Virtual Incision Has Achieved a Significant Milestone in its De Novo Request and is Closer to Potential Commercial Readiness

Virtual Incision Has Achieved a Significant Milestone in Its De Novo Request and is Closer to Potential Commercial Readiness 

Lincoln, Neb. – May 18, 2023 – Virtual Incision Corporation today announced its De Novo request was submitted and is under substantive review by the U.S. Food and Drug Administration (FDA). The submission seeks authorization to market ​the ​MIRA Surgical System for use in bowel resection procedures and comes on the heels of Virtual Incision’s completed Investigational Device Exemption (IDE) clinical study.

If granted, MIRA will become the first robotic-assisted surgery (RAS) device to obtain marketing authorization through the De Novo pathway for use in bowel resection procedures, making it a trailblazer in soft tissue robotics. Beyond granting Virtual Incision the ability to commercialize MIRA in the U.S. for its intended use, authorization may lay the foundations for expanded procedural indications, entry into international markets, additional instruments and accessories, and future generations of the surgical system.

“Throughout the history of RAS, only a few companies have managed to reach this significant milestone,” said John Murphy, president, and chief executive officer of Virtual Incision. “If we are successful with our submission, the FDA De Novo pathway will establish MIRA in a brand-new medical device category of miniaturized RAS. Our design is disruptive and highly differentiated among the current landscape of available and emerging technologies. We are proud of the data we collected, as it demonstrates the capabilities of MIRA in one of the most complex multi-quadrant abdominal procedures. We also observed many operational efficiencies that make the miniaturized approach so unique and potentially scalable to the millions of patients who could be candidates for RAS each year.”

If Virtual Incision obtains marketing authorization, the company plans to initiate a limited launch of MIRA in select centers across the U.S. These centers will aim to leverage the efficiencies created with MIRA to expand the number of patients they can treat with RAS. Their experiences will serve as best practices for the broader launch. In the longer term, the objective is to enable wide adoption in any healthcare facility for any patient undergoing abdominal surgery.

Click here to learn more and see the impressive team the company has assembled. A PDF of the press release is available here.

Shared by Tyler Stowater, board member of Virtual Incision Corporation.

One Millionth Patient Measured

As of today, one million patients have been measured on the Neurolens Measurement Device!

DALLAS, April 20, 2023 – Neurolens, a company commercializing innovative solutions to optimize vision, announced today that one million patients have been measured on the Neurolens Measurement Device, its cutting-edge eye tracking system that can identify eye misalignment as small as 0.01 Prism Diopters. Given the sharp acceleration in remote working and learning, optometrists have reported record numbers of patients experiencing the symptoms of eye misalignment such as headaches, eye strain and neck pain. Neurolenses have been proven to alleviate these symptoms for over 93% of patients.

“While we have grown tenfold in the past three years, the unmet patient need remains massive,” said Pierre Bertrand, Neurolens CEO. “Today we celebrate our one-millionth patient measured, a huge milestone for the organization. But with 80% of consumers experiencing symptoms of eyestrain according to The Vision Council’s recent report FocusedinSights: Digital Habits 2022, we are excited to continue bringing solutions to independent optometry to meet their needs. We are, first and foremost, in the business of patient outcomes.”

You can read the remainder of the article on Nueurolen’s newsroom or view this PDF copy of the story.

Shared by Steve Kirby, board member of Neurolens.

The Innovation Continues for Robotic-Assisted Surgery – Virtual Incision Completes FDA Investigational Device Exemption (IDE) Clinical Study for MIRA

Study results will be used to support the first FDA De Novo request for market authorization of the MIRA Surgical System as Virtual Incision makes progress towards its mission to expand RAS access

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Lincoln, Neb. – February 22, 2023 – Virtual Incision Corporation, a medical device company spearheading the development of the world’s first miniaturized robotic-assisted surgery (RAS) system, today announced the completion of its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study. The study was designed to evaluate the company’s MIRA Surgical System for use in bowel resection procedures. This is an important achievement towards bringing new technologies to hospitals and their surgical robotics programs regardless of the site of care.

The surgical cases were completed at three hospitals across the country. Patients who participated in the study were followed after their procedure to fulfill study requirements. The complete data will be correlated and submitted to the FDA as part of the company’s De Novo request for market authorization. Virtual Incision is the first RAS developer to complete a U.S. IDE study to support a De Novo request in bowel resection.

