Latest Industry News & Trends

Market Scope provides comprehensive coverage of the ophthalmic market. Our news stories are a combination of public and proprietary content ranging from coverage of international meetings, surgeon survey results and trends, analysis of company financial reports and public medical registries, press releases, and interviews with executives. Register today to receive free weekly email updates, our top data chart, surgeon poll results, and much more. Locked content can be accessed through a subscription to our ophthalmic industry newsletters.

Europe News

12/6/2024
BreakingEuropeIOLPresbyopiaRefractiveSurgical
Ophtec Receives CE Marking for Artiplus Phakic IOL, Targets Young Presbyopes
Ophtec Receives CE Marking for Artiplus Phakic IOL, Targets Young Presbyopes

Dutch company Ophtec announced Nov. 18 that it had gained CE Mark approval for its Artiplus phakic intraocular lens (IOL). The company said the lens offered a solution for relatively young presbyop...

12/6/2024
BreakingEuropeGene TherapyRegulationRetina
EU Grants Orphan Drug Status to Ocugen’s Gene Therapy Candidate for ABCA4-Associated Retinopathies
EU Grants Orphan Drug Status to Ocugen’s Gene Therapy Candidate for ABCA4-Associated Retinopathies

Ocugen announced Nov. 20 that the European Medicines Agency had granted orphan medicinal product status for OCU410ST, a gene therapy candidate targeting ABCA4-associated retinopathies, including St...

11/27/2024
BreakingEuropeGene TherapyRegulationRetina
GenSight Submits Updated Data on Lumevoq to Restart Early Access Program in France
GenSight Submits Updated Data on Lumevoq to Restart Early Access Program in France

Paris-based GenSight Biologics announced Nov. 13 that it had submitted an updated regulatory file for Lumevoq, its gene therapy candidate for Leber hereditary optic neuropathy (LHON), to French reg...

11/22/2024
BiosimilarsBreakingEuropeRegulationRetina
Samsung Bioepis, Biogen Gain EU Approval for Aflibercept Biosimilar Known as Opuviz
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...

11/15/2024
BiosimilarsBreakingEuropeRegulationRetina
Sandoz Gains EU Approval for its Aflibercept Biosimilar Known as Afqlir
Sandoz Gains EU Approval for its Aflibercept Biosimilar Known as Afqlir

Swiss drugmakerSandoz announced Nov. 15 that the European Commission had granted marketing authorization for Afqlir (aflibercept), an Eylea biosimilar. Afqlir, available as a 2 mg vial kit and pre-...

11/8/2024
BreakingCataractEuropeGlaucomaIndiaIndustryMeetingNewsletterRefractiveRetina
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.

11/8/2024
BreakingCataractDealsEuropePharma
DÁVI Licenses Clobetasol Propionate Post-op Drops from Formosa for Portugal
DÁVI Licenses Clobetasol Propionate Post-op Drops from Formosa for Portugal

Taiwan-based Formosa Pharmaceuticals announced Oct. 31 that it had entered into an exclusive licensing agreement with DÁVI Farmacêutica, of Portugal, for the rights there to market clobetasol propi...

11/1/2024
BreakingEuropePharmaRegulationRetina
Astellas Withdraws EU Marketing Application for Avacincaptad Pegol in GA
Astellas Withdraws EU Marketing Application for Avacincaptad Pegol in GA

Japan’s Astellas Pharma announced Oct. 28 that it had withdrawn its marketing authorization application in the EU for avacincaptad pegol, a complement-5 inhibitor targeting geographic atrophy (GA) ...

10/15/2024
ESCRSEuropeMeetingNewsletter
ESCRS Congress Boasts Record Attendance in Barcelona
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...

10/15/2024
EuropeMeetingNewsletterRetina
EU Regulators Rain on Apellis’ Party at 2024 Euretina Congress
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...

10/15/2024
EuropeGlaucomaNewsletterPharmaRegulation
AbbVie Withdraws EU Marketing Application for Durysta Implant for Glaucoma
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...

10/15/2024
Clinical TrialEuropeMeetingNewsletterRetina
Retina Specialists Grapple with Functional Endpoints in Clinical Trials
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)...

10/15/2024
EuropeMeetingNewsletterRetinaSurgical
Retina Surgeons at European Meetings Ask, ‘What’s New?’
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...

