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Increase in Cases of High Myopia May Affect Retina Subspecialty
Increase in Cases of High Myopia May Affect Retina Subspecialty

Retina specialists may see more myopic patients in the future due to rising cases of myopic choroidal neovascularization (mCNV), according to presentations at the Euretina Congress. The meeting fea...

Euretina Shifts Focus to Overtreatment of Wet AMD Patients
Euretina Shifts Focus to Overtreatment of Wet AMD Patients

Talks about undertreatment of neovascular age-related macular degeneration (wet AMD or nAMD) have become a fixture at retina congresses, with papers demonstrating that better visual outcomes correl...

Euretina Delegates Search for Perfect Balance of Patient Input in Trials
Euretina Delegates Search for Perfect Balance of Patient Input in Trials

Euretina delegates discussed the role of patients in the drug approval process against backdrops consisting of a coming decision by the US FDA on a potential treatment for geographic atrophy (GA) a...

Clinical Trial Updates for Ophthalmic Candidates, September 2022
Clinical Trial Updates for Ophthalmic Candidates, September 2022

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements. Date Company Candidate, Indication Milestone Notes Sept. 13 Pixium Vision Prima subretinal p...

Ophthalmic Diagnostic Equipment Market to Reach $3.3 Billion, Driven by Advances in OCT Technology
Ophthalmic Diagnostic Equipment Market to Reach $3.3 Billion, Driven by Advances in OCT Technology

Retinal diagnostic units continue to drive the ophthalmic diagnostic equipment market in 2022. Eye care professionals employ optical coherence tomography (OCT) devices as a tool to help understand,...

Ophthalmic Laser Market Expected to Total $389.2 Million in 2022
Ophthalmic Laser Market Expected to Total $389.2 Million in 2022

Global revenue for therapeutic ophthalmic lasers—photocoagu-lation, photodisruption (YAG), and SLT—along with maintenance, accessories, and endoprobes, will total over $389.2 million in 2022 and gr...

Tepezza Patient Sues Horizon, Says Extent of Hearing Loss Risk Wasn’t Disclosed
Tepezza Patient Sues Horizon, Says Extent of Hearing Loss Risk Wasn’t Disclosed

A man in Arizona sued Horizon Therapeutics on Aug. 25, alleging that the company failed to inform regulators that its thyroid eye disease medication Tepezza can cause permanent ear ringing and hear...

Emerging Companies Pursuing Ophthalmic Indications, September 2022
Emerging Companies Pursuing Ophthalmic Indications, September 2022

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease. Company Location About Valo Health Boston The company has begun dosing in a Phase II study o...

Weekly Surgeon Poll, September 2022
Weekly Surgeon Poll, September 2022

September 2022 Ophthalmic News Briefs
September 2022 Ophthalmic News Briefs

Teva Pharmaceutical Industries announced Aug. 29 that the European Commission had granted marketing authorization for its Ranivisio (ranibizumab injection), a biosimilar of Lucentis. Ranivisio is a...

Trukera Medical Launches New ScoutPro Osmolarity System
Trukera Medical Launches New ScoutPro Osmolarity System

Trukera Medical, formerly TearLab, on Sept. 12 unveiled the ScoutPro Osmolarity System, the first product under the company’s new brand. The ScoutPro is the first portable osmometer in the US, Truk...

SparingVision Raises $74.9 Million in Series B Financing
SparingVision Raises $74.9 Million in Series B Financing

Private equity firm Jeito Capital announced Sept. 14 that it had co-led a Series B financing round in ophthalmic gene therapy company SparingVision, of France, with proceeds of $74.9 million. Spari...

Celregen Licenses Cellusion’s Corneal Cell Therapy Candidate in Greater China
Celregen Licenses Cellusion’s Corneal Cell Therapy Candidate in Greater China

Cellusion, of Japan, and China’s Celregen announced Sept. 12 an exclusive license agreement in the Greater China region for Celregen to develop, manufacture, and commercialize Cellusion’s CLS001, a...

Himalayan Cataract Project Names Katherine Overbey as CEO
Himalayan Cataract Project Names Katherine Overbey as CEO

The Himalayan Cataract Project (HCP) reported Sept. 8 that it had named Katherine (K-T) Overbey as its new chief executive officer, effective Oct. 4. The renowned and highly acclaimed eye charity, ...

