Latest Industry News & Trends

Changes in NIH Grant Rules Threaten to Ripple Through Eye Disease Research

Any changes to the rules that accompany US government research grants could affect eye research in the US in a big way. The US government awards an average of $1.1 billion a year in grants to resea...

AGS Meeting Features Technology Updates, Voyager DSLT Launch

The 40th Annual American Glaucoma Society (AGS) meeting was highlighted by fast-paced sessions for providers, updates on the latest surgical technology, and the launch of Alcon’s Voyager DSLT. The ...

Ophthalmic Company Revenue Up 5.1 Percent as Four Firms Report Record-High Quarters

Ophthalmic manufacturer revenue in Q4-2024 totaled $12.0 billion. Revenue increased 5.1 percent from the same quarter in 2023 and decreased 0.3 percent from Q3-2024. The total includes Market Scope...

Ophthalmologists Report 5.3 Percent Increase in Q4-2024 Procedure Volume

US ophthalmologists reported that ophthalmic procedures increased 5.3 percent in Q4-2024 compared with the same quarter in 2023, according to Market Scope’s latest survey. Year-over-year performanc...

US FDA Approves Neurotech’s Cell Therapy Implant for MacTel

Neurotech Pharmaceuticals announced March 6 that the US FDA had approved Encelto, an encapsulated cell therapy implant to treat macular telangiectasia (MacTel) type 2. It’s the first FDA-approved t...

Topcon, RadiusXR, and Glaukos Team Up to Launch Inspire VR Perimeter Headset

Topcon Healthcare, RadiusXR, and Glaukos announced March 11 that they are teaming up to launch RadiusXR’s new wearable vision testing platform, Inspire. The companies said the partnership capitaliz...

Optos Unveils MonacoPro Ultra-Widefield Retinal Imager with SD-OCT

Optos, a division of Nikon, announced Feb. 14 the launch of the MonacoPro, its next-generation ultra-widefield scanning laser ophthalmoscope with integrated spectral domain optical coherence tomogr...

PDUFA Dates for Ophthalmic Drug Candidates

The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.

Select US FDA Approvals and Clearances in February 2025

There was one US FDA clearance through the ophthalmic device division using the 510(k) pathway in February 2025, according to the agency’s database. New World Medical gained clearance of its Via360...

Retina Surgeons Ready for Alcon to Make a Splash with Unity VCS

Alcon looks ready to shake up the retinal treatment device market with the launch of the Unity VCS later in 2025. Anytime the world’s number one manufacturer of vitreoretinal surgical systems intro...

US FDA Accepts NDA for Glaukos’ Epioxa for Epi-On Crosslinking Therapy

Glaukos, of Aliso Viejo, California, reported Feb. 24 that the US FDA had accepted its new drug application for Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy, for th...

Meet with Market Scope at the 2025 ASCRS Meeting

Market Scope will be located at Booth No. 1002 at the 2025 ASCRS meeting in April at the Los Angeles Convention Center. Contact us to set up a time to discuss your custom research needs. Reach us a...

Chinese Regulators Approve Zeiss’ VisuMax 800 with SMILE Pro Software

Germany’s Carl Zeiss Meditec announced Feb. 26 that the National Medical Products Administration in China had approved its updated VisuMax 800 femtosecond refractive laser and related SMILE Pro sof...

Clinical Trial Updates for Ophthalmic Candidates, March 2025

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

2025-2026 Ophthalmic Meetings Calendar

Market Scope regularly updates its list of ophthalmic meetings to keep the information current. Please contact us at matthewdouty@market-scope.com if we do not have your meeting listed. Thank you.

New Arkansas Law Reins in Vision Care Insurers’ Influence over ODs

Optometrists in Arkansas celebrated a legislative victory on Feb. 25 when Gov. Sarah Huckabee Sanders signed into law HB 1353, which supporters say will allow ODs in the state to receive more fair ...

ARVO Extends Deadline for Attendees to Meeting to Pay Reduced Fees

The Association for Research in Vision and Ophthalmology (ARVO) announced March 10 that it had extended the deadline for reduced registration fees for its annual meeting. The lower rates are now in...

Medicare Physician Fee Cut Won’t be Rolled Back in March

US House members on March 9 dropped language from a stopgap funding bill that would have rolled back the 2.83 percent cut in Medicare reimbursement for doctors that went into effect Jan. 1. The mov...

Deerfield Sues Alcon over Latest Moves to Prevent Aurion IPO

Deerfield Management has filed a lawsuit against an Alcon subsidiary, seeking to prevent Alcon from interfering with Aurion Biotech’s ability to launch an initial public offering. The lawsuit, file...

Study of Corneal Stem Cell Transplant Shows Vision Restored After Injury

A clinical study of patients with irreversible corneal injury, published March 4 in Nature Communications, showed that transplanted epithelial stem cells from their healthy eyes restored at least p...

Early Study Shows Promise for Head-Mounted Retinal Surgery Robot

Researchers at the University of Utah’s John A. Moran Eye Center and John and Marcia Price College of Engineering reported Feb. 19 that they have collaborated to create a new robotic surgery device...

New World Medical Gains US Clearance for the Via360 Viscodilation System for Glaucoma

New World Medical announced Feb. 18 that it had received 510(k) clearance from the US FDA for its Via360 glaucoma surgical system. The Rancho Cucamonga, California, company said the device would be...

Emerging Companies Pursuing Ophthalmic Indications, March 2025

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

Weekly Corporate and Surgeon Poll, March 2025

BVI Leads Latest Ophthalmic Fundraising with $1 Billion in Strategic Capital

BVI Medical led recent ophthalmic fundraising efforts with $1 billion in strategic capital, raised from owner TPG and new investors, to continue expanding globally. Financing announced in the past ...

March 2025 Ophthalmic News Briefs

Alcon announced the US launch Feb. 24 of its Systane Pro Preservative-Free (PF) over-the-counter eye drops for dry eye. The company said Systane Pro PF is the longest lasting eye drop in the Systan...