10/15/2024
ESCRSEuropeMeetingNewsletterRegulation
ESCRS iNovation Day Looks at MDR Roadblocks, Global Care Issues
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...

10/15/2024
ESCRSEuropeMeetingNewsletterPresbyopia
ISOP Meeting Examines Importance of Patient Education and Predictable Outcomes
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 ...

10/15/2024
ESCRSEnvironmentEuropeMeetingNewsletter
Sustainability: Walking the Walk or Talking the Talk?
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...

10/15/2024
DealsESCRSEuropeFundingMeetingNewsletter
Investors Take Temperature of Ophthalmic Market at European Futures Forum
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...

10/15/2024
ESCRSEuropeHyperopiaMeetingNewsletterRefractiveSurgical
Hyperopia Treatment Using Lenticule Extraction Showcased to Eager European Ophthalmologists
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 ...

10/15/2024
CornealESCRSEuropeMeetingNewsletter
Cornea Surgeons Examine New Crosslinking Options and Old Debates
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...

10/15/2024
ESCRSEuropeIOLMeetingNewsletter
ESCRS Congress Celebrates 75th Anniversary of First IOL Implantation
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...

10/15/2024
ESCRSEuropeIOLMeetingNewsletter
2024 ESCRS Congress Puts Spotlight on Latest IOL Designs
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...

10/15/2024
Clinical TrialESCRSEuropeGlaucomaLaserMeetingNewsletter
ViaLase Releases Latest Glaucoma Laser Data at ESCRS Congress
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...

10/15/2024
ESCRSEuropeMeetingNewsletterRefractiveSurgical
Bausch + Lomb Launches Octavius Topo-Guided Treatment at ESCRS Congress
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...

10/15/2024
BiosimilarsEuropeNewsletterRegulationRetina
Europe’s CHMP Recommends Two Aflibercept Biosimilars for Approval
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 ...

10/15/2024
ChinaClinical TrialDealsDiagnosticDry EyeEuropeGene TherapyGlaucomaIndiaIndustryLaserNewsletterPerimetryRegulationRetinaSurgical
October 2024 Ophthalmic News Briefs
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...

10/4/2024
BreakingDealsDry EyeEuropeRegulation
EU Regulators Approve Vevizye from Novaliq; Théa Will Commercialize Dry Eye Drop
EU Regulators Approve Vevizye from Novaliq; Théa Will Commercialize Dry Eye Drop

Germany’s Novaliq announced Oct. 2 that the European Commission had approved its dry eye treatment Vevizye (cyclosporine ophthalmic solution) 0.1%. The product is indicated for the treatment of mod...

10/4/2024
BreakingCornealEurope
SIFI Launches Akantior Drops for Acanthamoeba Keratitis in Germany
SIFI Launches Akantior Drops for Acanthamoeba Keratitis in Germany

Italy’s SIFI announced Sept. 30 the launch in Germany of its Akantior (polihexanide 0.08%) drops for the treatment of Acanthamoeba keratitis (AK), a parasitic infection of the eye, in patients 12 a...

9/27/2024
BreakingEuropeGlaucomaPharmaRegulation
AbbVie Withdraws EU Marketing Application for Durysta
AbbVie Withdraws EU Marketing Application for Durysta

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...

9/27/2024
BiosimilarsBreakingEuropeRetina
Europe’s CHMP Recommends Two Aflibercept Biosimilars for Approval
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 ...

9/20/2024
BreakingEuropeRegulationRetina
Apellis Receives Negative CHMP Opinion on Pegcetacoplan in GA After Re-examination
Apellis Receives Negative CHMP Opinion on Pegcetacoplan in GA After Re-examination

Apellis Pharmaceuticals announced Sept. 20 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had reaffirmed its June 2024 negative opinion on the company’s ...

9/19/2024
EuropeNewsletterRegulation
EC Approves SIFI’s Akantior Drops for Acanthamoeba Keratitis
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...

9/6/2024
BreakingEuropeRefractiveSurgical
Carl Zeiss Meditec Introduces Hyperopia Treatment Using Lenticule Extraction
Carl Zeiss Meditec Introduces Hyperopia Treatment Using Lenticule Extraction

German company Carl Zeiss Meditec reported Aug. 24 that it had become the first medical device manufacturer to introduce in the CE market the treatment of hyperopia using lenticule extraction. This...

