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Death Toll from Infections Linked to Contaminated Eye Drops Rises to Four
Death Toll from Infections Linked to Contaminated Eye Drops Rises to Four

The US Centers for Disease Control and Prevention (CDC) released an update May 15 on the ongoing Pseudomonas aeruginosa outbreak linked to certain over-the-counter brands of artificial tears. Four ...

Visgenx Developing Preclinical Gene Therapy Candidate for Dry AMD
Visgenx Developing Preclinical Gene Therapy Candidate for Dry AMD

Visgenx is developing a gene therapy candidate for dry age-related macular degeneration (AMD) based on research conducted at the Shiley Eye Institute at the University of California-San Diego. The ...

HuidaGene Therapeutics Appoints Alvin Luk, PhD, as Chief Executive Officer
HuidaGene Therapeutics Appoints Alvin Luk, PhD, as Chief Executive Officer

HuidaGene Therapeutics announced May 24 that it had appointed gene therapy industry veteran Alvin Luk, PhD, MBA, as chief executive officer. Luk has more than 30 years of experience in global drug ...

2023 ARVO Meeting Highlights Research in GA and Batten Disease, New Uses for AI
2023 ARVO Meeting Highlights Research in GA and Batten Disease, New Uses for AI

The 2023 meeting of the Association for Research in Vision and Ophthalmology put ARVO back on track for pre-pandemic attendance numbers. Over 9,800 people registered for the annual event, held in A...

ARVO Sessions on Gene Therapy Reveal Lower Expectations for Segment, but Continuing Interest
ARVO Sessions on Gene Therapy Reveal Lower Expectations for Segment, but Continuing Interest

Gene therapy remained a hot topic at the ARVO meeting, even though it has lost luster in the eyes of some investors and pharmaceutical companies. Researchers at the conference waxed nearly poetic a...

2023 ASCRS Meeting: Ike Ahmed, MD, Proposes Paradigm Shift in Treating Glaucoma Patients
2023 ASCRS Meeting: Ike Ahmed, MD, Proposes Paradigm Shift in Treating Glaucoma Patients

Ike Ahmed, MD, pulled no punches in arguing to fellow surgeons and company officials that the ophthalmic industry is ready for a new approach to glaucoma using initial and step-wise “interventional...

EyePoint Sells Yutiq to Alimera for $82.5 Million Plus Royalties
EyePoint Sells Yutiq to Alimera for $82.5 Million Plus Royalties

EyePoint Pharmaceuticals announced May 18 that it had agreed to sell its uveitis implant Yutiq to Alimera Sciences, a deal worth $82.5 million plus royalties. Under the agreement, Alimera will rece...

US FDA Expands Labeling for Horizon’s Tepezza
US FDA Expands Labeling for Horizon’s Tepezza

Ireland’s Horizon Therapeutics announced April 14 that the US FDA had expanded Tepezza’s labeling to specify its use to treat all thyroid eye disease (TED), regardless of activity or duration. Tepe...

4DMT Leads Latest Ophthalmic Fundraising with $138 Million Public Offering
4DMT Leads Latest Ophthalmic Fundraising with $138 Million Public Offering

4D Molecular Therapeutics led recent fundraising efforts by ophthalmic companies with a $138 million upsized public offering of common stock. Funding announced in the past four weeks totaled $456.4...

Select US FDA Approvals and Clearances in April 2023
Select US FDA Approvals and Clearances in April 2023

The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in April 2023, according to the agency’s database. Notably, J&J Vision gained market clearance for...

US FDA Approves Miebo Drops for Dry Eye from Bausch + Lomb, Novaliq
US FDA Approves Miebo Drops for Dry Eye from Bausch + Lomb, Novaliq

Bausch + Lomb and Novaliq announced May 18 that the US FDA had approved Miebo (perfluorohex-yloctane ophthalmic solution), formerly NOV03, for the signs and symptoms of dry eye. The companies said ...

EyePoint Sells Yutiq to Alimera for $82.5 Million Plus Royalties
EyePoint Sells Yutiq to Alimera for $82.5 Million Plus Royalties

EyePoint Pharmaceuticals announced May 18 that it had agreed to sell its uveitis implant Yutiq to Alimera Sciences, a deal worth $82.5 million plus royalties. Under the agreement, Alimera will rece...