“The investigators are very encouraged by our experiences trialing the MIRA Surgical System,” said Michael A. Jobst, MD, colorectal surgeon. “Across the sites, we’ve seen MIRA efficiently integrate into existing RAS programs and witnessed how it is mobile enough for use in any operating room. Some sites have even completed multiple cases in a single day. We are eager to fulfill the clinical requirements of the study in hopes that MIRA can help expand RAS access to more patients in the future.”

There are 5 million Americans who undergo abdominal soft tissue procedures annually, however, more than 90 percent go without access to RAS. If authorized by the FDA, MIRA’s miniaturized, strong, and easy-to-use design could potentially increase the overall availability of RAS. It has the potential to integrate into any facility or operating room by serving as a complement to the existing mainframe RAS systems, or by expanding into new sites of care and geographies as a standalone. Virtual Incision aims to increase patient access through a clinically, operationally, and economically sound platform available to all providers.

“Completing MIRA’s IDE clinical study is a critical milestone in our journey to making RAS more accessible,” said John Murphy, president and chief executive officer of Virtual Incision. “Currently, less than 10 percent of the 90,000 operating rooms in the U.S. are equipped with mainframe RAS systems. Beyond the incredible progress of the industry pioneer, it’s still in the early days of the adoption of soft tissue surgical robotics. Our ultimate goal is to develop world-class miniature RAS devices with the required strength and dexterity to enable positive clinical outcomes for a broad range of procedure types.”

About the MIRA Surgical System MIRA is the world’s first miniaturized robotic-assisted surgery (RAS) system. Its small, sleek design is planned to offer the benefits of RAS during bowel resection procedures without the logistical inefficiencies of traditional mainframe robotics. The easily accessible device weighs approximately two pounds and offers internal triangulation with shoulders, arms, and infinite wrist roll inside of the body. It can be used in any operating room – a dedicated mainframe room is unnecessary. With its drape- and dock-free design and portability, MIRA is quick to set up, clean up, and move between cases. Its conveniently accessible design positions it to be used as a standalone system or a complementary tool for facilities that already own a mainframe. With MIRA, every operating room is RAS-ready.

About Virtual Incision

Virtual Incision is on a mission to simplify robotic-assisted surgery (RAS), so more patients and their surgeons can access its benefits every day. Headquartered in Lincoln, Nebraska, and holding over 200 patents and patent applications, the company is developing MIRA, the first-of-its-kind miniature RAS platform. Virtual Incision’s goal is to make every operating room RAS-ready. For more information, visit our website or follow us on LinkedIn and Twitter.

Cautionary Note Regarding Forward-Looking Statements

This communication contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations, assumptions, and other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date on which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions.

Shared by Tyler Stowater, board member of Virtual Incision Corporation.

ORASIS PHARMACEUTICALS SUBMITS NEW DRUG APPLICATION FOR INVESTIGATIONAL NOVEL EYE DROP CANDIDATE, CSF-1, FOR THE TREATMENT OF PRESBYOPIA

- Presbyopia is the loss of ability to focus on near objects as a result of the natural aging process and affects more than 120 million people in the U.S.

- Phase 3 NEAR-1 and NEAR-2 clinical trials, involving over 600 patients, met primary and key secondary endpoints and serve as the basis for the submission

PONTE VEDRA, Fla., Jan. 3, 2023 - Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop to improve near vision for people with presbyopia, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%).

"This NDA submission is a significant milestone for Orasis as we advance CSF-1 towards commercialization and achieving our goal of reshaping vision possibilities for patients," said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. "With more than 120 million people in the U.S. affected, we look forward to working with the FDA during its review process to ultimately provide an alternative treatment option for patients seeking flexibility in managing their presbyopia."

The NDA is based on data from the Phase 3 NEAR-1 and NEAR-2 clinical trials, involving more than 600 patients, which evaluated the efficacy and safety of CSF-1. Both trials met their primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity (DCNVA), and no loss of 1-line or more in distance visual acuity. The most common treatment-related adverse events of headache and instillation site pain occurred in only 6.8% and 5.8% of participants, respectively. Of all CSF-1 participants, only 2.6% reported moderate treatment-related adverse events. All other adverse events were mild.