8/30/2024
BreakingCataractESCRSEuropeIOLSurgical
Rayner to Roll Out First Spiral IOL at 2024 ESCRS Congress
Rayner to Roll Out First Spiral IOL at 2024 ESCRS Congress

UK-based Rayner reported Aug. 26 that it was set to launch the first spiral intraocular lens models—the RayOne Galaxy and Galaxy Toric—at the 2024 ESCRS Congress, set for Sept. 6-10 in Barcelona, S...

8/30/2024
BreakingCornealEuropePharmaRegulation
European Commission Approves SIFI’s Akantior Drops for Acanthamoeba Keratitis
European Commission 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...

8/30/2024
AIBreakingDealsDiagnosticEuropeGlaucomaRetina
Revenio’s iCare Subsidiary Acquires AI Screening Company Thirona Retina
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...

8/23/2024
BreakingEuropeRegulationRetina
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...

8/21/2024
EuropeNewsletterRegulationRevenue
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...

8/21/2024
EuropeGlaucomaLaserNewsletterRegulationSurgical
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...

8/21/2024
CataractEuropeMeetingNewsletterRefractiveSurgical
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...

8/21/2024
BiosimilarsCornealDealsDry EyeEuropeGene TherapyGenericsIndustryLow VisionNewsletterOcular CancerPharmaPresbyopiaRegulationRetina
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...

8/2/2024
BreakingEuropeGlaucomaLaserRegulationSurgical
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...

8/2/2024
BreakingEuropeRegulationRetina
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...

8/2/2024
BiosimilarsBreakingDry EyeEuropeRegulationRetina
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...

7/26/2024
BreakingCornealEuropeRegulation
Advisory Panel Recommends Orphan Drug Status for SIFI’s Polihexanide in Fungal Keratitis
Advisory Panel Recommends Orphan Drug Status for SIFI’s Polihexanide in Fungal Keratitis

Italy’s SIFI announced July 22 that a European advisory panel had recommended orphan drug designation for its polihexanide eye drop for fungal keratitis. The Committee for Orphan Medicinal Products...

7/23/2024
EuropeNewsletterRegulationRetina
US FDA Approves Vabysmo Prefilled Syringe for Wet AMD, DME, and RVO Indications
US FDA Approves Vabysmo Prefilled Syringe for Wet AMD, DME, and RVO Indications

Genentech, a member of the Roche Group, announced July 5 that the US FDA had approved the Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe for wet age-related macular degeneration (AMD...

7/23/2024
BiosimilarsClinical TrialCornealDealsDry EyeEuropeGene TherapyGlaucomaIndiaIndustryMyopiaNewsletterRegulationRetina
July 2024 Ophthalmic News Briefs
July 2024 Ophthalmic News Briefs

Bausch + Lomb announced July 23 that it had acquired dry eye diagnostic company Trukera Medical from its private equity owner, AccelMed Partners, and other shareholders. No financial details were d...

7/11/2024
BreakingEuropeRegulationRetina
UK Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD
UK Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD

Outlook Therapeutics announced July 8 that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) had granted marketing authorization for Lytenava, an ophthalmic formulation of bevaciz...

7/11/2024
BreakingCataractDealsEuropeRefractiveSurgical
Ophthalmology Chain Clínica Baviera Enters UK Market with Acquisition of Optimax
Ophthalmology Chain Clínica Baviera Enters UK Market with Acquisition of Optimax

European ophthalmology chain Clínica Baviera has extended its reach into the UK with the purchase of Optimax. Optimax (Eye Hospitals Group and subsidiaries) operates 19 clinics under the Optimax an...

7/11/2024
BiosimilarsBreakingEuropeRegulationRetina
Altos Biologics Files for European Approval of Aflibercept (Eylea) Biosimilar
Altos Biologics Files for European Approval of Aflibercept (Eylea) Biosimilar

Altos Biologics has submitted a marketing authorization application to the European Medicines Agency (EMA) for ALT-L9, an aflibercept (Eylea) biosimilar, according to a joint announcement by Altos ...

