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Topcon, RadiusXR, and Glaukos Team Up to Launch Inspire VR Perimeter Headset
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 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
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
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
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
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
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
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
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
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
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
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
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 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
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
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 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
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
Weekly Corporate and Surgeon Poll, March 2025

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

US FDA Accepts NDA for Sydnexis’ Low-Dose Atropine for Myopia, Sets PDUFA Date of Oct. 23, 2025
US FDA Accepts NDA for Sydnexis’ Low-Dose Atropine for Myopia, Sets PDUFA Date of Oct. 23, 2025

Sydnexis, of Del Mar, California, reported March 11 that the US FDA had accepted its new drug application for SYD-101, a low-dose atropine eye drop to slow the progression of pediatric myopia. The ...

2024 Ophthalmic Revenue Roundup for Amgen and Biogen
2024 Ophthalmic Revenue Roundup for Amgen and Biogen

Amgen, of Thousand Oaks, California, reported Feb. 4 that its 2024 revenue for Tepezza was $1.85 billion. 2024 was the first full year of Tepezza sales for Amgen after the company closed its acquis...

Study of Corneal Stem Cell Transplant Shows Vision Restored After Blinding Eye Injuries
Study of Corneal Stem Cell Transplant Shows Vision Restored After Blinding Eye Injuries

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...

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

Early Study Shows Promise for Head-Mounted Retinal Surgery Robot
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...

Deerfield Sues Alcon over Latest Moves to Prevent Aurion IPO
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...

US FDA Grants Fast Track Status to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate
US FDA Grants Fast Track Status to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate

Atsena Therapeutics announced March 12 that the US FDA had granted fast track designation to ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS). The candidate previously receive...

US FDA Approves Neurotech’s Cell Therapy Implant for MacTel
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...

2024 Ophthalmic Revenue Roundup for Apellis, Immunocore, Sight Sciences, Ocular Therapeutix, Lensar, and ANI
2024 Ophthalmic Revenue Roundup for Apellis, Immunocore, Sight Sciences, Ocular Therapeutix, Lensar, and ANI

Apellis Pharmaceuticals, of Waltham, Massachusetts, reported Feb. 28 that its 2024 net product revenue for Syfovre was $611.8 million, a 122.3 percent increase over $275.2 million in 2023. The comp...

MediPrint Ophthalmics Adds HA-Eluting Contact Lens to Pipeline
MediPrint Ophthalmics Adds HA-Eluting Contact Lens to Pipeline

MediPrint Ophthalmics announced March 5 that it would expand its clinical program to address contact lens dropout due to discomfort with a drug-eluting contact lens that continuously delivers hyalu...

Outlook Resubmits BLA to US FDA for Ophthalmic Bevacizumab (Lytenava)
Outlook Resubmits BLA to US FDA for Ophthalmic Bevacizumab (Lytenava)

Outlook Therapeutics reported Feb. 28 that it had resubmitted its biologics license application (BLA) to the US FDA for ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet age-rel...

US FDA Approves ANI Pharmaceuticals’ Cortrophin Gel in Prefilled Syringe
US FDA Approves ANI Pharmaceuticals’ Cortrophin Gel in Prefilled Syringe

ANI Pharmaceuticals announced March 3 that the US FDA had approved a prefilled syringe of its purified Cortrophin gel. Among its many indications, the treatment targets acute and chronic inflammato...

Avirmax Initiates IND-Enabling Studies of Dry AMD Triple-Gene Therapy Candidate
Avirmax Initiates IND-Enabling Studies of Dry AMD Triple-Gene Therapy Candidate

Avirmax Biopharma announced Feb. 28 that it had begun investigational new drug (IND) enabling studies of ABI-201, a viral vector that delivers three genes with the goal of preventing retinal pathog...

Japanese Regulators Grant Orphan Drug Status to HanAll’s Batoclimab in Active Thyroid Eye Disease
Japanese Regulators Grant Orphan Drug Status to HanAll’s Batoclimab in Active Thyroid Eye Disease

South Korea’s HanAll Biopharma announced March 6 that Japanese regulators had granted orphan drug designation to batoclimab, a subcutaneous anti-FcRn treatment being developed for autoimmune diseas...

