Bausch + Lomb Acquires Elios Vision to Expand Minimally Invasive Glaucoma Surgery Portfolio

Dec 16, 2024 10:28 CST Updated 10:28

Elios Vision

Glaucoma Treatment Solution Developer

Source: Elios Vision ；Editor: Sophia

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Minimally Invasive Glaucoma Surgery (MIGS) has become a hotspot for intensive investment by major ophthalmology companies in the past two years. Giants such as Alcon, Bausch + Lomb, AbbVie, and Allergan have invested over 5 billion yuan in total in the MIGS field.

Recently,Bausch + LombAnnouncementAcquired through its subsidiaryElios Vision`, the latter being the developer of the Elios procedure.`ELIOS surgery is a procedure that uses equipment produced by Elios Vision.Non-Implantable Excimer LaserMinimally Invasive Glaucoma Surgery (MIGS)。

Unlike traditional MIGS, ELIOS is an implant-free surgery,Using high-precision, non-thermal excimer laser to enhance the natural outflow pathway. The laser creates 10 microchannels (diameter 210 µm) through the trabecular meshwork, forming tiny openings within the trabecular meshwork to facilitate aqueous humor outflow while preserving the trabecular meshwork.This surgery can be performed simultaneously with cataract surgery or separately.。

ELIOS SurgeryHas obtained CE certification in Europe and is currently undergoing clinical trials in the United States.Elios Vision has completed trial registration for more than 300 patients with mild to moderate glaucoma, who will undergo ELIOS surgery without implants in conjunction with cataract surgery.

The financial terms of this acquisition were not disclosed., but it provides a new opportunity for effectively treating glaucoma with implant-free cataract surgery, enhancing Bausch + Lomb's ability to offer comprehensive glaucoma solutions.

According to Market Scope, the number of MIGS procedures is projected to double by 2027. Moreover, there is increasing evidence supporting combined phacoemulsification and MIGS. Technologies like ELIOS can help expand the treatment base for physicians offering MIGS and leverage the benefits of combined surgeries.

# ELIOS/Implant-Free Excimer Laser

Research and Development Background

In a healthy eye, aqueous humor can flow freely through the trabecular meshwork into the drainage canal, maintaining normal intraocular pressure. However, in eyes with glaucoma, this drainage system may malfunction, leading to blockage of the drainage canal. Specifically,The normal flow of aqueous humor is obstructed, causing fluid to accumulate inside the eye.。

Left: Healthy eye Right: Eye with glaucoma

The accumulation of this fluid leads to increased intraocular pressure (IOP).Long-term high intraocular pressure can damage the optic nerve, potentially leading to vision loss. The damage to the optic nerve is usually irreversible, making it crucial for glaucoma patients to control intraocular pressure in a timely manner.

Currently, limiting the impact of glaucoma progression on visionThe only way is to reduce intraocular pressure., usually throughIOP-lowering drugs, micro-stent implantation, traditional filtration surgeryAnd other methods to improve.

ELIOS Surgery

As aMinimally Invasive Glaucoma Surgery (MIGS) Using Excimer Laser, which uses excimer laser to create microscopic openings in the trabecular meshwork to restore the natural flow of aqueous humor, thereby reducing intraocular pressure.

This surgery isWithout implants, which means it does not involve placing any permanent devices inside the eye and can be performed simultaneously with cataract surgery.

Technical Advantages

Trauma and Recovery Time:ELIOS Surgery is a minimally invasive surgery with minimal trauma and quick recovery. There is no movement during the surgical procedure. When the laser is emitted, the probe remains fixed and aimed at the trabecular meshwork. With other devices, movement may sometimes be required, potentially harming a larger area of the ciliary body, causing more bleeding or tears.
No Implants:ELIOS surgery does not require the implantation of any permanent devices, whereas microstents do require implants.
Reduced Postoperative Drug Dependence:ELIOS surgery can reduce postoperative reliance on intraocular pressure-lowering medications, whereas medication treatment and traditional surgery may require long-term or lifelong medication use.
Long-term effects:ELIOS surgery demonstrates lasting intraocular pressure control, while medication and traditional surgery may require treatment adjustments over time.

ELIOS, as a minimally invasive, implant-free glaucoma surgery, offers a new treatment option compared to traditional intraocular pressure-lowering medications and filtration surgeries, particularly in...Reduce postoperative drug dependence and microtraumahas advantages in aspects.