7/5/2024
BreakingEuropeRegulationRetina
Roche’s Vabysmo Gains Positive CHMP Opinion in EU for Third Indication—RVO
Roche’s Vabysmo Gains Positive CHMP Opinion in EU for Third Indication—RVO

Swiss drugmaker Roche announced June 28 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended the extension of Vabysmo’s labeling to include tre...

6/24/2024
EuropeNewsletterRegulationRetina
EU Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD
EU Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD

Outlook Therapeutics announced May 28 that the European Commission had granted marketing authorization for Lytenava, an ophthalmic formulation of bevacizumab for the treatment of wet age-related ma...

6/24/2024
CornealEuropeNewsletterRegulation
SIFI’s Acanthamoeba Keratitis Eye Drop Candidate Gains Positive CHMP Opinion
SIFI’s Acanthamoeba Keratitis Eye Drop Candidate Gains Positive CHMP Opinion

Italy’s SIFI announced May 31 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of Akantior (polihexanide 0.08%) for the treatment...

6/14/2024
BreakingCataractEuropeIOLRegulationSurgical
Nidek Gains CE Marking for Preloaded IOL Injector System
Nidek Gains CE Marking for Preloaded IOL Injector System

Japan’s Nidek announced June 10 that it had received CE marking for the NP-1/NP-1C preloaded IOL injection system. The system is preloaded with the Aktis aspheric hydrophobic soft acrylic lens, whi...

6/7/2024
BreakingCornealEuropeRegulation
Acanthamoeba Keratitis Eye Drop Candidate from SIFI Gains Positive CHMP Opinion
Acanthamoeba Keratitis Eye Drop Candidate from SIFI Gains Positive CHMP Opinion

Italy’s SIFI announced May 31 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of Akantior (polihexanide 0.08%) for the treatment...

5/31/2024
BreakingEuropePharmaRegulationRetina
EU Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD
EU Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD

Outlook Therapeutics announced May 28 that the European Commission had granted marketing authorization for Lytenava, an ophthalmic formulation of bevacizumab for the treatment of wet age-related ma...

5/31/2024
BreakingClinical TrialEuropeMyopia
Dopavision Sees Positive Results in Trial of Photobiomodulation for Myopia
Dopavision Sees Positive Results in Trial of Photobiomodulation for Myopia

Germany’s Dopavision reported May 28 that its MyopiaX photobiomodulation system targeting myopia showed signals of clinical effect on the rate of progression at six months in a proof-of-concept tri...

5/31/2024
BreakingEuropeMyopiaRegulation
EU Accepts Vyluma’s Marketing Application for Low-Dose Atropine in Childhood Myopia
EU Accepts Vyluma’s Marketing Application for Low-Dose Atropine in Childhood Myopia

Vyluma reported May 29 that the European Medicines Agency had accepted its marketing application for lead compound NVK002, a low-dose formulation of atropine targeting childhood myopia. NVK002 is a...

5/22/2024
EuropeNewsletterRetina
Euretina President Ramin Tadayoni, MD, PhD, Dies at 54
Euretina President Ramin Tadayoni, MD, PhD, Dies at 54

The European Society of Retina Specialists, or Euretina, reported April 20 that its president, retina specialist Ramin Tadayoni, MD, PhD, had died. He was 54. Tadayoni was attending the Brazilian R...

5/10/2024
BreakingDiagnosticDry EyeEurope
Lumibird Launches C.Diag Diagnostic Platform for Dry Eye
Lumibird Launches C.Diag Diagnostic Platform for Dry Eye

France’s Lumibird Medical announced May 3 that it had launched C.Diag, a dry eye diagnostic imaging platform incorporating artificial intelligence, after gaining the European Union’s CE marking for...

4/26/2024
BreakingEuropeRetina
Euretina President Ramin Tadayoni, MD, PhD, Dies at 54
Euretina President Ramin Tadayoni, MD, PhD, Dies at 54

The European Society of Retina Specialists, or Euretina, reported April 20 that its president, retina specialist Ramin Tadayoni, MD, PhD, had died. He was 54. Tadayoni was attending the Brazilian R...

4/24/2024
EuropeNewsletterRegulationRetina
Ophthalmic Bevacizumab Candidate from Outlook Gains Positive CHMP Opinion
Ophthalmic Bevacizumab Candidate from Outlook Gains Positive CHMP Opinion

Outlook Therapeutics announced March 22 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of ONS-5010 (L...