US FDA Waives Fee for Ocuphire’s NDA for Reversal of Mydriasis Candidate Nyxol
US FDA Waives Fee for Ocuphire’s NDA for Reversal of Mydriasis Candidate Nyxol

Ocuphire Pharma announced Sept. 12 that the US FDA had granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of $3.1 million for the company’s new drug application (NDA)...

SIFI Launches Evolux Extended Monofocal IOL
SIFI Launches Evolux Extended Monofocal IOL

Italy’s SIFI announced Sept. 15 the launch of its Evolux extended monofocal intraocular lens (IOL). The lens is made of a hydrophobic material and has a non-diffractive profile, designed to provide...

Santen Appoints Takeshi Ito as President and CEO
Santen Appoints Takeshi Ito as President and CEO

Japan-based Santen Pharmaceutical announced Sept. 12 that it had named Takeshi Ito as its new president and CEO. The move followed the resignation of President and CEO Shigeo Taniuchi for personal ...

LENSAR Applies for Marketing Approval in EU for ALLY Femto-Phaco Platform
LENSAR Applies for Marketing Approval in EU for ALLY Femto-Phaco Platform

LENSAR announced Sept. 8 that it had applied for certification of the ALLY Adaptive Cataract Treatment System in the European Union. The ALLY is a femto-phaco platform designed to allow surgeons to...

High-Dose Aflibercept Meets Endpoints in Pivotal Trials with 12-Week and 16-Week Dosing in DME, Wet AMD
High-Dose Aflibercept Meets Endpoints in Pivotal Trials with 12-Week and 16-Week Dosing in DME, Wet AMD

Regeneron Pharmaceuticals reported on Sept. 8 that the primary endpoints were met in two pivotal trials investigating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic...

First US Patient Receives Autologous Stem Cell Therapy to Treat GA
First US Patient Receives Autologous Stem Cell Therapy to Treat GA

The National Institutes of Health announced Aug. 31 that a surgical team had successfully implanted a patch of tissue made from patient cells with the goal of treating geographic atrophy, the advan...

Glaukos Reports Positive Topline Phase III Data for Travaprost Implant iDose TR
Glaukos Reports Positive Topline Phase III Data for Travaprost Implant iDose TR

Glaukos reported on Sept. 7 positive topline data for both Phase III pivotal trials of its iDose TR sustained-release travaprost implant for glaucoma. Both the fast- and slow-release iDose TR treat...

Ashvattha Enrolls First Patient in Phase II Study of Subcutaneous Candidate in Wet AMD, DME
Ashvattha Enrolls First Patient in Phase II Study of Subcutaneous Candidate in Wet AMD, DME

Ashvattha Therapeutics announced Sept. 7 that the first patient had been enrolled in a Phase II study of D-4517.2, a subcutaneous treatment candidate for wet age-related macular degeneration (AMD) ...

Glaukos Reaches Milestone of 1 Million iStents Implanted
Glaukos Reaches Milestone of 1 Million iStents Implanted

Glaukos, of Aliso Viejo, California, reported Sept. 6 that 1 million iStents had been implanted worldwide. The iStent portfolio now consists of the iStent, iStent Inject, iStent Inject W, and iSten...

Tarsus Submits NDA to US FDA for Demodex Blepharitis Candidate
Tarsus Submits NDA to US FDA for Demodex Blepharitis Candidate

Tarsus Pharmaceuticals announced Sept. 7 that it had submitted a new drug application (NDA) to the US FDA for TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis. ...

US FDA Accepts NDA Filing for Bausch + Lomb, Novaliq Candidate for Dry Eye with MGD
US FDA Accepts NDA Filing for Bausch + Lomb, Novaliq Candidate for Dry Eye with MGD

Bausch + Lomb and Novaliq announced Sept. 6 that the US FDA had accepted their new drug application filing for NOV03 (perfluorohexyloctane), an eye drop candidate for dry eye associated with meibom...

TearLab Changes Name to Trukera Medical, Plans Further Expansion into Corneal Health
TearLab Changes Name to Trukera Medical, Plans Further Expansion into Corneal Health

TearLab announced Sept. 7 that it will be expanding its position in corneal health under the new name Trukera Medical. Trukera, of Escondido, California, develops and markets laboratory point-of-ca...

iOR Partners Appoints James R. Williams as President and CEO
iOR Partners Appoints James R. Williams as President and CEO

iOR Partners, the Kansas City company pioneering office-based surgery in ophthalmology, announced Sept. 7 that it had appointed James R. Williams to serve as the company’s new president and CEO. Wi...