Lumevoq’s Withdrawal in Europe is Latest Gene Therapy Setback
Lumevoq’s Withdrawal in Europe is Latest Gene Therapy Setback

Disappointing news keeps piling up for the commercialization of gene therapies in ophthalmology. Paris-based GenSight Biologics announced in April that it had withdrawn the marketing authorization ...

Japanese Drugmaker Astellas to Acquire Iveric Bio for $5.9 Billion
Japanese Drugmaker Astellas to Acquire Iveric Bio for $5.9 Billion

Japan-based Astellas Pharma announced April 30 that it is acquiring Iveric Bio, developer of a late-stage geographic atrophy (GA) drug candidate, for $5.9 billion. The companies said they entered i...

ARVO Program Underlines Continuing Search for Better Drug Delivery
ARVO Program Underlines Continuing Search for Better Drug Delivery

The search for alternatives to monthly intravitreal injection of retinal drugs continues to be well represented in ARVO presentations. The classification of papers sometimes is complicated when the...

CHAMP Study Draws Attention to Atropine Drop Results
CHAMP Study Draws Attention to Atropine Drop Results

Much of the buzz in myopia research at the 2023 ARVO meeting centered around atropine. The pre-eminent paper reported results from the CHAMP study. CHAMP was the first randomized, controlled, maske...

ARVO Meeting Serves Up Potpourri of New AMD Research
ARVO Meeting Serves Up Potpourri of New AMD Research

Research into therapeutic approaches that go beyond existing anti-VEGFs was one important area of AMD research featured at ARVO. Philip Rosenfeld, MD, PhD, called Valitor’s multivalent protein conj...

Australian Group Pioneers New Way to Improve Performance of Retinal Prostheses
Australian Group Pioneers New Way to Improve Performance of Retinal Prostheses

The Centre for Eye Research Australia (CERA) has brought new hope to the idea that retinal prostheses can restore meaningful vision to people who have gone blind. Poor performance has kept retinal ...

2023 ASCRS Meeting Draws 5,300, with 250 Exhibitor Booths
2023 ASCRS Meeting Draws 5,300, with 250 Exhibitor Booths

The American Society of Cataract and Refractive Surgery said 5,300 individuals had attended the 2023 meeting, not including exhibitors, with around 3,350 ophthalmologists, according to initial tota...

Vance Thompson Encourages Cataract Surgeons to Adopt PC-IOLs
Vance Thompson Encourages Cataract Surgeons to Adopt PC-IOLs

Vance Thompson, MD, a leading expert in refractive and cataract surgery, gave this year’s Steinert Lecture at the 2023 meeting of the American Society of Cataract and Refractive Surgery. Thompson d...

Honoring the Gift: CorneaGen Aims to Get More from Every Donated Cornea
Honoring the Gift: CorneaGen Aims to Get More from Every Donated Cornea

Cornea surgeons and CorneaGen are leading the way in getting more from each donor graft. Seattle-based CorneaGen discussed its new CTAK (cornea tissue addition keratoplasty) product at its booth at...

Cornea Endothelial Treatment Gap Narrows as Transplant Alternatives Advance
Cornea Endothelial Treatment Gap Narrows as Transplant Alternatives Advance

Cell therapies, particularly Aurion Biotech’s AURN001, garnered excitement from industry and clinicians at the 2023 ASCRS meeting. As John Berdahl, MD, said during the Cornea Subspecialty Day progr...

J&J Vision Launches Elita femtosecond Laser at ASCRS Meeting
J&J Vision Launches Elita femtosecond Laser at ASCRS Meeting

Anticipation has been building as Johnson & Johnson Vision begins commercialization of its new femtosecond refractive laser. Over 100 ophthalmologists gathered around the company’s booth at the 202...

Presbyopic Patient Satisfaction is Top of Mind as Vuity Prescriptions Soften
Presbyopic Patient Satisfaction is Top of Mind as Vuity Prescriptions Soften

Presbyopia drops continued to be a hot topic at the 2023 ASCRS meeting. With one commercial product available and others close to launch, this meeting allowed providers to better discern the key di...

Inaugural Digital Day at ASCRS Meeting Highlights Potential Hurdles and Benefits of Ophthalmic Uses
Inaugural Digital Day at ASCRS Meeting Highlights Potential Hurdles and Benefits of Ophthalmic Uses

The Digital Ophthalmic Society (DOS) sponsored the first-ever Digital Day on May 5 in conjunction with Subspecialty Day at 2023 ASCRS meeting. Digital Day was designed to create a collaborative env...