Clinical Trial Performance

ELIOS has been tested in more than 200 patients.This treatment can stably reduce intraocular pressure (by an average of about 15 mmHg) and alleviate the economic burden of IOP-lowering medications.Three objective outcomes were observed in patients treated with ELIOS: reduction in intraocular pressure, decrease in medication usage, and improvement in quality of life.

A large number of prospective studies and follow-ups lasting up to 8 years have shown that,ELIOS can significantly reduce intraocular pressure (by 29-43%) and decrease the usage of clinically significant IOP-lowering medications, with a low incidence of severe adverse side effects.In a retrospective study of cataract surgery combined with ELIOS in patients with primary or secondary open-angle glaucoma, the average intraocular pressure decreased by more than 20% after 8 years. Over a period of up to 4 years, there was a significant reduction in medication use (see figure below), and only 3.7% of patients required a second filtering surgery.

In these more than 200 ELIOS surgeries, the majority were combined with phacoemulsification. A retrospective review and at least 4 years of follow-up for the first 69 eyes with mild (n=50), moderate (n=10), or severe (n=9) primary open-angle glaucoma showed,An average 35% reduction in intraocular pressure. More importantly,75% of patients discontinued drug treatment within 4 years.In the years following treatment, only four eyes required trabeculectomy surgery.Compared with preoperative medication for lowering intraocular pressure, the intraocular pressure was reduced by 20% at 4 years, while medication treatment only reduced it by 1.35%.。

ELIOS may be an effective method for controlling early glaucoma and can be integrated into routine cataract surgery.

# Boost Key Business

Glaucoma Treatment

In fact, this is not the first time Bausch + Lomb has invested in minimally invasive glaucoma surgery. As early as 2022, Bausch + Lomb invested in an Israeli company.MIGS Company SanoculisThe two companies also reached a strategic cooperation, and Bausch + Lomb obtained the exclusive distribution rights of Sanoculis in Europe.

Announcement Details:

In July 2022, Sanoculis, an Israeli ophthalmic medical device startup, announced that it had signed a strategic agreement with Bausch + Lomb aimed at addressing unmet treatment needs for glaucoma. The two companies have reached an agreement on the development by Sanoculis ofAn innovative minimally invasive surgical instrument for the treatment of glaucoma (“MIMS®”)Signed an exclusive distribution agreement in Europe. In addition, Bausch + Lomb made an equity investment in Sanoculis as part of the latter's Series C financing. According to the terms of the agreement, Bausch + Lomb also obtained an acquisition option for Sanoculis.

MIMS Minimally Invasive Glaucoma Surgery System

Sanoculis was founded in 2012 by Yoseph Glovinsky, a senior ophthalmology expert at Sheba Medical Center in Israel, based on his personal invention. Yoseph currently serves as the Chief Medical Officer of Sanoculis. The core product developed by Sanoculis, MIMS, is a simple and rapid treatment for glaucoma.Effectively reduce intraocular pressure without invasive surgery. MIMS completes the procedure by creating a scleral-corneal drainage channel during the operation., so there is no need to implant a stent in the eye as in existing stent surgery.

The full name of MIMS technology is "Minimally Invasive Sclerostomy." Its equipment includes a multifunctional machine and a kit containing all the necessary medications for the surgery. During the operation, the doctor can use this machine to lift the conjunctiva after，A very thin probe is inserted through the cornea and slowly rotated to create a tiny channel with a diameter between 50-100 micrometers.The excess aqueous humor drains out and forms a small blister within the conjunctival layer. The fluid in the blister can freely transfer inside and outside the eyeball, which is greatly helpful for later adjustment of intraocular pressure.

MIMS Minimally Invasive Glaucoma Surgery

MIMS technology obtained EU CE certification in March 2017., providing a safer and more effective solution for glaucoma patients who require long-term medication and traditional surgical trabeculectomy or glaucoma drainage valve implantation.

Dry Eye Treatment

In addition to boosting its glaucoma therapy, Bausch + Lomb also acquired another company this year to strengthen its focus on dry eye syndrome.

In August 2024, Bausch + Lomb announced that its subsidiary had been acquired from private equity owner AccelMed Partners and other shareholders.Acquired Trukera Medical.This acquisition will help to enhance its product portfolio in the dry eye treatment field.

Trukera Medical is an ophthalmic medical diagnostics company headquartered in the United States, developingScoutPro^®It is the world's only portable tear osmolarity testing device., used for precise measurement of tear osmolarity.