4/12/2024
BreakingEmergingEuropeFundingGlaucomaSurgical
LEP Raises Funding to Advance Glaucoma Implant Targeting Inflammation, Fibrosis
LEP Raises Funding to Advance Glaucoma Implant Targeting Inflammation, Fibrosis

Ireland-based LEP Biomedical reported April 4 that it had closed a pre-seed funding round of €100 thousand to advance its HyaGuard platform. HyaGuard is a biodegradable, subconjunctival insert desi...

3/22/2024
BreakingEuropeRegulationRetina
Ophthalmic Bevacizumab Candidate from Outlook Gains Positive CHMP Opinion
Ophthalmic Bevacizumab Candidate from Outlook Gains Positive CHMP Opinion

Outlook Therapeutics announced March 22 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of ONS-5010 (L...

2/23/2024
BreakingCataractEuropeIOLMeetingSurgical
VSY Launches Enova Maestro Trifocal Toric Preloaded IOL at ESCRS Winter Meeting
VSY Launches Enova Maestro Trifocal Toric Preloaded IOL at ESCRS Winter Meeting

Germany’s VSY Biotechnology launched its Enova Maestro trifocal toric preloaded intraocular lens (IOL) at the European Society of Cataract and Refractive Surgeons (ESCRS) Winter Meeting, held Feb. ...

2/23/2024
BreakingEuropeGlaucomaMeetingSurgical
Sight Sciences Reports Launching of Omni Ergo-Series for Canaloplasty in Europe at ESCRS Winter Meeting
Sight Sciences Reports Launching of Omni Ergo-Series for Canaloplasty in Europe at ESCRS Winter Meeting

Sight Sciences announced Feb. 14 that it would launch the Ergo-Series of its Omni system for canaloplasty in Europe at the European Society of Cataract and Refractive Surgeons (ESCRS) Winter Meetin...

2/22/2024
EuropeNewsletterRegulationRetina
Apellis Seeks Re-examination of EU Marketing Application for Pegcetacoplan in GA
Apellis Seeks Re-examination of EU Marketing Application for Pegcetacoplan in GA

Apellis Pharmaceuticals announced Jan. 26 that, as expected, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recom-mended refusal of the company’s marketin...

2/22/2024
CataractEuropeIOLNewsletterSurgical
Johnson & Johnson MedTech Launches Tecnis PureSee PC-IOL in EMEA Countries
Johnson & Johnson MedTech Launches Tecnis PureSee PC-IOL in EMEA Countries

Johnson & Johnson MedTech announced Feb. 15 that its Tecnis PureSee refractive presbyopia-correcting intraocular lens (IOL) is now available in select markets in Europe, the Middle East, and Africa...

2/22/2024
CataractEuropeIOLNewsletterSurgical
February 2024 Weekly Surgeon Poll: US vs. Western European Ophthalmologists
February 2024 Weekly Surgeon Poll: US vs. Western European Ophthalmologists

2/16/2024
BreakingCataractEuropeIOLSurgical
Johnson & Johnson MedTech Launches Tecnis PureSee PC-IOL in Select EMEA Countries
Johnson & Johnson MedTech Launches Tecnis PureSee PC-IOL in Select EMEA Countries

Johnson & Johnson MedTech announced Feb. 15 that its Tecnis PureSee refractive presbyopia-correcting intraocular lens (IOL) is now available in select markets in Europe, the Middle East, and Africa...

2/9/2024
BreakingDiagnosticEuropeRegulation
Toku Gains EU, UK Approval for AI Cardiovascular Risk Assessments Through the Eye
Toku Gains EU, UK Approval for AI Cardiovascular Risk Assessments Through the Eye

Toku, of San Diego, California, announced Feb. 5 that it had obtained CE and UK Conformity Assessment (UKCA) marking for its patented CLAiR technology—AI-powered software that identifies elevated c...

2/9/2024
BreakingCataractEuropeSurgical
Keranova Appoints Denise Hoblingre as CEO
Keranova Appoints Denise Hoblingre as CEO

France’s Keranova recently announced that Denise Hoblingre had been appointed chief executive officer. She succeeds company co-founder Fabrice Romano, DVM. Hoblingre joined Keranova at its inceptio...