Read the rest of the press release here on Orasis’ website or from a PDF here.

Shared by Tyler Stowater, board member of Orasis Pharmaceuticals.

Bluestem Lending A Hand

It is an annual tradition at Bluestem to lend a hand to support Sioux Falls Cares. Here is a picture of the members of the Bluestem gang who were able to help package boxes for Christmas deliveries in 2022. Merry Christmas everyone!

Zerigo Health Announces Release of Eczema Solution

•Zerigo Health’s latest software release includes integrated, guideline-recommended phototherapy dosing protocols for the treatment of atopic dermatitis (commonly referred to as eczema), in addition to its existing protocols for psoriasis

•Evernorth, Cigna’s health services business, will offer Zerigo’s solution as part of a pilot program through its Digital Health Formulary and is the first to launch this new platform for both psoriasis and eczema

San Diego, CA – Zerigo Health, which delivers the only connected light therapy solution for treating chronic skin conditions at home or on the go, today announced the launch of a new software release which includes integration of the American Academy of Dermatology Guideline protocols for the treatment of eczema with narrowband ultraviolet B (NB-UVB) phototherapy.

Evernorth, Cigna Corporation's health services business, is the first to launch Zerigo's solution for both psoriasis and eczema, which will be offered as a pilot program through its Digital Health Formulary. The Evernorth Digital Health Formulary connects employers, insurers and patients with innovative, affordable, and evidence-based care that meets their broader health care needs. The pilot program will enable more people with chronic skin conditions to better manage their conditions.

Click here for the rest of the press release shared on Zerigo’s website or a PDF copy of the file here.

Shared by Drew Doshier, board observer of Zerigo Health. 

Neurolens Raises $67 Million from MVM Partners, Falcon Vision/KKR, Marshall Wace & Existing Investors

Investment will be used to develop new products and drive adoption.

DALLAS, Texas, September 12, 2022 – Neurolens, a company commercializing innovative solutions to optimize vision, today announced completion of a $67 million financing. The financing was led by MVM Partners, with additional participation from Falcon Vision/KKR, Marshall Wace, and existing investors including Bluestem Capital. Raymond James was the exclusive agent on this round of financing. 

 The investment will fuel continued product innovation and growth initiatives, further accelerating the adoption of Neurolens.  

“While we have grown tenfold in the past three years, the unmet patient need remains massive,” said Pierre Bertrand, Neurolens CEO. “Nearly 6 out of 10 Americans are reporting daily symptoms of Digital Vision Syndrome, and we are excited to continue bringing solutions to independent optometry to meet their needs. We are grateful to see both current and new investors embrace our mission to transform eyecare beyond visual acuity.” 

Dr. Eric Bednarski, Partner at MVM, commented “Neurolens offers a remarkable solution to address the widespread problems that patients experience due to DVS. We are pleased to partner with Neurolens to support its continued growth.” Dr. Akhilesh Pathipati, Partner at MVM, added “The team at Neurolens has shown tremendous leadership and dedication while innovating in a market poised for growth. We are thrilled to work with them to continue changing the lives of patients.” Drs. Bednarski and Pathipati joined the Neurolens Board of Directors as a part of this financing. 

The investment follows two recent announcements signaling the unprecedented acceleration of Neurolens within the vision industry. In late August, Inc. revealed that Neurolens had been recognized as the 28th fastest growing healthcare company on its annual Inc. 5000 list, a prestigious ranking of the fastest-growing private companies in America. Earlier in August, Neurolens released the results of a parallel arm study evaluating reading speed at baseline. The study revealed that after seven days of lens wear, the average improvement in reading speed with Neurolenses was almost 70% higher than the improvement seen with other premium lens designs. 

To learn more about Neurolens, please visit our website at https://www.neurolens.com. 

About Neurolens  

Neurolens commercializes breakthrough technology to improve vision care. With patented contoured prism technology, Neurolenses are the first and only prescription lenses that go beyond visual acuity to provide comfort for the majority of adults who experience the symptoms of Digital Vision Syndrome (DVS), a description commonly used to describe a number of eye-related symptoms such as headaches, eye strain, motion sickness and dry eye sensation. The Neurolens contoured prism design helps the eyes work together comfortably, bringing the eyes into alignment to relieve the painful symptoms associated with DVS. Technology from Neurolens is only available to independent eyecare providers.  