Hypertonicity (hyperosmolarity) is a condition that cannot be detected by slit-lamp examination and isMain Indicators and Core Etiology of Asymptomatic Dry Eye Disease (DED) and Ocular Surface Disease (OSD), if not effectively treated before surgery, may negatively impact the outcomes of corneal, cataract, and refractive surgeries.

ScoutPro UtilizesTemperature-Corrected Impedance MeasurementTo indirectly assess osmolarity. Osmolarity is calculated and displayed as a quantitative value by applying a calibration curve to the steady-state impedance of tears.

ScoutPro is currentlyThe World's Only Portable Tear Osmolarity Testing DeviceIt uses advanced microfluidic impedance spectroscopy for real-time measurement, completing the collection and analysis of nanoliter tear samples in a single device, integrating tear collection and osmolarity detection.Osmolality can be precisely measured in about 15 seconds.。

# Intensive Layout by Giants

Glaucoma is an irreversible blinding eye disease characterized by visual field defects and characteristic optic nerve damage. It is estimated thatBy 2040, there will be over 110 million glaucoma patients globally.The treatment of glaucoma mainly involves reducing intraocular pressure through medication, laser, or surgery to control disease progression.

There are various types of glaucoma surgeries. Traditional glaucoma surgeries, such as trabeculectomy, Ex-Press shunt implantation, and drainage valve implantation (e.g., Ahmed, Baerveldt), can effectively control intraocular pressure but are more prone to intraoperative and postoperative complications like hypotony, filtering bleb infection, and filtering bleb scarring. Therefore,Minimally Invasive Glaucoma Surgery (MIGS) Emerges。

The definition of MIGS by the American Glaucoma Society is a method to reduce intraocular pressure via an internal or external approach.This surgical technique involves a smaller or no scleral incision, with minimal or no conjunctival manipulation.According to the different principles of pressure reduction and action sites, a summary of various MIGS procedures reported in the current literature is shown in the table below.

MIGS can be divided into four categories according to the clinical treatment pathway. The first category isCiliary Body Destruction Surgery, destroying the ciliary body that produces aqueous humor, so that it produces less aqueous humor, is currently being promoted in China.UCP (Ultrasound Cyclo Plasty)Belongs to this category; the second category isSubconjunctival Drainage, draining the aqueous humor to the subconjunctival space, with representative products beingXEN; The third category isThrough the trabecular meshwork into Schlemm's canalThe approach, representative products are from the United States.iStent inject, Hydrus, and ELT; The fourth category isSuprachoroidal Drainage, representing the product asiStar Medical。

Ciliary body destruction surgery, taking UCP as an example,UCP TechnologyDeveloped by French company EYE TECH CARE, a non-invasive surgical technique used for treating glaucoma, has been approved by the China Food and Drug Administration (CFDA) for marketing in China. This technology is currently being promoted in multiple ophthalmic hospitals, including Aier Eye Hospital.

Allergan's XEN belongs to the subconjunctival drainage field. XEN was approved by the FDA for marketing in 2013, and in 2020,Allergan'sXEN Glaucoma Drainage TubeApproved in China, and has currently completed the first surgery at multiple hospitals across China.

XEN Implant Example

The trabecular meshwork—Schlemm's canal pathway is the route with the highest aqueous humor outflow, and the representative product of this pathway is the iStent series launched by Glaukos. Glaukos, founded in 1998, was the world’s first company to bring MIGS procedures to market. The iStent series includes three generations, with the first-generation product, iStent, launched in 2012.

In November 2024, Glaukos Corporation announced its productThe third-generation glaucoma drainage device, iStent inject W, has been approved by the National Medical Products Administration (NMPA) for marketing in China., for the treatment of intraocular pressure reduction in mild to moderate open-angle glaucoma combined with cataracts. Gaush Medical is the exclusive partner for this innovative product in mainland China and Macao.

iStent inject W

iStent inject W consists of a pusher and two pre-installed stents (implants), and its mechanism of action isBy implanting a stent into the trabecular meshwork, a new drainage channel is created., reduce the aqueous humor outflow resistance in the trabecular meshwork and the inner wall of Schlemm's canal, thereby reconstructing the physiological aqueous humor drainage pathway, and ultimately achieving the goal of reducing intraocular pressure. The surgery does not damage the trabecular meshwork tissue, maintains the integrity of the intraocular tissue structure, and minimizes tissue trauma and postoperative complications to the greatest extent.

