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Precise Bio Treats First Patient With 3D Bioprinted Corneal Implant
Precise Bio Treats First Patient With 3D Bioprinted Corneal Implant

Precise Bio announced Nov. 19 that the first patient had been treated with PB-001, the company’s 3D bioprinted corneal implant candidate, in a Phase I clinical trial. The legally blind patient was ...

Topcon Gains US 510(k) Clearance for Omnia 4-in-1 Diagnostic Device
Topcon Gains US 510(k) Clearance for Omnia 4-in-1 Diagnostic Device

Topcon Healthcare announced on Nov. 18 the FDA 510(k) clearance and US commercial launch of Omnia, an automated four-in-one diagnostic device that integrates objective refraction, keratometry, tono...

iOR Partners Rolls Out MD-OD Office-Based Collaboration Model
iOR Partners Rolls Out MD-OD Office-Based Collaboration Model

Kansas City, Missouri-based iOR Partners reported Nov. 12 that it was rolling out a newcollaboration model designed to bring together ophthalmologists (MDs) and optometrists (ODs). iOR Partners dev...

Harrow Takes Unconventional Path, Sees Soaring Revenue Growth
Harrow Takes Unconventional Path, Sees Soaring Revenue Growth

Harrow is making waves in ophthalmology. Product acquisitions, rapid growth, and breaking with convention are all part of CEO Mark Baum’s blueprint for building the first major new US ophthalmic co...

US FDA Approves Eylea HD for RVO, Plus Monthly Dosing in All Approved Indications
US FDA Approves Eylea HD for RVO, Plus Monthly Dosing in All Approved Indications

Regeneron Pharmaceuticals announced Nov. 19 that the US FDA had approved Eylea HD (aflibercept 8 mg) for macular edema following retinal vein occlusion (RVO), with dosing up to every eight weeks af...

Cellution Launches AmnioPlast Allografts in US for Ocular Surface Repair
Cellution Launches AmnioPlast Allografts in US for Ocular Surface Repair

Cellution Biologics announced Nov. 19 the US launch of its AmnioPlast 1 monolayer and AmnioPlast Double dual-layer dehydrated amnion membrane allografts for ocular surface repair. The Roswell, Geor...

New Brain Stimulation Approach Improves Vision Recovery After Stroke
New Brain Stimulation Approach Improves Vision Recovery After Stroke

Researchers at Switzerland-based Ecole Polytechnique Fédérale de Lausanne reported Nov. 17 that they had successfully tested a new brain stimulation treatment to improve vision recovery in stroke p...

Two Leading Eye Banks Based in Southeastern US Announce Merger
Two Leading Eye Banks Based in Southeastern US Announce Merger

Two US eye banks, Advancing Sight Network and Miracles In Sight, announced Nov. 6 that they would merge and begin operating as one on Jan. 1, 2026. Advancing Sight Network, of Birmingham, Alabama, ...

Moria’s New Corneal Tissue Storage Medium is First in Decades
Moria’s New Corneal Tissue Storage Medium is First in Decades

Moria aims to enhance the landscape of corneal tissue storage as it launches the first new product in the category in 30 years. “Xtra4 is the most advanced corneal storage medium we’ve ever develop...

Medicare Updates Offer Mixed Bag for Eye Doctors, AAO Policy Experts Say
Medicare Updates Offer Mixed Bag for Eye Doctors, AAO Policy Experts Say

Policy experts provided ophthalmologists at the 2025 AAO meeting with guidance on proposed changes to Medicare reimbursement for 2026; those changes have since been finalized and formally announced...

Lilly Makes Foray into Ophthalmic Gene Therapies with Adverum, MeiraGTx Deals
Lilly Makes Foray into Ophthalmic Gene Therapies with Adverum, MeiraGTx Deals

Drugmaker Eli Lilly made two significant moves recently to enter the arena of ophthalmic gene therapies, acquiring Adverum Biotechnologies in a deal worth up to $262 million, and licensing technolo...

Amsurg Acquires ASC in South Carolina, Expanding Footprint in State
Amsurg Acquires ASC in South Carolina, Expanding Footprint in State

Amsurg, of Nashville, Tennessee, reported Oct. 28 that it had acquired Surgery Center of Conway, in Conway, South Carolina, its fourth center in the state. Amsurg, a leader in ASC services, said th...