Ray Therapeutics Appoints Peter Francis, MD, as Chief Scientific and Medical Officer
Ray Therapeutics Appoints Peter Francis, MD, as Chief Scientific and Medical Officer

Ray Therapeutics, of San Francisco, announced Sept. 6 that it had appointed Peter Francis, MD, PhD, as chief scientific and medical officer. Francis was trained in the UK, obtaining his PhD in opht...

California Legislature Passes Bill to Expand Scope of Practice for ODs
California Legislature Passes Bill to Expand Scope of Practice for ODs

The California Legislature has passed a bill to allow optometrists in the state to perform several laser procedures on the eye. The bill—AB 2236: “Optometry: Certification to Perform Advanced Proce...

Tepezza Patient Sues Horizon, Says Extent of Hearing Loss Risk Wasn’t Disclosed
Tepezza Patient Sues Horizon, Says Extent of Hearing Loss Risk Wasn’t Disclosed

A man in Arizona sued Horizon Therapeutics on Aug. 25, alleging that the company failed to inform regulators that its thyroid eye disease medication Tepezza can cause permanent ear ringing and hear...

EU Regulators Approve Teva’s Lucentis Biosimilar, Branded Ranivisio
EU Regulators Approve Teva’s Lucentis Biosimilar, Branded Ranivisio

Teva Pharmaceutical Industries announced Aug. 29 that the European Commission had granted marketing authorization for its Ranivisio (ranibizumab injection), a biosimilar of Lucentis. Ranivisio is a...

Outlook Resubmits BLA for Ophthalmic Bevacizumab Candidate ONS-5010 in Wet AMD
Outlook Resubmits BLA for Ophthalmic Bevacizumab Candidate ONS-5010 in Wet AMD

Outlook Therapeutics reported Aug. 30 that it had resubmitted its biologics license application (BLA) to the US FDA for its ophthalmic bevacizumab candidate ONS-5010 in wet age-related macular dege...

Bausch + Lomb Announces Collaborations in Ocular Dyes, Digital Microscopy
Bausch + Lomb Announces Collaborations in Ocular Dyes, Digital Microscopy

Bausch + Lomb is collaborating with two European companies to expand its ophthalmic portfolio. The Canada-based Bausch Health subsidiary reported on Sept. 1 that it had become the exclusive global ...

White House Makes Publicly Funded Research Open Access
White House Makes Publicly Funded Research Open Access

The Biden administration on Aug. 25 directed federal agencies to make published research from studies funded with taxpayer dollars available immediately for free after it is published. The directiv...

Iantrek Raises $23 Million in Series B to Advance Implant-Free Glaucoma Surgical Technologies
Iantrek Raises $23 Million in Series B to Advance Implant-Free Glaucoma Surgical Technologies

Iantrek Inc., of White Plains, New York, announced Aug. 30 that it had closed a $23 million Series B financing. Iantrek, founded by Sean Ianchulev, MD, said it is the only company with US FDA-regis...

Opthea Closes First Tranche of $41.9 Million in Equity Financing
Opthea Closes First Tranche of $41.9 Million in Equity Financing

Australia’s Opthea reported Aug. 30 that it had closed the first tranche—$41.9 million—of a $90 million two-tranche placement of ordinary shares. MST Financial and Jefferies LLC acted as joint lead...

OKYO Plans Q4-2022 IND Filing for OK-101 in Dry Eye
OKYO Plans Q4-2022 IND Filing for OK-101 in Dry Eye

London’s OKYO Pharma announced Aug. 30 that it plans to submit an investigational new drug (IND) application to the US FDA in Q4-2022 for its topical dry eye treatment candidateOK-101. OK-101 consi...

Alcon Buys Aerie in $770 Million Deal, Aims to Boost Sales of Rocklatan, Rhopressa
Alcon Buys Aerie in $770 Million Deal, Aims to Boost Sales of Rocklatan, Rhopressa

Alcon announced Aug. 22 that it will acquire Aerie Pharmaceuticals in a deal valued at $770 million. Alcon will pay $15.25 a share for Aerie stock, a premium of 37 percent over Aerie’s last closing...