About MVM Partners 

MVM has invested in high growth healthcare businesses since 1997. The firm has a broad, global investment outlook spanning medical technology, pharmaceuticals, diagnostics, digital health, and other sectors of healthcare.  

About Falcon Vision 

Falcon Vision is an ophthalmology-focused platform supported by KKR. The platform invests in and manages a diversified portfolio of emerging assets across medical devices and biopharmaceuticals. Falcon Vision’s strategy is to address the need for capital, access to executive talent, and operational guidance to support advancement of innovative products for under-managed ophthalmic diseases and vision preservation. Falcon Vision collaborates with the team at Flying L Partners to identify and execute new opportunities. 

About Marshall Wace 

Founded in 1997, Marshall Wace is a global alternative investment manager.  Marshall Wace combines fundamental investing with systematic and quantitative strategies utilizing proprietary systems and processes.

About Digital Vision Syndrome

Nearly 2/3 of adults experience the painful symptoms of Digital Vision Syndrome, which including chronic headaches, neck pain, eye strain and dry eye sensation. Fortunately, relief is in sight with Neurolenses, which go beyond visual acuity to restore naturally comfortable vision.

Shared by Steve Kirby, board member of Neurolens.

Virtual Incision Heads to Space with NASA Grant

On August 3, 2022, Virtual Incision Corporation shared this press release titled, “Virtual Incision’s Miniaturized Robotic-Assisted Surgery Device Will Launch into Space in 2024”. The story has been picked up by an industry publication, FIERCE Biotech, and you can read their story here.

Shared by Steve Kirby, board member of Virtual Incision Corporation.

Virtual Incision Announces Approval to Complete Clinical Study Enrollment for its MIRA® Platform

FDA decision supported by an interim clinical study report on patient safety

Lincoln, Neb. – April 19, 2022 – Virtual Incision Corporation, a medical device company pioneering the world’s first miniaturized robotic-assisted surgery (RAS) platform, today announced the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplement to complete the final stage of its clinical study analyzing the MIRA® Platform in bowel resection procedures. The approval was supported by a favorable interim clinical study report on the safety profile of MIRA.

The IDE supplement approval puts Virtual Incision on track to obtain the clinical evidence needed to bring innovation to the soft tissue surgical robotics industry, a market that has been historically dominated by a single player. Results of the completed study will support MIRA’s upcoming FDA De Novo application for market authorization.

Click here to read the remainder of the press release as published on the Company’s website, or click here to view a PDF version.

Shared by Steve Kirby, board member of Virtual Incision Corporation.

Farritor Wins Inaugural NU Faculty Commercialization Honor

Nebraska’s Shane Farritor is the inaugural winner of the University of Nebraska system’s intellectual property award.

In this story published on April 15, 2022, by Nebraska Today, Shane Farritor’s accomplishments are recognized as a result of the work he has done at Virtual Incision Corporation. Click here to read the story from the original source or click here for a PDF version of the story.

Virtual Incision Corporation -Shared by Steve Kirby, board member of Virtual Incision Corporation.

LENTECHS Receives Product of the Year from Contact Lens Spectrum

CEO, Robin Sears, from LENTECHS reported that Contact Lens Spectrum, in its 2021 Annual Report, recognized LENTECHS’ Apioc as Product of the Year! He commented that the company is honored with this award from such a respected and prestigious source.

Here is an excerpt from the publication: For our product of the Year, we solicited input from our readership for a specific contact lens, care solution, design, device, or concept (e.g., patent) that warrants recognition based on its impact or potential impact on the contact lens market. While we received nominations for many inspiring products, this year we name Lentechs’ Apioc lens as our Product of the Year.

Although not yet commercially available, this contact lens for presbyopia features a novel design unlike any other presbyopia lens on the market that delivers optical correction at all distances in a new way. This level of innovation is a remarkable accomplishment, and we congratulate Lentechs for this achievement.

Shared by Tyler Stowater, board member of Lentechs LLC.