Emerging Companies Pursuing Ophthalmic Indications, May 2023
Emerging Companies Pursuing Ophthalmic Indications, May 2023

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease. Company Location About PinotBio Suwon, South Korea The company is developing NTX-101, an 11β...

US FDA Approves Eyenovia’s Mydcombi for Pupil Dilation Via Optejet Dispenser
US FDA Approves Eyenovia’s Mydcombi for Pupil Dilation Via Optejet Dispenser

Eyenovia announced May 8 that the US FDA had approved Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditi...

Akorn Issues Recall of All Products in Wake of Company Shutdown in February
Akorn Issues Recall of All Products in Wake of Company Shutdown in February

The US FDA announced April 26 that Akorn had issued a voluntary nationwide recall of its products, after the company shut down all its US sites on Feb. 23 and laid off its workforce. The company sa...

Clinical Trial Updates for Ophthalmic Candidates, May 2023
Clinical Trial Updates for Ophthalmic Candidates, May 2023

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements. Date Company Candidate, Indication Milestone Notes May 7 Innovent Biologics IBI311 (anti-IGF...

Weekly Corporate and Surgeon Poll, May 2023
Weekly Corporate and Surgeon Poll, May 2023

May 2023 Ophthalmic News Briefs
May 2023 Ophthalmic News Briefs

Denmark’s Norlase announced May 5 that it had received both US FDA 510(k) clearance and CE marking in Europe for its Echo green pattern laser photocoagulator. Norlase says the Echo is “truly portab...

2023 Ophthalmic Meetings Calendar

Organization Status Date Location More Information Hawaiian Eye and Retina 2023 Physical meeting Jan. 14-20 Kauai, Hawaii https://www.healio.com/meeting/ hawaiianeyemeeting/home Glaucoma 360 Physic...

US FDA Approves Miebo Drops for Dry Eye from Bausch + Lomb, Novaliq
US FDA Approves Miebo Drops for Dry Eye from Bausch + Lomb, Novaliq

Bausch + Lomb and Novaliq announced May 18 that the US FDA had approved Miebo (perfluorohexyloctane ophthalmic solution), formerly NOV03, for the signs and symptoms of dry eye. The companies said M...

FTC Sues to Block Amgen Acquisition of Horizon, Says Deal Would Stifle Competition
FTC Sues to Block Amgen Acquisition of Horizon, Says Deal Would Stifle Competition

The US Federal Trade Commission (FTC) announced May 16 that it has sued in federal court to block Amgen’s proposed $27.8 billion acquisition of Horizon Therapeutics. The FTC argued that the deal wo...

Q1-2023 Ophthalmic Revenue Roundup for Harrow, Iridex, Alimera, and LENSAR
Q1-2023 Ophthalmic Revenue Roundup for Harrow, Iridex, Alimera, and LENSAR

Harrow, of Nashville, Tennessee, reported May 11 that Q1-2023 revenue was $26.1 million, a record amount for the company and an 18 percent increase over $22.1 million in Q1-2022. The company reaffi...

US FDA Approves C. Light’s Retitrack Retinal Eye Movement Monitor
US FDA Approves C. Light’s Retitrack Retinal Eye Movement Monitor

C. Light Technologies announced May 11 that its retinal eye movement monitor, dubbed Retitrack, had received 510(k) clearance from the US FDA. C. Light, of Medford, Massachusetts, is a neurotech an...

Ray Therapeutics Closes Oversubscribed $100M Series A Financing
Ray Therapeutics Closes Oversubscribed $100M Series A Financing

Ray Therapeutics announced May 16 that it had closed an upsized and oversubscribed $100 million Series A financing round led by Novo Holdings. Ray, of San Francisco, said the funding would go towar...

Invirsa Completes Enrollment in Phase I/IIa Study of Dry Eye Candidate
Invirsa Completes Enrollment in Phase I/IIa Study of Dry Eye Candidate

Invirsa, of Columbus, Ohio, announced May 15 that it had completed enrollment in a Phase I/IIa trial of INV-102, its eye drop candidate for dry eye. The company said subjects had moderate dry eye, ...

US FDA Approves Eyenovia’s Mydcombi for Pupil Dilation Via Optejet Dispenser
US FDA Approves Eyenovia’s Mydcombi for Pupil Dilation Via Optejet Dispenser

Eyenovia announced May 8 that the US FDA had approved Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditi...