2/2/2024
BreakingEuropePharmaRegulationRetina
Apellis Seeks Re-examination of EU Marketing Application for Pegcetacoplan in GA after Negative CHMP Opinion
Apellis Seeks Re-examination of EU Marketing Application for Pegcetacoplan in GA after Negative CHMP Opinion

Apellis Pharmaceuticals announced Jan. 26 that, as expected, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended refusal of the company’s marketing...

1/12/2024
BreakingEuropePharmaRegulationRetina
Bayer Receives EU Approval for High-Dose Eylea
Bayer Receives EU Approval for High-Dose Eylea

German drugmaker Bayer announced Jan. 8 that the European Commission had granted marketing authorization in the EU for high-dose Eylea (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the...

12/20/2023
BreakingCataractEuropeIOLSurgical
Ophtec Launches Precizon Go Enhanced Monofocal IOL
Ophtec Launches Precizon Go Enhanced Monofocal IOL

Dutch company Ophtec announced Dec. 11 the launch of its Precizon Go intraocular lens (IOL), a “monofocal plus” lens designed to provide distance and enhanced intermediate vision. Precizon Go featu...

12/20/2023
BreakingEuropeRegulationRetina
Apellis Says it Expects Negative CHMP Opinion on Pegcetacoplan for GA, Plans Appeal
Apellis Says it Expects Negative CHMP Opinion on Pegcetacoplan for GA, Plans Appeal

Apellis Pharmaceuticals announced Dec. 14 that Europe’s Committee for Medicinal Products for Human Use (CHMP) was trending toward issuing a negative opinion on the company’s marketing application f...

11/22/2023
BreakingEuropeGlaucomaPharmaRegulation
Santen Receives EU Approval for Catiolanze (Preservative-Free Latanoprost) in Glaucoma
Santen Receives EU Approval for Catiolanze (Preservative-Free Latanoprost) in Glaucoma

Japanese drugmaker Santen Pharmaceutical announced Nov. 17 that the European Commission had approved its marketing authorization application for preservative-free Catiolanze (cationic emulsion of l...

11/21/2023
EuropeMeetingNewsletterRetina
Euretina Prepares European Doctors for the GA Revolution
Euretina Prepares European Doctors for the GA Revolution

The 2023 Euretina congress presented an array of information and technologies that could make European retina specialists better prepared for the arrival of treatments for geographic atrophy than w...

11/21/2023
EuropeMeetingNewsletterRetina
Europe Still in Grips of Visudyne Shortage
Europe Still in Grips of Visudyne Shortage

The Visudyne shortage is into its third year in Europe after emerging in May 2020 due a reduction in manufacturing capacity, according to the European Medicines Agency. The shortage made the questi...

10/27/2023
BreakingEuropePharmaRegulationRetina
EMA Grants PRIME Designation to 4DMT’s 4D-150 Gene Therapy Candidate in Wet AMD
EMA Grants PRIME Designation to 4DMT’s 4D-150 Gene Therapy Candidate in Wet AMD

4D Molecular Therapeutics announced Oct. 23 that the European Medicines Agency had granted Priority Medicine (PRIME) designation for 4DMT’s intravitreal gene therapy candidate 4D-150 in wet age-rel...

10/27/2023
BreakingEuropePharmaRegulationRetina
EMA Grants PRIME Designation to Annexon’s ANX007 IVT Candidate for GA
EMA Grants PRIME Designation to Annexon’s ANX007 IVT Candidate for GA

Annexon announced Oct. 24 that the European Medicines Agency had granted Priority Medicine (PRIME) designation to ANX007 for the treatment of geographic atrophy (GA) secondary to age-related macula...

10/24/2023
BiosimilarsEuropeNewsletterRegulationRetina
Biocon Receives EU Marketing Approval for Yesafili, an Aflibercept Biosimilar
Biocon Receives EU Marketing Approval for Yesafili, an Aflibercept Biosimilar

India’s Biocon Biologics announced Sept. 20 that the European Commission had granted marketing authorization in the European Union for Yesafili, an aflibercept (Eylea) biosimilar. Yesafili is appro...