Glaukos Licenses iVeena’s Investigational Keratoconus Therapy
Glaukos Licenses iVeena’s Investigational Keratoconus Therapy

iVeena Delivery Systems announced Aug. 24 that it had granted Glaukos an exclusive global license to develop and commercialize IVMED-80, a pharmacologic treatment candidate for keratoconus. Keratoc...

Bausch + Lomb Separation Plan Continues, as Bausch Health Considers Strategic Alternatives
Bausch + Lomb Separation Plan Continues, as Bausch Health Considers Strategic Alternatives

Bausch Health, of Laval, Quebec, reported Aug. 22 that it continued to take steps consistent with plans to separate eye care subsidiary Bausch + Lomb, but Bausch Health also engaged financial and l...

CMS Proposes Cuts to Ophthalmologists’ Fees in 2023, Increase in Facility Payments
CMS Proposes Cuts to Ophthalmologists’ Fees in 2023, Increase in Facility Payments

US Medicare payments to ophthalmologists would decline in 2023 under cuts proposed in July by the Centers for Medicare & Medicaid Services (CMS). At the same time, facility payments for ASCs and ho...

Belite Bio Initiates US Phase III Trial of Stargardt Candidate
Belite Bio Initiates US Phase III Trial of Stargardt Candidate

Belite Bio announced Aug. 22 that it had begun enrollment in a US Phase III trial of LBS-008 (tinlarebant), its oral treatment candidate for Stargardt disease. There is no approved treatment for St...

Sight Sciences Launches SION Bladeless Instrument for Goniotomy
Sight Sciences Launches SION Bladeless Instrument for Goniotomy

Sight Sciences announced Aug. 23 that it had launched the SION, a bladeless glaucoma surgical instrument for goniotomy. The Menlo Park, California, company said the SION excises trabecular meshwork...

Digital Diagnostics Closes $75 Million Series B Funding Round
Digital Diagnostics Closes $75 Million Series B Funding Round

Digital Diagnostics, formerly IDx, announced Aug. 23 that it had closed a $75 million Series B funding round. The company’s flagship product is IDx-DR, a US FDA approved, autonomous AI diagnostic s...

Valo Health Doses First Patient in Phase II Study of Oral Treatment Candidate for NPDR
Valo Health Doses First Patient in Phase II Study of Oral Treatment Candidate for NPDR

Valo Health, of Boston, announced Aug. 18 that it had begun dosing in a Phase II study of OPL-0401, its oral treatment candidate for nonproliferative diabetic retinopathy (NPDR). OPL-0401 is a smal...

2022 OIS Retina Shines Light on Startup Funding Climate
2022 OIS Retina Shines Light on Startup Funding Climate

Innovation, breakthrough technologies, and the difficult funding environment for startups were some of the topics addressed at the OIS Retina Innovation Summit in New York. It was held the day befo...

Scleral Buckles are Surprising Stars of 2022 ASRS Meeting
Scleral Buckles are Surprising Stars of 2022 ASRS Meeting

The humble scleral buckle captured surgeons’ attention at the 2022 conference of the American Society of Retina Specialists (ASRS). Scleral buckle surgery figured in six of the 142 symposia podium ...

Safer and More Effective Glaucoma Surgical Options Expected to Double Global Revenue by 2027
Safer and More Effective Glaucoma Surgical Options Expected to Double Global Revenue by 2027

Nearly 48 million individuals are diagnosed with glaucoma globally, but just over a million, or 2.2 percent, will have surgery in 2022. However, safer and more effective surgical devices over the n...

Lions Eye Institute’s Acquisition of SightLife Could Help Bridge Cornea Transplant Gap
Lions Eye Institute’s Acquisition of SightLife Could Help Bridge Cornea Transplant Gap

Lions Eye Institute for Transplant and Research announced Aug. 10 that it would acquire SightLife, the world’s leading nonprofit eye bank. Combined, the two nonprofits would create the largest eye ...

US FDA Approves Coherus’ Lucentis Biosimilar, Branded Cimerli
US FDA Approves Coherus’ Lucentis Biosimilar, Branded Cimerli

Coherus BioSciences announced Aug. 2 that the US FDA had approved Cimerli (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis (ranibizumab injection). Cimerli is approved for a...

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