G360’s New Horizons Forum Highlights Innovations and Discusses the Future of Glaucoma Therapy

The Glaucoma 360 New Horizons Forum provided an update on technologies with high interest, as well as devices just gaining attention. The forum was held Feb. 7 in San Francisco, California, and dre...

Bausch + Lomb Rules Out Sale After Concluding Bid Process

Bausch + Lomb announced Feb. 6 that it had ruled out a sale of the company, after exploring the option in its bid for a full separation from parent company Bausch Health. “Taking Bausch + Lomb priv...

Norlase Strengthens Position in Ophthalmic Laser Market with Launch of Lynx LIO

Norlase strengthened its position in the ophthalmic laser market on Jan. 22 when it launched Lynx, the world’s first pattern scanning laser indirect ophthalmoscope (LIO). The Lynx laser and pattern...

Australian Regulators Approve Apellis’ Syfovre for Patients with Geographic Atrophy

Apellis Pharmaceuticals announced Jan. 27 that Australia’s Therapeutic Goods Administration had approved Syfovre (intravitreal pegcetacoplan) for the every-other-month treatment of adult patients w...

EssilorLuxottica Acquires Canadian Retinal Camera Maker Cellview Imaging for Undisclosed Amount

Eyewear conglomerate EssilorLuxottica announced Feb. 11 that it had acquired Cellview Imaging, a Canadian startup specializing in ultra-widefield retinal diagnostics. Cellview’s WRI-1 fundus camera...

Appeals Court Upholds Injunctions Blocking Eylea Biosimilars from Samsung Bioepis and Formycon

In a victory for Regeneron, the US Court of Appeals for the Federal Circuit issued a ruling Jan. 29 upholding preliminary injunctions that block Samsung Bioepis and Formycon from launching their ap...

Select US FDA Approvals and Clearances in January 2025

There were no US FDA clearances through the ophthalmic device division using the 510(k) pathway in January 2025, according to the agency’s database. This is a departure from previous months, when i...

US FDA Approves Expanded Label for Izervay to Extend Treatment for GA Beyond 12 Months

Japan’s Astellas Pharma announced Feb. 12 that the US FDA had approved expanded labeling for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy (GA), extending the allowed du...

Oculis Leads Latest Ophthalmic Fundraising with $100 Million Offering

Oculis led recent ophthalmic fundraising efforts with an underwritten $100 million offering to advance its pipeline of ocular candidates. Financing announced in the past four weeks totaled $149.1 m...

NovaBay Gains Shareholder Approval to Sell Eye Care Business

NovaBay, of Emeryville, California, reported Jan. 23 that it had completed the sale of its eye care business to PRN Physician Recommended Nutriceuticals for $11.5 million. The sale includes all the...

Market Scope and the Glaucoma Research Foundation Celebrate 10 Years of Partnership

The handshake agreement over 10 years ago was simple. Market Scope would attend the Glaucoma Research Foundation’s annual three-day Glaucoma 360 meeting, consisting of a fundraising gala, the New H...

Global OCT Market Poised for Strong Growth Thanks to Add-Ons for Combination Devices

The market for optical coherence tomographers (OCT) is not typically driven by disease but by treatments of these diseases. Increased use of intravitreal injections to treat age-related macular deg...

Inventors of OCT to be Inducted Into National Inventors Hall of Fame

The inventors of optical coherence tomography continue to be recognized for their groundbreaking work. James G. Fujimoto, PhD (Massachusetts Institute of Technology), David Huang, MD, PhD (Oregon H...

Harrow, Cencora Partner to Improve Drug Access for Retina Specialists, Patients

Drugmaker Harrow reported Jan. 27 that it had partnered with Cencora to launch a program called “Harrow Cares,” with the goal of making Harrow products iHeezo and Triesence more accessible and affo...

Clinical Trial Updates for Ophthalmic Candidates, February 2025

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Ophthalmology Officials, Doctors, Researchers Feel Effects of Trump’s Sweeping Changes

The US ophthalmic community and larger health care industry have been affected by many policies implemented by the Trump administration since inauguration day on Jan. 20. Among the 3,600 employees ...

Retrospective Study Finds Link Between IVT Injections, Cataract Surgery Complications

Researchers from the Byers Eye Institute at Stanford Health Care in Palo Alto, California, have found that cataract patients with prior intravitreal (IVT) injections face more complications after c...

Study Shows Promise for Genetic Base Editing in Stargardt Disease

Researchers from Switzerland’s Institute of Molecular and Clinical Ophthalmology Basel and Beam Therapeutics say they have developed a gene editing therapy that could potentially treat Stargardt di...

Emerging Companies Pursuing Ophthalmic Indications, February 2025

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

Weekly Surgeon Polls, February 2025

February 2025 Ophthalmic News Briefs

Outlook Therapeutics reported Jan. 16 the final results of the NORSE EIGHT trial of ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet AMD. ONS-5010 demonstrated non-inferiority ...

2024 in Review: Zeiss' Rollout of Micor 700 Shakes Up Cataract Equipment Market in US

German company Carl Zeiss Meditec’s US launch of its Micor 700 handpiece for cataract surgery in 2024 represented a significant step forward in innovation. The Micor offers an entirely new way to s...

Ophthalmology Sees $6.3 Billion in Total Investment in 2024, With 18 M&A Transactions

The ophthalmic market continues to expand and attract funding from a wide variety of investors. Total amounts raised in 2024 reached over $6.3 billion. Venture capital investment in ophthalmology i...

Bausch Kicks off 2025 With Series of Research Deals, Plus an IOL Launch

Bausch + Lomb has recently announced a series of acquisitions and collaborations that it says will bolster its expanding pipeline and help address unmet needs in ophthalmology. It also launched an ...

Select US FDA Approvals and Clearances in December 2024

The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in December 2024, according to the agency’s database. AI Optics gained clearance for its Sentinel ...