Select US FDA Approvals and Clearances in October 2025
Select US FDA Approvals and Clearances in October 2025

The US FDA’s ophthalmic device division granted clearance to one device using the 510(k) pathway in October 2025, according to the agency’s database. OD-OS gained clearance for its Navilas 577sl la...

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.

AAVantgarde Leads Latest Ophthalmic Fundraising with $141 Million in Series B
AAVantgarde Leads Latest Ophthalmic Fundraising with $141 Million in Series B

AAVantgarde Bio led recent ophthalmic fundraising efforts with $141 million in Series B funding to advance its retinal gene therapy pipeline. Financing announced in the past four weeks totaled $488...

STAAR Solicits New Bids Under Amended Deal with Alcon, Moves Shareholder Vote to Dec. 19
STAAR Solicits New Bids Under Amended Deal with Alcon, Moves Shareholder Vote to Dec. 19

STAAR Surgical reported Nov. 7 that it had amended its merger agreement with Alcon to allow STAAR to solicit new buyers for 30 days under a new “go-shop” period ending Dec. 6. STAAR also delayed to...

Mallinckrodt Spins Off Generics Business, Rebrands as Keenova
Mallinckrodt Spins Off Generics Business, Rebrands as Keenova

Drugmaker Mallinckrodt announced Nov. 10 that it had completed the planned spinoff of its Par Health generic pharmaceuticals and sterile injectables businesses and had rebranded as Keenova Therapeu...

Numerous New Products Showcased at 2025 AAO Meeting
Numerous New Products Showcased at 2025 AAO Meeting

More than 16 thousand people attended the 2025 meeting of the American Academy of Ophthalmology, held Oct. 17-20 at the Orange County Convention Center in Orlando, Florida. Sixty percent of them we...

Interest Builds for Presbyopia Drops, as Third Therapy Hits Market
Interest Builds for Presbyopia Drops, as Third Therapy Hits Market

Lenz Therapeutics’ newly launched Vizz was met with enthusiasm at the 2025 meeting of the 2025 AAO meeting, as attendees crowded the company’s large booth. Lenz made Vizz available commercially in ...

AAO Speakers Continue to Promote Glaucoma Laser Innovation and Effectiveness
AAO Speakers Continue to Promote Glaucoma Laser Innovation and Effectiveness

The 2025 AAO meeting underscored the importance of laser therapy in glaucoma and highlighted emerging technology that aims to shape the future of the market. Selective laser trabeculoplasty (SLT) t...

2026-2027 Ophthalmic Meetings Calendar
2026-2027 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.

How Two CMS Cuts Affect Final 2026 Physician Fee Schedule
How Two CMS Cuts Affect Final 2026 Physician Fee Schedule

Two reductions to parts of the formula used to calculate physicians’ Medicare procedure fees in 2026 are lowering reimbursement significantly for common ophthalmic procedures. The formula involves ...

Novartis Offloads Rights to Beovu, Lucentis in South Korea, China
Novartis Offloads Rights to Beovu, Lucentis in South Korea, China

Swiss drugmaker Novartis made deals in October to offload distribution rights to retinal treatments Beovu (brolucizumab) and Lucentis (ranibizumab) in South Korea and mainland China. Japan’s Santen...

Clinical Trial Updates for Ophthalmic Candidates, November 2025
Clinical Trial Updates for Ophthalmic Candidates, November 2025

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

US FDA Rejects Sydnexis’ Low-Dose Atropine Drop for Pediatric Myopia
US FDA Rejects Sydnexis’ Low-Dose Atropine Drop for Pediatric Myopia

Sydnexis announced Oct. 23 that the US FDA had issued a complete response letter rejecting the company’s new drug application (NDA) for SYD-101, a low-dose atropine formulation to slow the progress...

Richard Pazdur, MD, to Lead US FDA’s Center for Drug Evaluation and Research
Richard Pazdur, MD, to Lead US FDA’s Center for Drug Evaluation and Research

The US FDA reported Nov. 11 that oncologist Richard Pazdur, MD, had been named director of the Center for Drug Evaluation and Research (CDER). Pazdur is a 26-year veteran of the FDA and the foundin...