Q1-2023 Ophthalmic Revenue Roundup for Alcon, Immunocore, Sight Sciences, Apellis, and Three Others
Q1-2023 Ophthalmic Revenue Roundup for Alcon, Immunocore, Sight Sciences, Apellis, and Three Others

Alcon reported May 9 that its Q1-2023 net sales were $2.3 billion, a 7 percent increase (+11 percent cc) over $2.2 billion in Q1-2022. Surgical net sales totaled $1.30 billion, consisting of $427 m...

Tennessee Ophthalmology Practices to Pay $17M to Settle Anti-Kickback, False Claims Case
Tennessee Ophthalmology Practices to Pay $17M to Settle Anti-Kickback, False Claims Case

SouthEast Eye Specialists, SouthEast Eye Surgery Center, and the Eye Surgery Center of Chattanooga have agreed to pay the United States and Tennessee $17 million to resolve allegations that they vi...

US FDA Accepts Glaukos’ NDA for iDose TR Implant for Glaucoma
US FDA Accepts Glaukos’ NDA for iDose TR Implant for Glaucoma

Glaukos announced May 5 that the US FDA had accepted the new drug application (NDA) for its iDose TR (travoprost intraocular implant) in glaucoma and set a Prescription Drug User Fee Act (PDUFA) ta...

US FDA Accepts Supplemental BLA for Genentech’s Vabysmo in RVO
US FDA Accepts Supplemental BLA for Genentech’s Vabysmo in RVO

Genentech, a member of the Roche Group, announced May 9 that the US FDA had accepted its supplemental biologics license application for Vabysmo (faricimab-svoa) for the treatment of macular edema f...

Formosa, AimMax Submit NDA to US FDA for Postsurgical Pain and Inflammation Candidate
Formosa, AimMax Submit NDA to US FDA for Postsurgical Pain and Inflammation Candidate

Formosa Pharmaceuticals and AimMax Therapeutics announced May 4 that they had submitted a new drug application (NDA) to the US FDA for APP13007, a novel ophthalmic nanosuspension of the corticoster...

Alvotech Makes Deal with Polifarma to Develop and Market Eylea Biosimilar in Turkey
Alvotech Makes Deal with Polifarma to Develop and Market Eylea Biosimilar in Turkey

Biosimilar company Alvotech, of Reykjavik, Iceland, announced May 10 that it had entered into an agreement with Polifarma for the commercialization in Turkey of AVT06, Alvotech’s Eylea (aflibercept...

Norlase Receives US FDA 510(k) Clearance and CE Mark Approval for Echo Green Pattern Laser
Norlase Receives US FDA 510(k) Clearance and CE Mark Approval for Echo Green Pattern Laser 

Denmark’s Norlase announced May 5 that it had received both US FDA 510(k) clearance and CE marking in Europe for its Echo green pattern laser photocoagulator. Norlase says the Echo is “truly portab...

Japanese Drugmaker Astellas to Acquire Iveric Bio for $5.9 Billion
Japanese Drugmaker Astellas to Acquire Iveric Bio for $5.9 Billion

Japan-based Astellas Pharma announced April 30 that it is acquiring Iveric Bio, developer of a late-stage geographic atrophy (GA) drug candidate, for $5.9 billion. The companies said they entered i...

Q1-2023 Ophthalmic Revenue Roundup for Regeneron, Bausch + Lomb, and Three Others
Q1-2023 Ophthalmic Revenue Roundup for Regeneron, Bausch + Lomb, and Three Others

Regeneron, of Tarrytown, New York, reported May 4 that its Q1-2023 US revenue for Eylea was $1.43 billion, a 6 percent decline from $1.52 billion in Q1-2022. The company said the decrease primarily...

Centricity Vision’s Next-Generation ZeptoLink Gains US Clearance
Centricity Vision’s Next-Generation ZeptoLink Gains US Clearance

Centricity Vision, of Carlsbad, California, reported May 3 that its next-generation ZeptoLink IOL Positioning System had gained US FDA 510(k) clearance. The platform now integrates with any phacoem...

US FDA OKs Phase I/II Trial of Atsena’s Gene Therapy Candidate for X-linked Retinoschisis
US FDA OKs Phase I/II Trial of Atsena’s Gene Therapy Candidate for X-linked Retinoschisis

Atsena Therapeutics announced May 1 that the US FDA had cleared its investigational new drug (IND) application for a Phase I/II clinical trial of ATSN-201, a gene therapy candidate for X-linked ret...

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