Ocugen’s Gene Therapy Candidates for GA and Stargardt Gain Advanced Therapy Status in Europe
Ocugen’s Gene Therapy Candidates for GA and Stargardt Gain Advanced Therapy Status in Europe

Ocugen announced March 3 that European regulators had granted advanced therapy medicinal product status to OCU410 and OCU410ST, the company’s subretinal gene therapy candidates for geographic atrop...

US FDA Accepts NDA for Glaukos’ Epioxa, Sets PDUFA Date of Oct. 20, 2025
US FDA Accepts NDA for Glaukos’ Epioxa, Sets PDUFA Date of Oct. 20, 2025

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...

2024 Ophthalmic Revenue Roundup for Alcon, Glaukos, Tarsus, and RxSight
2024 Ophthalmic Revenue Roundup for Alcon, Glaukos, Tarsus, and RxSight

Alcon reported Feb. 25 that its full year 2024 net sales totaled $9.8 billion, a 5 percent increase (+6 percent cc) over $9.4 billion in 2023. Q4-2024 sales were $2.5 billion, a 6 percent increase ...

Alcon Launches Systane Pro Preservative-Free Drops for Dry Eye in US
Alcon Launches Systane Pro Preservative-Free Drops for Dry Eye in US

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...

STAAR Appoints Stephen C. Farrell as President, CEO; Tom Frinzi to Remain as Adviser Through January 2026
STAAR Appoints Stephen C. Farrell as President, CEO; Tom Frinzi to Remain as Adviser Through January 2026

STAAR Surgical announced Feb. 26 that Stephen C. Farrell, current lead independent director of the company’s board, has been appointed president and CEO. Farrell succeeds ophthalmic industry vetera...

Chinese Regulators Approve Zeiss’ VisuMax 800 with SMILE Pro Software
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...

Formycon, Klinge Gain UK Approval for Eylea Biosimilar Under Brand Name Ahzantive
Formycon, Klinge Gain UK Approval for Eylea Biosimilar Under Brand Name Ahzantive

German companies Formycon and Klinge Biopharma announced Feb. 25 that the UK’s Medicines and Healthcare Products Regulatory Agency had granted marketing authorization for their Eylea biosimilar und...

Seonix Bio Launches SightScore Saliva Test for Glaucoma Risk in US
Seonix Bio Launches SightScore Saliva Test for Glaucoma Risk in US

Seonix Bio announced Feb. 20 the US launch of SightScore, the first commercially available clinical polygenic risk score testing service for primary open-angle glaucoma. Seonix, an Australian compa...

Chinese Regulators Accept NDA for Arcatus (Xipere) in Uveitic Macular Edema
Chinese Regulators Accept NDA for Arcatus (Xipere) in Uveitic Macular Edema

Clearside Biomedical announced Feb. 20 that Chinese regulators had accepted for review the new drug application (NDA) filed by Clearside’s Asia-Pacific partner, Arctic Vision, for Arcatus, known as...

Opus Gains FDA Fast Track Status for Phentolamine Drops for Night Driving Impairment
Opus Gains FDA Fast Track Status for Phentolamine Drops for Night Driving Impairment

Opus Genetics announced Feb. 26 that the US FDA had granted fast track designation to the company’s phentolamine eye drop candidate for night driving impairment in keratorefractive patients. Ocuphi...

New World Medical Gains US 510(k) Clearance for the Via360 Viscodilation System for Glaucoma
New World Medical Gains US 510(k) 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...

Bausch + Lomb Posts 2024 Revenue of $4.8 Billion
Bausch + Lomb Posts 2024 Revenue of $4.8 Billion

Bausch + Lomb reported Feb. 19 that its 2024 revenue totaled $4.8 billion, a 16 percent increase (+17 percent cc) over $4.1 billion in 2023. The company’s Q4-2024 revenue was $1.3 billion, a 9 perc...

Alcon Announces US Launch of Voyager DSLT for Glaucoma
Alcon Announces US Launch of Voyager DSLT for Glaucoma

Alcon announced Feb. 19 the full US commercial launch of the Voyager laser for direct selective laser trabeculoplasty (DSLT). The company said attendees of the American Glaucoma Society meeting in ...

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

Celltrion Gains EU Approval for Aflibercept Biosimilar Branded Eydenzelt
Celltrion Gains EU Approval for Aflibercept Biosimilar Branded Eydenzelt

South Korea’s Celltrion announced Feb. 18 that the European Commission had granted marketing authorization to Eydenzelt, an aflibercept (Eylea) biosimilar. Eydenzelt (40 mg/mL solution for injectio...

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