9/29/2023
BiosimilarsBreakingEuropeRegulationRetina
Biocon Receives EU Marketing Approval for Yesafili, an Aflibercept Biosimilar
Biocon Receives EU Marketing Approval for Yesafili, an Aflibercept Biosimilar

India’s Biocon Biologics announced Sept. 20 that the European Commission had granted marketing authorization in the European Union for Yesafili, an aflibercept (Eylea) biosimilar. Yesafili is appro...

9/29/2023
BreakingChinaDealsDry EyeEurope
CS Pharmaceuticals acquires AxeroVision and Cream-Based Dry Eye Candidate
CS Pharmaceuticals acquires AxeroVision and Cream-Based Dry Eye Candidate

London-based CS Pharmaceuticals reported July 28 that it had acquired AxeroVision, of Carlsbad, California, and its AXR-270 candidate for dry eye disease. The company did not report financial detai...

9/21/2023
AcquisitionsDealsEuropeNewsletterSurgical
BVI Expands Presence in Spain and Portugal with Acquisition of Medical Mix
BVI Expands Presence in Spain and Portugal with Acquisition  of Medical Mix

BVI Medical announced Sept. 6 that it had acquired Medical Mix, a leading supplier of ophthalmic surgical devices in Spain and Portugal. No financial details were provided. Medical Mix, of Barcelon...

9/21/2023
ChinaClinical TrialCornealDealsDiagnosticDry EyeEuropeGene TherapyIndustryNewsletterRefractiveRegulationRetinaSurgical
September 2023 Ophthalmic News Briefs
September 2023 Ophthalmic News Briefs

Carl Zeiss Meditec announced Aug. 23 that more than 8 million eyes had been treated with the company’s SMILE procedure through the first half of 2023. SMILE, short for small-incision lenticule extr...

9/8/2023
AcquisitionsBreakingDealsEuropeSurgical
BVI Expands Presence in Spain and Portugal with Acquisition of Medical Mix
BVI Expands Presence in Spain and Portugal with Acquisition of Medical Mix

BVI Medical announced Sept. 6 that it had acquired Medical Mix, a leading supplier of ophthalmic surgical devices in Spain and Portugal. No financial details were provided. Medical Mix, of Barcelon...

8/25/2023
BreakingDry EyeEuropeRegulation
EMA Accepts Marketing Application for Dry Eye Candidate CyclASol from Novaliq
EMA Accepts Marketing Application for Dry Eye Candidate CyclASol from Novaliq

Novaliq, of Heidelberg, Germany, announced Aug. 24 that the European Medicines Agency (EMA) had accepted its marketing authorization application for dry eye candidate CyclASol (cyclosporine ophthal...

8/25/2023
BreakingClinical TrialEuropeGene TherapyRegulationRetina
EMA Gives Green Light to Phase Ib Trial of ViGeneron’s Gene Therapy Candidate for RP
EMA Gives Green Light to Phase Ib Trial of ViGeneron’s Gene Therapy Candidate for RP

Germany’s ViGeneron announced Aug. 22 that the European Medicines Agency (EMA) had approved its clinical trial application for VG901, a gene therapy candidate targeting CNGA1-associated retinitis p...

8/18/2023
BreakingEuropePharmaRegulationRetina
EMA Accepts Marketing Application for Geographic Atrophy Candidate from Iveric Bio
EMA Accepts Marketing Application for Geographic Atrophy Candidate from Iveric Bio

Iveric Bio, an Astellas company, announced Aug. 18 that the European Medicines Agency (EMA) had accepted for review its marketing authorization application for avacincaptad pegol, a complement C5 i...

7/28/2023
BiosimilarsBreakingEuropeRegulationRetina
Aflibercept Biosimilar Candidate from Biocon Gains Positive CHMP Opinion
Aflibercept Biosimilar Candidate from Biocon Gains Positive CHMP Opinion

India’s Biocon Biologics announced July 24 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of Yesafili...

7/25/2023
EuropeGlaucomaMeetingNewsletterSurgical
European Glaucoma Society Expected to Issue New MIGS Guidelines
European Glaucoma Society Expected to Issue New MIGS Guidelines

Fotis Topouzis, MD, PhD (Greece), gave the World Glaucoma Congress a preview of the European Glaucoma Society’s new guidelines for minimally invasive glaucoma surgery (MIGS). The term “MIGS” in Eur...

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