Glaukos Submits NDA for Epioxa Epi-On Crosslinking Treatment

Glaukos, of Aliso Viejo, California, reported Dec. 23 that it had submitted its new drug application to the US FDA for Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy,...

US FDA PDUFA Dates for Ophthalmic Drug Candidates

The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.

Aviceda Leads Latest Ophthalmic Fundraising with $207.5 Million Round

Aviceda Therapeutics led recent ophthalmic fundraising efforts with an upsized $207.5 million Series C financing round to support its trials in geographic atrophy. Financing announced in the past f...

2024 in Review: Corporate and Surgeon Rankings of Top 10 Stories

Market Scope asked industry participants and surgeons to select the top story for 2024. Below are their choices. Zeiss’ Rollout of Micor 700 Shakes Up Cataract Equipment Market in US MAC Turmoil Sh...

2024 in Review: MAC Turmoil Shakes Out with Final Policy on Coverage of MIGS

Five of the seven US Medicare Contract Administrators ended a two-year roller coaster ride for the glaucoma surgery market in mid-November by publishing for the second time their final coverage pla...

2024 in Review: Newest PC-IOLs Helped Drive Worldwide Growth in 2024

At least a dozen trifocal and EDOF IOLs were launched in key markets over the past 18 months, spurring worldwide growth and giving presbyopia-correcting lenses a small uptick in their market share ...

2024 in Review: Alcon Expands Its Glaucoma Portfolio With Belkin Acquisition

Alcon completed its acquisition of Israel’s Belkin Vision, maker of the Eagle laser for glaucoma, in July 2024. The purchase expands Alcon’s presence in the glaucoma market; Alcon also offers the H...

2024 in Review: SMILE for Hyperopia, Two Excimer Lasers Lead Refractive Surgical News

Bausch + Lomb announced in January 2024 that the US FDA had approved the Teneo excimer laser platform for LASIK for myopia and myopic astigmatism. It’s the first excimer platform approved in the US...

2024 in Review: LumiThera’s Valeda is First Treatment for Early, Intermediate Dry AMD

The US FDA granted market authorization to LumiThera’s Valeda Light Delivery System as a de novo device on Nov. 4, making it the first treatment of any kind, device or drug, to receive the FDA’s ba...

2024 in Review: Flurry of Eylea Biosimilars Approved; Most Blocked in US by Lawsuits

The FDA was in a hurry in 2024 to get low-cost competitors to Eylea into the US market. Regeneron wasn’t. The FDA approved 12 drugs for ophthalmic indications in 2024, including four generic glauco...

2024 in Review: Change Healthcare and Hoya Data Breaches Highlight Security Risks

The health care and public health sector was the most common ransomware target of any critical US infrastructure sector in 2023 and 2024, according to the FBI. By October 2024, the American Hospita...

2024 in Review: Complement Therapies for GA Fall Short in Bid for Approval in EU

Apellis Pharmaceuticals and Astellas Pharma were unable to build on their regulatory wins in the US to get a victory in Europe. The European Medicines Agency’s Committee for Medicinal Products for ...

2024 in Review: Warburg Pincus Buys Controlling Stake in India’s Appasamy

US-based private equity firm Warburg Pincus re-entered the ophthalmic industry in April 2024 when it bought a controlling stake in India’s Appasamy Associates. Financial details were not disclosed,...

Clinical Trial Updates for Ophthalmic Candidates, January 2025

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

EssilorLuxottica to Acquire Ophthalmic Device Maker Espansione Group

Eyewear conglomerate EssilorLuxottica announced Dec. 16 that it had entered into an agreement to acquire Espansione Group, an Italian maker of light-based ophthalmic devices. Financial details and ...

Carter’s Many Accomplishments Include Saving Millions from Blindness

Former US president Jimmy Carter’s many legacies include saving the of sight of millions of people in less developed regions by providing treatment for onchocerciasis and trachoma through his Carte...

Children’s Hospital Los Angeles Celebrates 100th Luxturna Procedure

Children’s Hospital Los Angeles (CHLA) marked a milestone recently, completing its 100th procedure with the retinal gene therapy Luxturna for Leber congenital amaurosis (LCA)—the most of any center...

Emerging Companies Pursuing Ophthalmic Indications, January 2025

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

Weekly Surgeon Poll, January 2025

Johns Hopkins Scientists Develop Clear OVD That Glows Under Blue Light

Scientists at Johns Hopkins University have developed a clear ophthalmic viscosurgical device (OVD) that turns fluorescent green under blue light, allowing surgeons to verify complete removal of th...

January 2025 Ophthalmic News Briefs

China’s Eyebright Medical announced Jan. 7 that its phakic intraocular lens, the Loong Crystal PR, had received certification as a Class III medical device from the country’s National Medical Produ...

Fall of Restasis Weighs on Dry Eye Revenue in 2024

Restasis continued to act as a brake on prescription dry eye pharmaceutical revenue in 2024 as its US sales kept plummeting. AbbVie reported that sales of the one-time blockbuster drug in the US fe...

Ophthalmic Company Revenue Up 6.3 Percent as Four Companies Report Record-High Quarters

Ophthalmic manufacturer revenue in Q3-2024 totaled $11.8 billion. Revenue increased 6.3 percent from the same quarter in 2023 and increased 0.8 percent from Q2-2024. The total includes Market Scope...

Ophthalmologists Report 5.5 Percent Increase in Q3-2024 Procedure Volume

US ophthalmologists reported that ophthalmic procedures increased 5.5 percent in Q3-2024 compared with the same quarter in 2023, according to Market Scope’s latest survey. Year-over-year performanc...

Asia-Pacific Markets and Lens-Based Procedures Drive Refractive Surgery

Economic conditions continue to be cited as the reason for flat or declining laser-vision correction (LVC)surgery rates in some markets in 2024. However, a shift in refractive surgery types and hig...

