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Visiox to Merge with Ocuvex to Advance Candidates for Glaucoma, Postsurgical Pain and Inflammation
Visiox to Merge with Ocuvex to Advance Candidates for Glaucoma, Postsurgical Pain and Inflammation

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 ...

EMA Accepts Marketing Application for Aflibercept (Eylea) Biosimilar from Alvotech
EMA Accepts Marketing Application for Aflibercept (Eylea) Biosimilar from Alvotech

Biosimilar company Alvotech and its partner Advanz Pharma announced Aug. 15 that the European Medicines Agency (EMA) had accepted a marketing authorization application for AVT06, Alvotech’s propose...

Acelyrin Shifts Pipeline to Focus on TED Candidate, Lays Off About 40 Workers
Acelyrin Shifts Pipeline to Focus on TED Candidate, Lays Off About 40 Workers

Acelyrin reported Aug. 13 that it would reduce its workforce and shift its pipeline strategy to prioritize lonigutamab, its candidate for thyroid eye disease (TED). The announcement came amid posit...

European Five Market Expected to Grow, Despite MDR Delays
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...

US FDA Grants Tentative Approval to Generic Brimonidine Tartrate Ophthalmic Solution (Lumify) from Lupin
US FDA Grants Tentative Approval to Generic Brimonidine Tartrate Ophthalmic Solution (Lumify) from Lupin

Indian drugmaker Lupin announced Aug. 14 that it had received tentative approval from the US FDA for its abbreviated new drug application for brimonidine tartrate ophthalmic solution 0.025%, a gene...

US FDA Grants Rare Pediatric Disease Designation to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate
US FDA Grants Rare Pediatric Disease Designation to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate

Atsena Therapeutics announced Aug. 14 that ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS), had received the US FDA’s rare pediatric disease designation. XLRS is a monogenic ...

US FDA Grants Rare Pediatric Disease Designation to Opus’ LCA5 Gene Therapy Candidate
US FDA Grants Rare Pediatric Disease Designation to Opus’ LCA5 Gene Therapy Candidate

Opus Genetics announced Aug. 20 that OPGx-LCA5, its gene therapy candidate for Leber congenital amaurosis (LCA) resulting from biallelic mutations in the LCA5 gene, had received the US FDA’s rare p...

Eyenovia Plans to Seek US FDA Clearance for Gen-2 Optejet Microdoser
Eyenovia Plans to Seek US FDA Clearance for Gen-2 Optejet Microdoser

Eyenovia announced in its Q2-2024 financial results that it planned to seek marketing clearance for an advanced Gen-2 Optejet microdoser. Eyenovia, of New York, said production was expected to begi...

SalioGen Therapeutics Appoints Kali Stasi, MD, PhD, as Chief Medical Officer
SalioGen Therapeutics Appoints Kali Stasi, MD, PhD, as Chief Medical Officer

SalioGen Therapeutics announced Aug. 19 that it had appointed Kalliopi “Kali” Stasi, MD, PhD, as chief medical officer. SalioGen said Stasi will be responsible for bringing the company’s SGT-1001, ...

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

Physician With Blepharospasm Fights MACs’ Proposed Limits on Botulinum Toxin Injections
Physician With Blepharospasm Fights MACs’ Proposed Limits on Botulinum Toxin Injections

Patients with blepharospasm, a rare ophthalmic disease, are facing a proposal by five of the seven Medicare administrative contractors (MACs) to limit the botulinum toxin injections that control th...

2024-2025 Ophthalmic Meetings Calendar
2024-2025 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.

Clinical Trial Updates for Ophthalmic Candidates, August 2024
Clinical Trial Updates for Ophthalmic Candidates, August 2024

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

Emerging Companies Pursuing Ophthalmic Indications, August 2024
Emerging Companies Pursuing Ophthalmic Indications, August 2024

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

USC Alums Gift Eye Care Practice to Roski Eye Institute
USC Alums Gift Eye Care Practice to Roski Eye Institute

Richard Weise, MD, and his wife, Cathy, have gifted their ophthalmic practice, the Glendale Eye Medical Group, of Glendale, California, to the USC Roski Eye Institute, the university announced July...