Weekly Ophthalmologist and Optometrist Poll, November 2025
Weekly Ophthalmologist and Optometrist Poll, November 2025

November 2025 Ophthalmic News Briefs
November 2025 Ophthalmic News Briefs

VEO Ophthalmics announced Oct. 16 that the VisionOne VR Visual Field platform is now available in the US through a strategic partnership with Switzerland’s PeriVision. No financial details about th...

UK High Court Ruling Paves Way for Launch of Alvotech’s Aflibercept Biosimilar
UK High Court Ruling Paves Way for Launch of Alvotech’s Aflibercept Biosimilar

Iceland’s Alvotech announced Nov. 10 that the UK High Court had rejected an injunction from Eylea marketers Regeneron and Bayer against Alvotech and its contract manufacturing organization. The dec...

FDA Clears Way for US Patient to Receive GenSight’s Lumevoq for LHON
FDA Clears Way for US Patient to Receive GenSight’s Lumevoq for LHON

France’s GenSight Biologics announced Oct. 30 that the FDA had granted permission for a single patient in the US to be treated with GS010, also known as Lumevoq, GenSight’s intravitreal gene therap...

Emerging Companies Pursuing Ophthalmic Indications, November 2025
Emerging Companies Pursuing Ophthalmic Indications, November 2025

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

Lilly, MeiraGTx Sign Ophthalmic Gene Therapy Deal Worth Up to $475 Million
Lilly, MeiraGTx Sign Ophthalmic Gene Therapy Deal Worth Up to $475 Million

MeiraGTx Holdings announced Nov. 10 that it granted drugmaker Eli Lilly exclusive worldwide rights to its AAV-AIPL1 gene therapy program targeting Leber congenital amaurosis 4 (LCA4). Lilly will al...

Q3-2025 Ophthalmic Revenue Roundup for Alcon, Santen, Immunocore, STAAR, Harrow, and Five Others
Q3-2025 Ophthalmic Revenue Roundup for Alcon, Santen, Immunocore, STAAR, Harrow, and Five Others

Alcon reported Nov. 11 that its Q3-2025 net sales totaled $2.6 billion, a 6 percent increase over $2.4 billion in Q3-2024. Surgical net sales for implantables, consumables, and equipment/other were...

Sydnexis Gains UK Approval for Low-Dose Atropine Drops in Pediatric Myopia
Sydnexis Gains UK Approval for Low-Dose Atropine Drops in Pediatric Myopia

Sydnexis announced Nov. 6 that the UK’s Medicines and Healthcare Products Regulatory Agency had granted marketing authorization for Ryjunea, the company’s low-dose atropine formulation for slowing ...

STAAR Solicits New Bids Under Amended Deal with Alcon, Moves Shareholder Vote to Dec. 19
STAAR Solicits New Bids Under Amended Deal with Alcon, Moves Shareholder Vote to Dec. 19

STAAR Surgical reported Nov. 7 that it had amended its merger agreement with Alcon to allow STAAR to solicit new buyers for 30 days under a new “go-shop” period ending Dec. 6. STAAR also delayed to...

Richard Pazdur, MD, to Lead US FDA’s Center for Drug Evaluation and Research
Richard Pazdur, MD, to Lead US FDA’s Center for Drug Evaluation and Research

The US FDA reported Nov. 11 that oncologist Richard Pazdur, MD, had been named director of the Center for Drug Evaluation and Research (CDER). Pazdur is a 26-year veteran of the FDA and the foundin...

UK High Court Ruling Paves Way for Launch of Alvotech’s Aflibercept Biosimilar
UK High Court Ruling Paves Way for Launch of Alvotech’s Aflibercept Biosimilar

Iceland’s Alvotech announced Nov. 10 that the UK High Court had rejected an injunction from Eylea marketers Regeneron and Bayer against Alvotech and its contract manufacturing organization. The dec...

Kwangdong Submits NDA in South Korea for Tenpoint’s Presbyopia Drop
Kwangdong Submits NDA in South Korea for Tenpoint’s Presbyopia Drop

Tenpoint Therapeutics announced Nov. 5 that Kwangdong Pharmaceutical had submitted a new drug application (NDA) to the Ministry of Food and Drug Safety in South Korea for Brimochol PF, a combinatio...