Zeiss Gains US Approval for Next-Gen MEL 90 Excimer Laser

Carl Zeiss Meditec gained US FDA approval on Dec. 4 for its MEL 90 excimer laser, the next-generation iteration of its MEL 80 for LASIK surgery. The MEL 90’s US labeling is for correction of myopia...

Bausch + Lomb Acquires Elios Vision, Developer of Excimer Laser Trabeculostomy

Bausch + Lomb announced Dec. 11 that an affiliate had acquired Elios Vision, developer of the Elios excimer laser trabeculostomy procedure for glaucoma. No financial details were disclosed. Elios’ ...

Eyenovia Scraps Phase III Study of Low-Dose Atropine Candidate in Myopia

Eyenovia reported Nov. 15 that it would scrap the Phase III CHAPERONE trial of low-dose atropine in pediatric myopia after an independent data review committee determined that the trial is not meet...

Konan Medical Launches ObjectiveField Perimeter in the US

Konan Medical has launched its ObjectiveField visual field analyzer in the US. The ObjectiveField is an objective perimeter designed to detect visual field abnormalities using pupillary responses. ...

Select US FDA Approvals and Clearances in November 2024

The US FDA granted one clearance through the ophthalmic device division using the 510(k) pathway in November 2024, according to the agency’s database. Novoxel, a newcomer to ophthalmology but not m...

PDUFA Dates for Ophthalmic Drug Candidates

The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.

Topcon Weighing Takeover Bids from Private Equity Firms, Bloomberg Reports

Topcon is considering takeover bids from suitors including the private equity firms KKR & Co. and EQT AB, according to a report Dec. 10 from financial news outlet Bloomberg. The Tokyo-based ophthal...

NIH Joins Push to Fund Breakthroughs in Oculomics Diagnostic Tech

The National Institutes of Health (NIH) is joining the push to fund the development of technologies and biomarkers to diagnose systemic disease through the eye, a field known as oculomics. The NIH ...

US FDA Rejects sNDA for Izervay Seeking Every-Other-Month Dosing

Japan’s Astellas Pharma announced Nov. 19 that the US FDA had issued a complete response letter rejecting its supplemental new drug application (sNDA) for Izervay seeking to expand the drug’s label...

Arctic Vision Licenses Chinese Rights for Xipere to Santen for $85 Million

Clearside Biomedical’s Asia-Pacific partner, Arctic Vision, announced Nov. 7 that it had licensed Chinese commercialization rights for ARVN001, marketed in the US as Xipere, to Santen Pharmaceutica...

Clinical Trial Updates for Ophthalmic Candidates, December 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Cornea Transplant Market Continues to Face Procurement Challenges, as New Approaches on Rise

An estimated 1 million corneas are needed each year to meet the demand of those who could benefit from a transplant. Several factors contribute to the global shortage of corneal tissue. In many cou...

Lineage Leads Latest Ophthalmic Fundraising with $66 Million Offering

Lineage Cell Therapeutics led recent ophthalmic fundraising efforts with a registered direct offering worth up to $66 million to advance its RPE cell therapy candidate. Financing announced in the p...

NYU Langone Health Hails Recovery of Man Over a Year after Landmark Whole Eye Transplant

A surgical team at NYU Langone Health performed the world’s first whole eye and partial-face transplant in May 2023 for Aaron James, who had survived a high-voltage electrical accident at work. Ove...

ARPA-H Pledges $125 Million to Advance Whole Eye Transplantation

The Advanced Research Projects Agency for Health (ARPA-H) announced Dec. 2 that it would pledge up to $125 million from its Transplantation of Human Eye Allografts (THEA) program to advance researc...

CMS Cuts Ophthalmologists’ Procedure Fees, While Raising ASC, HOPD Facility Fees

The Centers for Medicare and Medicaid Services (CMS) published on Nov. 1 the final schedule of Medicare reimbursement fees for physicians in 2025. It also released its facility fee payments for ASC...

MACs Finalize Coverage for Standalone and Combo MIGS Procedures

Five Medicare administrative contractors have issued their final coverage policies for minimally invasive glaucoma surgery, or MIGS, along with more technical billing and coding documents. The poli...

Amgen Launches Eylea Biosimilar Pavblu After Court Win Over Regeneron

Amgen has launched its Eylea biosimilar, Pavblu (aflibercept-ayyh), after a victory in October in its patent fight with Regeneron. Fierce Pharma reported that a trio of US circuit judges on Oct. 22...

Samsung Bioepis, Biogen Gain EU Approval for Aflibercept Biosimilar Known as Opuviz

Korea’s Samsung Bioepis and Biogen, of Cambridge, Massachusetts, announced Nov. 18 that the European Commission had granted marketing authorization for Opuviz (aflibercept-yszy), an Eylea biosimila...

Emerging Companies Pursuing Ophthalmic Indications, December 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

Outlook’s Lytenava Misses Endpoint vs. Ranibizumab in Topline Results

Outlook Therapeutics reported Nov. 27 that its ophthalmic bevacizumab candidate Lytenava (ONS-5010) did not meet its non-inferiority endpoint in topline results from the NORSE EIGHT trial vs. ranib...

Weekly Surgeon Poll, December 2024

December 2024 Ophthalmic News Briefs

Dutch company Ophtec announced Nov. 18 that it had gained CE marking for its Artiplus phakic IOL. The company said the lens offered a solution for relatively young presbyopes, typically in their ea...

Gene Therapies Make Progress Toward Goal of Restoring Sight

Gene therapies again generated buzz at the 2024 AAO meeting—as they have at recent meetings—but perhaps most exciting were reports of a treatment that could partially restore severe vision loss fro...

Zeiss Bolsters Launch of Micor 700 at AAO Meeting With US Surgeons Discussing Adoption

Carl Zeiss Meditec featured its Micor 700 at the 2024 meeting of the American Academy of Ophthalmology in Chicago, Illinois, with presentations that included booth talks by select US surgeons who h...