Weekly Surgeon Poll, August 2024
Weekly Surgeon Poll, August 2024

Renowned Charity HCP Cureblindness Rebrands as Cure Blindness Project
Renowned Charity HCP Cureblindness Rebrands as Cure Blindness Project

HCP Cureblindness has rebranded as the Cure Blindness Project, the group announced July 29. The move is designed to better reflect the eye charity’s expanded geographical footprint and commitment t...

August 2024 Ophthalmic News Briefs
August 2024 Ophthalmic News Briefs

Ireland-based Mallinckrodt announced Aug. 6 that its H.P. Acthar Gel single-dose prefilled SelfJect injector was available in the US. The US FDA approved the supplemental new drug application for t...

Ocumension Acquires Rights to Alcon Eye Drops in Exchange for 16.7 Percent Equity Stake
Ocumension Acquires Rights to Alcon Eye Drops in Exchange for 16.7 Percent 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 ...

Q2-2024 Ophthalmic Revenue Roundup for AbbVie, Carl Zeiss Meditec, Amgen, STAAR, Astellas, Immunocore, Tarsus, Biogen, Lensar, and Iridex
Q2-2024 Ophthalmic Revenue Roundup for AbbVie, Carl Zeiss Meditec, Amgen, STAAR, Astellas, Immunocore, Tarsus, Biogen, Lensar, and Iridex

AbbVie, of North Chicago, Illinois, reported July 25 that Q2-2024 net revenue for its eye care products totaled $533 million, a 13.3 percent decline (-10.9 percent cc) from $617 million in Q2-2023....

US FDA Approves Aflibercept (Eylea) Biosimilar from Sandoz
US FDA Approves Aflibercept (Eylea) Biosimilar from Sandoz

Swiss drugmaker Sandoz announced Aug. 12 that the US FDA had approved Enzeevu, an aflibercept (Eylea) biosimilar, for wet age-related macular degeneration (AMD). Enzeevu (aflibercept-abzv) will be ...

Lenz Submits NDA to US FDA for LNZ100 Presbyopia Drop Candidate
Lenz Submits NDA to US FDA for LNZ100 Presbyopia Drop Candidate

Lenz Therapeutics announced Aug. 12 that it had submitted a new drug application to the US FDA for LNZ100, a once-daily, preservative-free eye drop candidate for presbyopia. Lenz, of San Diego, Cal...

US FDA Approves Generic Prednisolone Acetate Drops from India’s Lupin for Ocular Inflammation
US FDA Approves Generic Prednisolone Acetate Drops from India’s Lupin for Ocular Inflammation

Indian drugmaker Lupin announced Aug. 5 that the US FDA had approved its abbreviated new drug application for prednisolone acetate ophthalmic suspension, 1%, a generic equivalent of AbbVie’s Pred F...

LumiThera Gains CPT Code to Report Retinal PBM Therapy, a Step Toward Reimbursement
LumiThera Gains CPT Code to Report Retinal PBM Therapy, a Step Toward Reimbursement

LumiThera announced Aug. 7 that a new Category III CPT code had been established, effective Jan. 1, 2025, to report “Photobiomodulation therapy of retina, single session.” The company said the code...

Santen Licenses Cloudbreak Topical Pterygium Candidate for Japan, Korea, and Southeast Asia
Santen Licenses Cloudbreak Topical Pterygium Candidate for Japan, Korea, and Southeast Asia

Japan’s Santen announced Aug. 6 that it had signed an agreement to license CBT-001, a topical pterygiumtreatment candidate from Cloudbreak Pharma. The deal covers the territories of Japan, South Ko...

US FDA Approves Expanded Access Program for Ocugen’s RP Candidate
US FDA Approves Expanded Access Program for Ocugen’s RP Candidate

Ocugen announced Aug. 5 that the US FDA had approved an expanded access program to allow for the treatment of adults with retinitis pigmentosa (RP) with OCU400—a modifier gene therapy product candi...