The most representative product in the suprachoroidal space prior to this was Alcon's Cypass, launched after its acquisition in 2016. However, CyPass was recalled two years after its market release due to excessive loss of corneal endothelial cells. Nevertheless, this approach is still highly regarded by industry giants.Received a 300 million yuan investment from AbbVieMINIject developed by iStar MedicalWhich belongs to the suprachoroidal treatment pathway.

MINIject is a 5mm-long, oval-shaped (1.1mm*0.6mm cross-section) supraciliary implant produced by iStar Medical. Its material isA soft, biocompatible, non-degradable medical silicone materialIt contains numerous loose porous structures, with approximately 180,000 pores in each MINIject. Each pore has a diameter of about 27 μm, ensuring the smooth outflow of aqueous humor.

MINIject

But for companies in China,Due to the differences in disease types and medical environments between China and other countries,The R&D of MIGS products faces more challenges。In Western countries, open-angle glaucoma is the main type, accounting for 74% of glaucoma patients, whileIn China and Southeast Asia, the main type of glaucoma is angle-closure, accounting for 87% of glaucoma patients.

Moreover, due to the insidious onset of primary open-angle glaucoma, there may be no symptoms in the early stages.Patients in China are often diagnosed at the middle or late stage.However, most of the MIGS products developed by European and American companies can only be used for early or mild patients. ThereforeMIGS products from Chinese companies should focus not only on open-angle glaucoma but also on angle-closure glaucoma and patients in the middle to late stages.. The main companies布局 in this track areElios Vision, Hisigene, Mingche Bio。

Elios Vision Medical Team Collaborates with Professor Liang Yuanbo's Team to DevelopAqueFish® Glaucoma Schlemm's Canal Drainage Stent, and further proposed "Stent-assisted Internal Trabecular Drainage Surgery (SLITs)." AqueFish® Glaucoma Schlemm's Canal Drainage Stent is one of the few globally.Applicable to both open-angle glaucoma and closed-angle glaucoma.Glaucoma treatment solutions, the core technology of the product has been granted invention patents in China, the United Kingdom, and the United States.

According to the introduction, the AqueFish® stent-assisted internal trabecular drainage surgery can maximize the preservation of the integrity of Schlemm's canal and the trabecular meshwork, reduce damage to the endothelial cells and structure of Schlemm's canal, features minimal surgical trauma and short operation time, and can be applied to patients with open-angle or closed-angle glaucoma who require surgical reduction of intraocular pressure. Due to its physiological internal drainage nature, it is not dependent on filtering blebs, and its long-term success rate may be superior to traditional external trabeculectomy and similar procedures, with a lower incidence of complications. This productCompleted the world's first patient enrollment in August 2023。

Haisi Guide R&D and production for open-angle glaucomaMicroCOGO® Trabecular Micro-Stent Drainage SystemFor the time beingThe world's smallest Class III implant,Designed forReduce Intraocular Pressure in Patients with Mild to Moderate Open-Angle GlaucomaAccording to the company's person in charge, the diameter of the peripheral stent of the system is less than 300 microns. The stent also features very intricate drainage channels, special coatings, and other designs, with the smallest drainage pore size being approximately forty to fifty microns. November 2022,The product has entered the multi-center clinical trial in China and completed the first enrollment surgery.。

MicroCOGO® Trabecular Micro-Stent Drainage System

Elios Vision's self-developedMinimally Invasive Glaucoma Drainage TubeIn terms of product structure, it follows the same lineage as XEN, but unlike XEN's equal-diameter drainage tube, Mingche BioAdopting a gradient inner diameter design to effectively improve drainage efficiency, while achieving targeted drainage, anti-reflux, and preventing postoperative complications such as excessively low intraocular pressure. The outer wall of its product adopts a positioning structure to achieve intraoperative positioning, which increases the success rate of single implantation during surgery and prevents postoperative displacement complications.

Conductivity Performance Test of Stents

Glaucoma is the second leading cause of blindness globally, second only to cataracts, but it ranks first as an irreversible blinding eye disease. The biggest difference between glaucoma and cataracts is that while cataracts can be treated with surgery to restore vision, the vision loss caused by glaucoma is irreversible and cannot be remedied through medication or surgery.China Has the Largest Number of Glaucoma Patients GloballyAccording to the "Chinese Glaucoma Guidelines (2020)", it was estimated that by 2020, the number of glaucoma patients in China had reached 21 million, with up to 5.67 million people potentially blinded by the condition.

However,EyeThe development of MIGS technology in China is still in its early stages.To gain wider recognition of MIGS among doctors and patients, more data from Chinese companies is needed to address the issue.

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