Ophthalmology Continues to Draw Investors, Eyecelerator Meeting Shows; Retina Stands Out

Ophthalmology remains an appealing investment, driven largely by procedural growth. While hundreds of companies are working toward technology enhancements and innovative therapies, ophthalmology pr...

Preliminary Results Show Prima Implant Allows for Functional Vision in Advanced GA Patients

Science Corporation, of Alameda, California, reported Oct. 22 preliminary results that showed its Prima retinal implant allowed for functional vision in patients who had lost their central visual f...

ARPA-H Seeks Proposals for Tear Duct-Based Diagnostic System, Plus Custom Dosing Platform

ARPA-H announced Oct. 18 that it had launched a new program to develop a tear-based biomarker measurement system that can be inserted into the tear duct to provide continuous health monitoring, pai...

US FDA Asks for Added Data on Neurotech MacTel Candidate, Delays PDUFA Date

Neurotech Pharmaceuticals announced Nov. 8 that it had submitted additional data requested by the US FDA to support its biologic license application (BLA) for NT-501, an encapsulated cell therapy i...

US FDA Grants De Novo Classification to LumiThera’s System for Dry AMD

LumiThera announced Nov. 4 that the US FDA had granted market authorization through the de novo pathway for the Valeda photobio-modulation system for treatment of patients with dry age-related macu...

Select US FDA Approvals and Clearances in October 2024

The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in October 2024, according to the agency’s database. Apple gained clearance for its Digital Prism ...

US FDA Accepts NDA For Lenz’ Presbyopia Drop Candidate

Lenz Therapeutics announced Oct. 21 that the US FDA had accepted its new drug application (NDA) for LNZ100, a once-daily, preservative-free eye drop candidate for presbyopia. The FDA assigned a Pre...

EyePoint Leads Latest Ophthalmic Fundraising with $161 Million Public Offering

EyePoint Pharmaceuticals led recent ophthalmic fundraising efforts with a $161 million upsized underwritten public offering. Proceeds in part will fund clinical development of Duravyu. Financing an...

AI Discussions Surge at Eye Meetings with Aim to Allay Fears, Seek Use Cases

The explosive growth of artificial intelligence has generated both fear and excitement among many in the ophthalmic industry. As technology progresses, so do the conversations at major meetings, wi...

Office-Based Surgery Garners Enthusiasm at 2024 AAO Meeting

Several sessions at the 2024 American Academy of Ophthalmology meeting highlighted the trend of office-based surgery (OBS) and the option of oral sedation among practitioners. The consensus among t...

AAO Puts FDA Deputy Director of Ophthalmology on the Hot Seat

William Boyd, MD, deputy director of ophthalmology at the US FDA’s Office of New Drugs, had a quick answer when asked to name the biggest unmet need in ophthalmology. “We need and want more therapi...

The New Opus Genetics Charts a Course to Gene Therapy Approval

Ben Yerxa, PhD, and George Magrath, MD, say they have a way out of the jungle in which ocular gene therapy development has been trapped since the US FDA approved Luxturna in 2017. “You have to be r...

Are Drugs for GA in the ‘Trough of Disillusionment’?

The celebrations and excitement that accompanied the launch in 2023 of the first two drugs approved in the US for the treatment geographic atrophy (GA) gave way to a hangover and regrets at the 202...

Weighing the Ophthalmic Impact of Boom in GLP-1 Receptor Agonist Treatment

Recent studies indicate that up to 6 percent of the US population is currently taking a GLP-1 receptor agonist, a class of drugs prescribed to help manage blood glucose levels for diabetes and weig...

New Trifocal IOLs Expected to Help the US Resume PC-IOL Growth

Bausch + Lomb’s enVista Envy and J&J Vision’s Odyssey are two new trifocal IOLs that were shown at the 2024 AAO meeting in Chicago. They are expected to help reverse the decline in trifocal IOL sal...

AAO and Eyecelerator Sessions Showcase Latest in Glaucoma Lasers and Surgical Devices

New glaucoma lasers and surgical devices were shown at various venues during the 2024 AAO meeting, including Glaucoma Subspecialty Day and the Eyecelerator meeting. There was also an important upda...

Alcon Looks to Refine Retinal Surgery with Unifeye, Unipexy

Alcon launched at the 2024 AAO meeting two new retinal surgical devices—Unifeye for air-gas exchange and Unipexy for retinopexy. Each is a one-person, hand-held, single-use gas delivery device. The...

Cornea and Eye Banking Forum Looks at Ways to Expand the Donor Pool

Expanding the donor pool was once again top of mind at the 2024 Cornea and Eye Banking Forum, held Oct. 18 in conjunction with the AAO meeting in Chicago, Illinois. The forum, supported by the Eye ...

AAO and Eyenuk Collaborate on AI-Driven DR Screening for Underserved Patients

Eyenuk and the American Academy of Ophthalmology (AAO) reported Oct. 16 that they had teamed up under the AAO’s EyeCare America program to provide eye disease screening for underserved communities ...

Private Practices Key to US Premium Cataract Surgery Market Dominance

The US represents only 5 percent of the global population in 2024, but it accounts for nearly 36 percent of the world’s premium cataract surgery (PCS) market revenue. The US has the latest premium ...

Haag-Streit’s Metis Poised to Join Innovation-Rich and Growing Advanced Microscopes Segment

Haag-Streit revealed its new Metis microscope at the 2024 European Society of Cataract and Refractive Surgeons (ESCRS) meeting and showcased it again at the 2024 AAO meeting. The Metis is specifica...

Clinical Trial Updates for Ophthalmic Candidates, November 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

NovaBay Accepts Higher Offer from PRN to Purchase Assets

NovaBay reported Nov. 6 that it had accepted a higher offer from PRN Physician Recommended Nutriceuticals, LLC, which revised its bid for NovaBay’s Avenova product line after a competing overture f...

Pine Stops Compounding IVT Avastin, Creating Concerns Over Shortage

Pine Pharmaceuticals, of Tonawanda, New York, stopped repackaging Avastin (bevacizumab) for ophthalmic use in October 2024, according to the American Academy of Ophthalmology and American Society o...