OcuDoc Announces Grady Lenski as New Chief Executive Officer

OcuDoc Mobile by OcuDoc aims to be the first and only standalone smartphone app that can provide accurate, fast, objective autorefraction and TelerefractionTM, all without the need for additional equipment

COLUMBUS, OH, Dec 2, 2021 – Columbus-based ophthalmic MedTech startup OcuDoc announced the appointment of Grady Lenski as its new Chief Executive Officer. The firm is developing a breakthrough, mobile, autorefractor, named OcuDoc Mobile and brings on Mr. Lenski to lead the team given his extensive experience in the optical industry and deep relationships across the specialty worldwide.

“Grady is a globally-minded optical industry executive with experience in the C-Suite, as a board member, and as consultant for several world-class organizations—he’s the perfect leader for the team as it finalizes development and commercial planning,” emphasized OcuDoc board member and optical industry trailblazer, E. Dean Butler. Prior to founding his own consultancy, Mr. Lenski served as Chief Marketing Officer (CMO) of the Americas for Hoya Vision Care, and prior to joining Hoya, he worked at private-equity owned Performance Optics/Vision Ease as CMO and Vice President of North American Sales. He enjoyed a long tenure with PPG, serving lastly as managing director of adjacencies for Transitions® Optical. During his tenure he started and led businesses in North America and Asia-Pacific along with leading global business and strategy development. “I’m thrilled to join the OcuDoc Team at this exciting stage of its development. This technology will be a game-changer and serve so many worldwide—eyecare professionals (ECPs), retailers, and most importantly their patients and customers,” stated Mr. Lenski. The OcuDoc Team targets delivery of its prototype device for specific market testing in the second quarter of next year.

OcuDoc Mobile aims to be the first and only standalone smartphone app that can provide accurate, fast, objective autorefraction and TelerefractionTM, all without the need for additional equipment. In the United States and other regulated markets, ECPs and retailers will be able to use OcuDoc Mobile as their everyday autorefractor and send the app for patient and caregiver utilization at home, with results delivered back to the ECP. In less-regulated markets worldwide, OcuDoc Mobile will help elevate the world’s emerging middle class by providing an objective, accessible, and low-cost solution for vision screening and diagnosis to the billions who lack access to effective care.

Shared by Tyler Stowater, board member of OcuDoc, Inc.

Virtual Incision In The News

Please enjoy this story from Medical Device And Diagnostic Industry titled, “Virtual Incision’s Small Robot to Carve Out Large Piece of the Market” by Omar Ford published December 1, 2021. A PDF archive copy of the story is available here.

We think you will enjoy the story which includes a quote from John Murphy, Virtual Incision’s President and CEO.

Shared by Tyler Stowater, board member of Virtual Incision Corporation.

Virtual Incision Announces $46 Million Financing to Advance First-of-its-Kind MIRA Surgical Platform

IDE clinical study of robotic-assisted MIRA Surgical Platform currently underway for laparoscopic colon surgery

Lincoln, Neb., and Pleasanton, Calif. – November 30, 2021 – Virtual Incision Corporation, a medical device company pioneering first-of-its-kind miniaturized robots for laparoscopic surgery, today announced it has raised $46 million in a Series C funding round. The round was led by Endeavour Vision and Baird Capital with participation from returning investor Bluestem Capital and others. The funds will be used to support regulatory and clinical programs leading to the commercialization of the company’s MIRA® (“miniaturized in vivo robotic assistant”) Surgical Platform. Click here to view the press release.

Neurolens Wins "2021 EyeVote Reader's Choice Award"

We’re pleased to share with you the announcement an announcement from Neurolens. The company has been awarded the EyeVote Reade'r’s Choice Award for Diagnostic Instruments Brand Introduced in 2021 (NMD2). See the Company’s post here on LinkedIn.

Shared by Steve Kirby, board member of Neurolens.

Lentechs Announces Preliminary Results in Milestone Clinical Trial Evaluating its Investigational Contact Lens for Patients with Presbyopia

- Patients with presbyopia and presbyopia with astigmatism reported clinically meaningful and statistically superior distance vision for its investigational contact lens APIOC™ (pronunciation: AP•EE•OCK) over their habitual multifocal contact lenses, while having similar intermediate and near visual acuity

- Patients habitually wearing prescription glasses for their presbyopia and presbyopia with astigmatism reported comparable vision at distance, intermediate, and near with APIOC

COLUMBUS, Ohio, Nov. 11, 2021 /PRNewswire/ -- Lentechs, a clinical-stage ophthalmic medical device company developing a new generation of soft, suspended contact lens, designed to transform the treatment paradigm for presbyopia, today announced key results in a milestone clinical trial evaluating its investigational contact lens for patients with presbyopia and presbyopia with astigmatism. Click here to read the rest of the press release.

