82% of cataract patients. The Apthera IOL utilizes a patented FilterRing™ component built into the lens to help improve patients' vision. This FilterRingTM component creates a small aperture that allows focused light to enter the eye while filtering out unfocused light that causes blurriness. It delivers centrally focused light to the retina by filtering out peripheral defocused and distorted light that reduces image quality.

This innovative mechanism of action provides patients with a continuous and clear range of vision from far to intermediate and near. With the Apthera IOL, light naturally focuses as it enters the eye, seamlessly expanding the patient’s field of view, allowing them to see objects, people, and even text across the entire focal range. Additionally, the Apthera IOL performs seamlessly in both bright and low-light conditions, delivering high-definition vision with smooth transitions within the visual field.

At the same time, the Apthera IOL is also the first extended depth of focus (EDOF) intraocular lens designed for monovision. EDOF intraocular lenses represent the latest type of IOLs for treating presbyopia, capable of extending the focal point to provide seamless continuous vision from far to intermediate distances while expanding the patient’s field of view and reducing the occurrence of halos and glare. It can decrease the need for patients to wear glasses after cataract removal while simultaneously addressing presbyopia, with some IOL designs also offering functional near vision. Dr. Elizabeth Yeu of Virginia Eye Consultants in Norfolk, Virginia, stated: “The Apthera IOL is unlike any previous intraocular lens; it will fill a significant gap in our IOL device offerings, providing new treatment options for every cataract patient.”

As early as 2015, the Apthera IOL obtained the CE mark and has been marketed in Australia, New Zealand, Singapore, and parts of Europe.

In July 2022, AcuFocus announced that the Apthera IOL received FDA approval, marking it as the first and only small-aperture intraocular lens for cataract surgery. The Apthera IOL has garnered numerous "firsts" in its category, including being the first small-aperture intraocular lens to receive FDA approval, the first intraocular lens suitable for co-implantation in the same eye with a monofocal or toric monofocal intraocular lens, the first extended depth-of-focus intraocular lens designed for monovision, and the first non-toric intraocular lens suitable for cataract patients with low corneal astigmatism.

The FDA approval of Apthera IOL was based on data from the U.S. Investigational Device Exemption (IDE) trial, which evaluated the safety and effectiveness of implanting Apthera IOL in one eye and a monofocal or toric monofocal intraocular lens in the other eye. The control group participants had monofocal or toric monofocal intraocular lenses implanted in both eyes. A total of 453 participants were involved in the trial and followed up for 12 months. The results showed that Apthera IOL participants were comparable to the control group participants in uncorrected distance vision, and significantly outperformed the control group participants in intermediate and near vision. Under bright and dim light conditions, the binocular contrast sensitivity of Apthera IOL participants was also comparable to that of the control group participants.

In its financing journey, Apthera IOL was invested twice by Medtronic's China Healthcare Fund. In 2016 alone, Apthera IOL completed five rounds of financing. According to the Crunchbase website, after dozens of financing rounds, Apthera IOL’s total funding has reached $212.6 million.

 Data source: VCBeat

On January 17, 2023, Bausch + Lomb Corporation (NYSE/TSX: BLCO) announced that its subsidiary has acquired AcuFocus pursuant to a merger transaction with AcuFocus’ parent company. Bausch + Lomb is a well-established name in eye care with a fully integrated portfolio of ocular health products. "With Bausch + Lomb's extensive development footprint and renowned commercial expertise, we believe Bausch + Lomb is best positioned to introduce, recommend Apthera IOL to physicians, and ultimately ensure more cataract patients benefit from this novel IOL," said Al Waterhouse, president and chief executive officer of AcuFocus.