Emerging Companies Pursuing Ophthalmic Indications, November 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

November 2024 Ophthalmic News Briefs

Heidelberg Engineering announced Oct. 14 that the US FDA had granted 510(k) clearance to its Flex Module for the Spectralis diagnostic imaging platform. The Flex Module mounts the Spectralis to a m...

Michelle Tarver, MD, PhD, an Ophthalmologist, Named Director of FDA’s CDRH

Michelle E. Tarver, MD, PhD, has been named director of the FDA’s Center for Devices and Radiological Health (CDRH), after serving as acting director since July 2024. She is a board-certified ophth...

Weekly Poll of Surgeons and Eye Doctors, November 2024

First ASCRS Business Summit Breaks Down Premium Surgery’s Role in Practice Success

The first-ever ASCRS Business of Refractive Cataract Surgery (BRiCS) Summit was a two-day course designed to equip practices with the knowledge, resources, and confidence to boost their adoption of...

ESCRS Congress Boasts Record Attendance in Barcelona

Barcelona, Spain, hosted the ESCRS congress for the third time in the 42-year history of the meeting and set a record for the highest attendance to date. Nearly 17 thousand people registered, 60 pe...

EU Regulators Rain on Apellis’ Party at 2024 Euretina Congress

The big news at the 24th Euretina congress was something that didn’t happen at the congress. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) embarrassed Apelli...

Zeiss Begins Broad US Rollout of Micor 700 for Phaco-less Cataract Surgery

Zeiss Medical Technology reported Sept. 26 that it had begun broad US distribution of the Micor 700, the first hand-held device to extract a crystalline lens in cataract surgery without the need fo...

Eyenovia Launches Clobetasol Drops for Postoperative Pain and Inflammation

Eyenovia announced Sept. 26 the US launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%, known as Clobetasol, for postoperative inflammation and pain following oc...

Orasis Leads Latest Ophthalmic Deals with $78 Million Financing

Orasis Pharmaceuticals led recent ophthalmic fundraising efforts with $78 million in Series D and structured capital to support the launch of Qlosi drops for presbyopia. Financing announced in the ...

AbbVie Withdraws EU Marketing Application for Durysta Implant for Glaucoma

Europe’s Committee for Medicinal Products for Human Use (CHMP) announced Sept. 19 that AbbVie had withdrawn its marketing authorization application for the sustained-release glaucoma implant Duryst...

Select US FDA Approvals and Clearances in September 2024

The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in September 2024, according to the agency’s database. Zeiss gained clearance for its combination Y...

NEI Researchers Identify Protein That Clears Cataracts in Animals

Researchers at the National Eye Institute (NEI), working with counterparts in China, have discovered a reversible cataract response in hibernating squirrels that may point toward a nonsurgical trea...

Emerging Companies Pursuing Ophthalmic Indications, October 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

Aurion Biotech Launches Vyznova Corneal Cell Therapy in Japan

Aurion Biotech announced Sept. 24 that it had launched Vyznova (neltependocel), a cell therapy for bullous keratopathy of the cornea, in Japan. Japanese regulators approved Vyznova in March 2023. T...

Retina Specialists Grapple with Functional Endpoints in Clinical Trials

European regulators’ repeated rejection of Syfovre made one thing very clear to retina specialists at Euretina: “Treatment should have an impact on everyday function,” said Thomas Ach, MD (Germany)...

Retina Surgeons at European Meetings Ask, ‘What’s New?’

Experienced retina surgeons among the approximately 8.1 thousand attendees at Euretina in Barcelona, Spain, were underwhelmed by the surgical devices that industry had on display. “There is nothing...

First GA Therapies at Crossroads as EU Regulators Unconvinced Benefits Outweigh Risks

The negative opinion of Syfovre by a key EU regulatory committee has thrown the global marketing plans for complement inhibitors for GA into disarray. Two companies—Apellis Pharmaceuticals and Aste...

ESCRS iNovation Day Looks at MDR Roadblocks, Global Care Issues

The impact of Europe’s new Medical Device Regulation (MDR) on innovation sparked considerable discussion during the ESCRS iNovation Day. The meeting was held Sept. 6 in Barcelona, Spain, ahead of t...

ISOP Meeting Examines Importance of Patient Education and Predictable Outcomes

Patient selection, education, and communication were emphasized throughout the International Society of Presbyopia’s 16th annual conference. The meeting, held Sept. 5 at the Hyatt Regency Hotel in ...

Sustainability: Walking the Walk or Talking the Talk?

Sustainability was a theme for multiple sessions at this year’s ESCRS congress, including one called “Sustainability Without Borders,” hosted by the ESCRS’ Young Ophthalmologists for Sustainability...

Investors Take Temperature of Ophthalmic Market at European Futures Forum

The 2024 Ophthalmology Futures European Forum reviewed the decline in ophthalmic deals in 2024 before offering presenting companies some guidance on how to advance their technology in such an envir...

Hyperopia Treatment Using Lenticule Extraction Showcased to Eager European Ophthalmologists

Dan Reinstein, MD (UK), shared during an overly full symposium at the 2024 ESCRS congress his experience using Zeiss’ SMILE lenticule extraction procedure to treat hyperopic patients. Zeiss is the ...

Cornea Surgeons Examine New Crosslinking Options and Old Debates

Farhad Hafezi, MD, PhD, FARVO (Switzerland), discussed at the 2024 ESCRS congress the goals of the second global consensus on keratoconus, being drafted in 2024. This consensus encompasses feedback...

ESCRS Congress Celebrates 75th Anniversary of First IOL Implantation

The 2024 ESCRS congress celebrated the 75th anniversary of Sir Harold Ridley, MD, implanting the first intraocular lens by telling his story and describing the developments that have occurred since...