Additionally, the company posted this to their LinkedIn channel which you can view here.

Shared by Tyler Stowater, board member of Lentechs LLC

Zerigo Health Raises $43M in Series B Funding

Zerigo Health Raises $43 Million in Series B Funding to Drive Adoption of the Industry’s Only Connected Light Therapy Solution to Treat Chronic Skin Conditions

• Funding Round Led by 7wireVentures, joined by General Catalyst, Dragoneer, Cigna Ventures, Leverage Health Solutions, and Leaps by Bayer

• Glen Tullman, 7wireVentures Managing Partner and Former Livongo CEO and Founder, Named Executive Chairman

Click here to read the full press release.
Additionally, we invite you to see this story that tells more about the funding round and how it all came together.

Shoulder Innovations Announces FDA 510(K) Clearance for InSet™ Reverse Shoulder Platform Technology

HOLLAND, Mich., August 23, 2021 — Shoulder Innovations Inc, a leading innovator in the development of shoulder replacement systems, announced today that they have received FDA clearance for their InSet™ Reverse Shoulder Arthroplasty System.

The InSet™ Reverse Shoulder system seamlessly integrates and rounds out a best in class product line for shoulder arthroplasty including:

• Class leading AI enabled 3D PreView Software Planning solution to help ensure a more precise implant selection and placement.

• Broad range of implant types representing 6 different products, seamlessly integrated into one instrument tray allowing efficient treatment of patients with the simplest to the most complex pathologies, optimized for ASC environments,

• Convertible humeral platform demonstrating best in class fixation, the only true fully convertible humeral inlay system, and surprising minimally invasive bone preservation.

• Highly innovative instrumentation providing the simplest possible surgery.

• Published long term clinical data proving the effectiveness of the InSet system.

Click here to read the remainder of the press release or download a pdf copy here.

World’s First Surgery Using Virtual Incision’s MIRA Miniature Robotic System Performed at Bryan Medical Center in Lincoln, Nebraska

Company Begins IDE Study, Advancing Goal of Bringing Robotically Assisted Surgery to Any U.S. Hospital or Ambulatory Surgery Center

Lincoln, Neb., and Pleasanton, Calif. – August, 16, 2021 – Virtual Incision Corporation, a medical device company pioneering first-of-its-kind miniaturized robots for laparoscopic surgery, today announced that the world’s first surgery using the MIRA™ (“miniaturized in vivo robotic assistant”) Surgical Platform has been successfully performed by Michael A. Jobst, M.D., at Bryan Medical Center in Lincoln, Neb.

The robotically assisted right hemicolectomy procedure, which was completed using the MIRA surgical platform via a single incision within the navel, was performed as part of a clinical study of MIRA under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). The study will be conducted at a limited number of U.S. hospitals in support of the system’s regulatory pathway to approval.

Read the remainder of the press release here on VIC’s website or an archive PDF of the story here.

Santen and Sydnexis execute an exclusive licensing agreement for SYD-101, a novel investigational treatment for progressive childhood myopia

10 August 2021 – Geneva, Switzerland – Santen SA, a specialist in ophthalmology, and Sydnexis Inc., a biopharmaceutical company focused on the development of therapies for the treatment of progressive myopia, announce the signing of an exclusive licensing agreement for SYD-101, Sydnexis’ investigational proprietary low-dose atropine formulation, for Europe, Middle East and Africa (EMEA). SYD-101 is currently undergoing a large multicentre phase III clinical trial, the STAAR study, in Europe and the US.

“Uncorrected myopia is the leading cause of distance vision impairment and it is children with early onset who are at greater risk of long-term eye complications,” says Dr Martina Brandner, Department of Ophthalmology, Medical University of Graz, Austria. “At present, only the symptoms of myopia are corrected and so researching SYD-101 in the largest clinical study in this field is a critical step in finding a treatment to target the underlying disease.”

Click here to read the rest of the press release.