Mallinckrodt Spins Off Generics Business, Rebrands as Keenova
Mallinckrodt Spins Off Generics Business, Rebrands as Keenova

Drugmaker Mallinckrodt announced Nov. 10 that it had completed the planned spinoff of its Par Health generic pharmaceuticals and sterile injectables businesses and had rebranded as Keenova Therapeu...

PolyActiva, RareSight to Collaborate on Rare Pediatric Retinal Diseases
PolyActiva, RareSight to Collaborate on Rare Pediatric Retinal Diseases

Australia’s PolyActiva announced Nov. 5 that it would collaborate with RareSight, of Menlo Park, California, an ophthalmology-focused life sciences company committed to advancing therapies for rare...

CMS’ Changes to Final 2026 Physician Fee Schedule Include Two Significant Cuts
CMS’ Changes to Final 2026 Physician Fee Schedule Include Two Significant Cuts

The Centers for Medicare and Medicaid Services (CMS) made two significant cuts to parts of the formula used to calculate physicians’ Medicare procedure fees in 2026, despite heavy lobbying by the m...

Viridian Submits BLA to US FDA for Veligrotug in Thyroid Eye Disease
Viridian Submits BLA to US FDA for Veligrotug in Thyroid Eye Disease

Viridian Therapeutics announced Nov. 3 that it had submitted a biologics license application (BLA) to the US FDA for veligrotug, the company’s intravenous treatment candidate for thyroid eye diseas...

4DMT Licenses Retinal Gene Therapy Candidate to Otsuka for Asia-Pacific
4DMT Licenses Retinal Gene Therapy Candidate to Otsuka for Asia-Pacific

4D Molecular Therapeutics announced Oct. 30 a strategic partnership with Otsuka Pharmaceutical Co. to develop and commercialize retinal gene therapy candidate 4D-150 in the greater Asia-Pacific (AP...

Q3-2025 Ophthalmic Revenue Roundup for Amgen, AbbVie, Hoya, Glaukos, Apellis, Astellas, and Four Others
Q3-2025 Ophthalmic Revenue Roundup for Amgen, AbbVie, Hoya, Glaukos, Apellis, Astellas, and Four Others

Amgen, of Thousand Oaks, California, reported Nov. 4 that its Q3-2025 revenue from Tepezza was $560 million, a 15 percent increase over $488 million in Q3-2024. The total consisted of $518 million ...

Samsung Bioepis to Commercialize Byooviz in Europe Starting in January 2026
Samsung Bioepis to Commercialize Byooviz in Europe Starting in January 2026

South Korea’s Samsung Bioepis announced Oct. 29 that it would assume responsibility for the marketing of Byooviz (ranibizumab), a Lucentis biosimilar, in Europe upon the transfer of commercial righ...

UK Accepts Conditional Marketing Application for Belite Bio’s Tinlarebant in Stargardt
UK Accepts Conditional Marketing Application for Belite Bio’s Tinlarebant in Stargardt

Belite Bio announced Nov. 2 that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) had agreed to accept a conditional marketing authorization application for oral tinlarebant for ...

FDA Clears Way for US Patient to Receive GenSight’s Lumevoq for LHON
FDA Clears Way for US Patient to Receive GenSight’s Lumevoq for LHON

France’s GenSight Biologics announced Oct. 30 that the FDA had granted permission for a single patient in the US to be treated with GS010, also known as Lumevoq, GenSight’s intravitreal gene therap...

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

Outlook Therapeutics reported Nov. 3 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-rela...

Visara Licenses Retinal Candidate to Everest for Greater China, Other Asian Countries
Visara Licenses Retinal Candidate to Everest for Greater China, Other Asian Countries

NovaBridge Biosciences announced Oct. 29 that its ophthalmic subsidiary, Visara, had licensed retinal treatment candidate VIS-101 to Everest Medicines for greater China, Singapore, South Korea, and...

Roche Reports Mixed Phase III Data for Vamikibart in Uveitic Macular Edema
Roche Reports Mixed Phase III Data for Vamikibart in Uveitic Macular Edema

Swiss drugmaker Roche reported on Oct. 16 mixed Phase III results for vamikibart, an IL-6 inhibitor being developed to address inflammation in uveitic macular edema (UME). Vamikibart, if approved, ...

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