2024 ESCRS Congress Puts Spotlight on Latest IOL Designs

New and recently launched IOLs took the spotlight in presentations and on the exhibit floor at the 2024 ESCRS congress. These lenses included the Rayner RayOne Galaxy trifocal, the BVI Serenity Mon...

ViaLase Releases Latest Glaucoma Laser Data at ESCRS Congress

Rick Lewis, MD, chief medical officer at ViaLase, provided an update at the 2024 ESCRS congress on the ViaLuxe glaucoma laser, including the system’s most recent clinical trial results. The ViaLuxe...

Bausch + Lomb Launches Octavius Topo-Guided Treatment at ESCRS Congress

Bausch + Lomb showcased its CE marked Octavius at the 2024 ESCRS Congress. Octavius is a new treatment mode on the Teneo excimer laser that uses data from multiple diagnostic platforms to provide a...

Clinical Trial Updates for Ophthalmic Candidates, October 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Zeiss Invests $24 Million to Expand Production Site in Chesterfield, Missouri

German company Carl Zeiss Meditec opened a new state-of-the-art research and production facility on Oct. 1 in Chesterfield, Missouri, expanding its footprint in the city, which is part of the St. L...

Harrow to Add Nearly 150 Jobs as it Expands in Nashville, Relaunches Triesence

Harrow reported Sept. 25 that it is creating nearly 150 new jobs as it expands its corporate headquarters in Nashville, Tennessee. The move follows the company increasing its total leased space in ...

Europe’s CHMP Recommends Two Aflibercept Biosimilars for Approval

Europe’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on Sept. 19 for two new aflibercept (Eylea) biosimilars—Afqlir from Swiss drugmaker Sandoz and Opuviz, which ...

FTC Sends More Than $1.1 Million to Consumers Misled by LCA-Vision Ads

The Federal Trade Commission (FTC) announced Oct. 3 that it was sending more than $1.1 million in settlement payments to consumers who were misled by deceptive bait-and-switch advertising by LCA-Vi...

October 2024 Ophthalmic News Briefs

Oculus has announced the addition of frequency doubling perimetry (FDP) to its Easyfield VR visual field diagnostic headset. The German ophthalmic diagnostic company, with US headquarters in Arling...

NovaBay to Sell Avenova Products for $9.5 Million as Part of Dissolution Plan

NovaBay Pharmaceuticals has agreed to sell its Avenova products to PRN Physician Recommended Nutriceuticals for $9.5 million in cash, the companies announced Sept. 20. The deal is expected to close...

Weekly Surgeon Poll, October 2024

FDA Names New Leaders at OPEQ and CDHR

Ross Segan, MD, MBA, FACS, has become director of the US FDA’s Office of Product Evaluation and Quality (OPEQ). The office, part of FDA’s Center for Devices and Radiological Health (CDRH), oversees...

2024 World Ophthalmology Congress Draws Thousands to Vancouver

Nearly 3 thousand attendees from 127 countries participated in the 2024 World Ophthalmology Congress (WOC), the biennial meeting of the International Council of Ophthalmology (ICO). Over 500 attend...

Ophthalmic Company Revenue Up 2.6 Percent; Several Public Firms Report Record-High Quarters

Ophthalmic manufacturer revenue in Q2-2024 totaled $11.7 billion. Revenue increased 2.6 percent from the same quarter in 2023 and increased 5.9 percent from Q1-2024. The total includes Market Scope...

Ophthalmologists Report 0.5 Percent Increase in Q2-2024 Procedure Volume

US ophthalmologists reported that ophthalmic procedures increased 0.5 percent in Q2-2024 compared with the same quarter in 2023, according to Market Scope’s latest survey. Year-over-year performanc...

New Drugs for Exudative Retinal Disease Lift Companies Over Patent Cliffs

Roche faced an ophthalmic patent cliff in the US before Regeneron. First, Roche introduced an extended duration alternative to its flagship inhibitor of vascular endothelial growth factor (anti-VEG...

Zeiss Plans to Use Creal's Technology to Reimagine Refractive Exams

Zeiss will integrate Swiss company Creal’s light field display technology into its refractive diagnostic equipment under a collaboration agreement, the two companies reported Sept. 10. Creal descri...

Injectsense Reports First Human Implantation of Ultraminiature IOP Sensor

Injectsense, of Emeryville, California, announced Aug. 27 that it had implanted its first ultraminiature wireless sensor for measuring intraocular pressure (IOP). Glaucoma specialist Juan Mura, MD,...

EC Approves SIFI’s Akantior Drops for Acanthamoeba Keratitis

Italy’s SIFI announced Aug. 26 that the European Commission had approved Akantior (polihexanide 0.08%) drops for the treatment of Acanthamoeba keratitis (AK), a parasitic infection of the eye, in p...

Select US FDA Approvals and Clearances in August 2024

The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in August 2024, according to the agency’s database. Notably, newcomer Intelon Optics received clea...

Meet with Market Scope at the 2024 AAO Meeting

Market Scope will be exhibiting at the 2024 AAO meeting, set for Oct. 18-21 at McCormick Place in Chicago. We will be located at Booth 4903. Contact us to set up a time to discuss any custom resear...

Ophthalmologists Compare Myopia Interventions at WOC as Prevalence Soars

Myopia—especially progression of myopia—is getting increased attention from industry and physicians, as evidenced by the sheer number of studies published on the topic. Additionally, data showing h...

Ophthalmologists Address Challenges of Ocular Trauma During WOC Sessions

Eleven sessions, 52 presentations, and numerous posters at the 2024 World Ophthalmology Congress were dedicated to ocular traumas and emergencies. Conflict zones present ophthalmologists and manufa...

WOC Sessions Raise Concerns Over Physician Health as Burnout Increases

Ron Adelman, MD, MPH, MBA (US), shared findings at the 2024 World Ophthalmology Congress from a study that evaluated the level of burnout among ophthalmologists in the Philippines. Results showed t...

ONL Leads Latest Ophthalmic Fundraising with $65M Series D Round

ONL Therapeutics led recent ophthalmic fundraising efforts with a $65 million Series D round to continue advancing its small-molecule Fas inhibitor for retinal disease. Financing announced in the p...