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

Q2-2024 Ophthalmic Revenue Roundup for Hoya, Harrow, RxSight, Sight Sciences, Ocular Therapeutix, and EyePoint
Q2-2024 Ophthalmic Revenue Roundup for Hoya, Harrow, RxSight, Sight Sciences, Ocular Therapeutix, and EyePoint

Japan-based Hoya Corporation announced Aug. 1 that its medical care segment (IOLs, endoscopes, artificial bone) had revenue for the quarter ending June 30, 2024—the first quarter of its fiscal year...

USC Alums Gift Eye Care Practice to Roski Eye Institute
USC Alums Gift Eye Care Practice to Roski Eye Institute

Richard Weise, MD, and his wife, Cathy, have gifted their ophthalmic practice, the Glendale Eye Medical Group, of Glendale, California, to the USC Roski Eye Institute, the university announced July...

Physician With Blepharospasm Fights MACs’ Proposed Limits on Botulinum Toxin Injections
Physician With Blepharospasm Fights MACs’ Proposed Limits on Botulinum Toxin Injections

Patients with blepharospasm, a rare ophthalmic disease, are facing a proposal by five of the seven Medicare administrative contractors to limit the botulinum toxin injections that control their sym...

Mallinckrodt Announces Availability of Acthar Gel SelfJect Injector in the US
Mallinckrodt Announces Availability of Acthar Gel SelfJect Injector in the US

Ireland-based Mallinckrodt announced Aug. 6 that its H.P. Acthar Gel single-dose prefilled SelfJect injector was available in the US. The US FDA approved the supplemental new drug application (sNDA...

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

Formosa Licenses Clobetasol Propionate Drops to Apotex for Canada
Formosa Licenses Clobetasol Propionate Drops to Apotex for Canada

Taiwan-based Formosa Pharmaceuticals announced Aug. 5 that it had agreed to license to Apotex exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical inflammation and pain...

Eyedaptic Unveils Eye6 with Ivy AI-Assisted Visual Aid
Eyedaptic Unveils Eye6 with Ivy AI-Assisted Visual Aid

Eyedaptic, of Laguna Hills, California, reported Aug. 5 that it had unveiled its Eye6 with Ivy next-generation wearable vision aid for those with age-related macular degeneration or other retinal d...

HCP Cureblindness Rebrands as Cure Blindness Project
HCP Cureblindness Rebrands as Cure Blindness Project

HCP Cureblindness has rebranded as the Cure Blindness Project, the group announced July 29. The move is designed to better reflect the eye charity’s expanded geographical footprint and commitment t...

ViaLase Gains CE Marking for Femtosecond Laser for Glaucoma Treatment
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...

Q2-2024 Ophthalmic Revenue Roundup for Regeneron, Roche, Bausch + Lomb, Novartis, and Four Others
Q2-2024 Ophthalmic Revenue Roundup for Regeneron, Roche, Bausch + Lomb, Novartis, and Four Others

Regeneron, of Tarrytown, New York, reported Aug. 1 that its Q2-2024 US revenue for Eylea was $1.53 billion, a 2 percent increase from $1.5 billion in Q2-2023. Eylea HD accounted for $304 million of...

Roche’s Vabysmo Gains EU Approval for Third Indication—RVO
Roche’s Vabysmo Gains EU Approval for Third Indication—RVO

Swiss drugmaker Roche announced July 30 that the European Commission had approved Vabysmo for a third indication, the treatment of macular edema due to retinal vein occlusion (RVO). Vabysmo (farici...

Novaliq Receives Positive CHMP Opinion for Vevizye in Dry Eye
Novaliq Receives Positive CHMP Opinion for Vevizye in Dry Eye

Germany’s Novaliq announced July 29 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorization in the European Union for Vevi...

Eyenovia, SGN Nanopharma Will Collaborate on Chronic Dry Eye Candidate with Optejet Microdoser
Eyenovia, SGN Nanopharma Will Collaborate on Chronic Dry Eye Candidate with Optejet Microdoser

Eyenovia, of New York, announced July 30 that it had entered into a collaboration agreement with SGN Nanopharma to develop SGN’s micellar nanoparticle platform-based cyclosporine formulation for us...

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