Oculis Shuts Down Phase III Trial of OCS-01 Due to Third-Party Administrative Error

Swiss company Oculis reported Aug. 27 in its Q2-2024 financial statement that it was shutting down the Phase III OPTIMIZE-2 trial of its OCS-01 eye drop candidate for postsurgical inflammation and ...

Visiox to Merge with Ocuvex to Advance Two Ophthalmic Drug Candidates

Visiox Pharmaceuticals announced Aug. 19 that it had agreed to merge with Ocuvex Therapeutics, a privately held company in New Hyde Park, New York. A Visiox news release said Ocuvex has a pipeline ...

Revenio’s iCare Subsidiary Acquires AI Screening Company Thirona Retina

Finland’s Revenio Group announced Aug. 20 that its iCare subsidiary had assumed ownership of the Dutch artificial intelligence (AI) software company Thirona Retina. iCare had made a minority invest...

OcuDyne Reports Positive Pilot Study Results Using Ophthalmic Artery Angioplasty in GA

OcuDyne, of Brooklyn Park, Minnesota, reported Sept. 9 that it had successfully completed a pilot study using its Optic System to perform ophthalmic artery angioplasty in patients with geographic a...

Emerging Companies Pursuing Ophthalmic Indications, September 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

Light Control May Prevent Eye Damage in Premature Infants, Study Shows

A study in mice at the Science of Light Center at Cincinnati Children’s shows that lighting conditions can change how newborn eyes develop, with darkness fostering the development of more rods, the...

Clinical Trial Updates for Ophthalmic Candidates, September 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Precision Lens and Estate of Paul Ehlen to Pay US $12M over Kickbacks

Minnesota-based ophthalmic distributor Precision Lens and the estate of co-founder Paul Ehlen have agreed to pay the US government $12 million to resolve a case involving kickback payments in vario...

Six States Sue Regeneron over Eylea Drug Price Reporting

The attorneys general for Colorado, Georgia, Michigan, North Carolina, Texas, and Washington have filed suit in federal district court against Regeneron Pharmaceuticals, claiming the drugmaker infl...

September 2024 Ophthalmic News Briefs

Bausch + Lomb is working with Goldman Sachs to explore a sale of the company, the Financial Times reported Sept. 14, with private equity the most likely buyer. The move is being evaluated as a way ...

Weekly Surgeon Poll, September 2024

Livionex’ Cataract Drop Candidate to Advance After New Analysis of Study Results

A new analysis of 2008 clinical study data has given a boost to Livionex’ topical drop candidate for cataracts, the John Moran Eye Center reported Aug. 16. The drop, called C-KAD, is a formulation ...

Zeiss Plans to Use Creal's Technology to Reimagine Refractive Exams

Zeiss will integrate Swiss company Creal’s light field display technology into its refractive diagnostic equipment under a collaboration agreement, the two companies reported Sept. 10. Creal descri...

European Five Market Expected to Grow, Despite MDR Delays

Device makers’ added costs for compliance with the new Medical Device Regulation (MDR) in the European Union (EU) will likely affect the mix of ophthalmic products and companies in the region. Howe...

Wnt Agonists and Optogenetics Create Excitement at 2024 ASRS Meeting in Sweden

Impressive new science and challenging business conditions topped the discussions at the American Society of Retina Specialists’ 2024 annual meeting. The conference took place July 17-20 in Stockho...

Steady Growth Expected in Single-Use Surgical Products, Even With Push to Cut OR Waste

Environmental sustainability programs have grown in scope over the last five years, with major ophthalmic surgery associations joining forces to propose specific actions to reduce the carbon footpr...

Private Equity Ownership of Surgery Centers Continues to Gain Share, Survey Shows

Private equity (PE) investment in ophthalmic practices continues to expand, even as debates over the pros and cons of these investments increase, too. For some practices that were hit hard by COVID...

Ocumension Acquires Rights to Alcon Eye Drops in Exchange for Equity Stake

China’s Ocumension Therapeutics announced Aug. 13 that it would acquire or secure Chinese rights to a portfolio of Alcon dry eye treatments and procedural drops. In exchange, Ocumension will issue ...

Lensar Ends Collaboration with Oertli for Phaco Portion of Ally Cataract System

Lensar has terminated its collaboration agreement with Swiss company Oertli, according to a filing Aug. 5 with the US Securities and Exchange Commission. The two had been developing the Ally Adapti...

NEI Would Fold into Another NIH Institute Under Lawmaker’s Proposed Restructuring

The status of the National Eye Institute (NEI) as a separate unit within the National Institutes of Health (NIH) would come to an end under a proposal by a US House committee chair to consolidate t...

Select US FDA Approvals and Clearances in July 2024

The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in July 2024, according to the agency’s database. Topcon gained clearance for its Maestro2 OCT in c...

MeiraGTx Leads Latest Ophthalmic Fundraising with $50 Million Offering

MeiraGTx led recent ophthalmic fundraising efforts with a $50 million offering of ordinary shares as it moves forward with its extensive pipeline of gene therapy candidates. Financing announced in ...

ViaLase Gains CE Marking for Femtosecond Laser for Glaucoma Treatment

ViaLase announced July 30 that the European Union had granted CE marking for its ViaLase Laser for the treatment of adults with primary open-angle glaucoma. The system uses an OCT-guided femtosecon...

OHSU Researchers Discover Link Between Proteins in Tears, Pain After Eye Surgery

Researchers at Oregon Health & Science University (OHSU) say they have discovered a connection between postsurgical ocular pain and levels of certain proteins found in patients’ tears. Some patient...

Meet with Market Scope at the 2024 ESCRS Congress

Market Scope will be exhibiting at the 2024 ESCRS congress, which is Sept. 6-10 in Barcelona, Spain. We will be located at Stand 6.D12. Contact us to set up a time to discuss any custom research ne...