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FDA Announces New Commissioner

Stephen Hahn, MD, was sworn in as the twenty-fourth commissioner of the FDA on Dec. 17. Hahn replaces Gottleib, who resigned in April 2019. Hahn is an oncologist; he completed a residency and a fel...

InfuTronix Pump Controls Post-Op Pain After Extremity Surgery

Patients who underwent upper or lower extremity surgery were given a Nimbus II PainPro infusion pump from InfuTronix Solutions and achieved positive results, confirmed a study Dec. 19. The Nimbus I...

RTI Surgical’s SImmetry System Gains Cigna Coverage

RTI Surgical announced Dec. 16 that Cigna has issued a positive coverage policy for sacroiliac joint fusion using all FDA-cleared devices, including RTI’s SImmetry system. RTI obtained SImmetry thr...

RTI’s Tetrafuse PEKK Achieves Positive Preclinical Results

Preclinical results for RTI Surgical’s Tetrafuse PEKK (polyetherketoneketone) material in an ovine model were announced Dec. 17. PEKK implants were found to have significantly greater bony appositi...

Aldeyra Enrolls First Patient in Phase III Trial for Proliferative Vitreoretinopathy

Aldeyra Therapeutics of Lexington, Massachusetts, announced Dec. 19 the enrollment of the first patient in its Phase III GUARD trial of ADX-2191 for the prevention of proliferative vitreoretinopath...

Democrats Ask Supreme Court for Expedited Review of Latest ACA Case

The Democratic-controlled US House and 20 Democratic-led states asked the US Supreme Court on Jan. 3 for expedited review of the constitutionality of the Affordable Care Act (ACA), seeking a decisi...

DORC Gains US Approval for TissueBlue to Stain Internal Limiting Membrane

Dutch Ophthalmic Research Centre (DORC) announced Jan. 6 that it has received US FDA approval for its TissueBlue (Brilliant Blue G) dye to stain the internal limiting membrane (ILM) in vitreoretina...

GenSight Raises $16.7 Million Through Bond Issue, Reserved Capital Increase

GenSight Biologics, of France, announced Dec. 20 that it had obtained a bond financing of up to €12 million (US $13.4 million) from Kreos Capital—with a first tranche of €6 million (US $6.7 million...

Lineage Sells Shares in OncoCyte, Nets $5 Million

Lineage Cell Therapeutics announced Jan. 2 that it had sold nearly 2.4 million shares of common stock of OncoCyte at $2.66 per share. Net proceeds from the sale were $5 million. The sale was expect...

Nicox’ NCX 4251 Meets Primary Endpoint in Phase II Blepharitis Trial, and Shows Promise in Dry Eye Disease

Nicox announced Dec. 19 that NCX 4251, its patented ophthalmic suspension of fluticasone propionate nanocrystals, had met the primary objective of its US multicenter, first-in-human Phase II clinic...

Transplanted Retinal Cells Pre-treated with ProtoKinetix AAGP Showed Improvement in Survival, Function

Marietta, Ohio-based ProtoKinetix announced Dec. 19 that it had completed an in vivo study to assess the effect of its anti-aging glycoprotein (AAGP) on the long-term survival and functional activi...

Carl Zeiss Meditec Completes Recall of Plex Elite 9000 OCT Over Risk of Shock

The US Food and Drug Administration (FDA) recently announced that Carl Zeiss Meditec had completed a Class II recall of its Plex Elite 9000 swept-source optical coherence tomography (OCT) system, c...

Ophthalmic Deals Surge in 2018-2019; Most Transactions Involve New Ventures

Ophthalmic deals garnered over $9 billion from January 2018 through October 2019, driven largely by dry eye and retina related fundraising. Over 100 transactions occurred during this period, and ov...

European Ophthalmic Device Innovation May Slow During MDR Transition

The wave of new intraocular lenses (IOLs) introduced in Europe in 2019 may represent the storm before the calm. The introduction of new regulations, and the rush to beat them, may insulate the Euro...

Hensler Surgical Sues Tobra Medical

Hensler Surgical filed a patent infringement lawsuit against Tobra Medical, the company announced Dec. 12. Hensler’s product, Bone Press®, is closely mimicked by Tobra’s Bone Basket. Both are used ...

Canada’s 2019 Health Care Wait Time Was Second Longest on Record

The Fraser Institute announced Dec. 10 that the median wait time for medically necessary treatment in Canada was 20.9 weeks in 2019. This is the second longest wait since the Institute began collec...

HSS Supports Medical Center in Cartagena, Colombia

The Hospital for Special Surgery issued a press release Dec. 9, stating that it will provide a “medical bridge” to the Centro Hospitalario Serena del Mar in Cartagena, Colombia. The collaboration w...

IMAC Introduces Wellness Programs

IMAC Holdings announced Dec. 5 that it will offer three different wellness subscription programs, starting January 2020. All patients of IMAC’s Regenerative Medicine Treatment Centers will be eligi...

Bausch Health Licenses Novaliq’s Treatment for Dry Eye Disease Associated with Meibomian Gland Dysfunction

Bausch Health announced Dec. 20 that it had licensed Novaliq’s investigational treatment NOV03 (perfluorohexyloctane) for dry eye disease associated with meibomian gland dysfunction for commerciali...

Bausch + Lomb Introduces enVista Toric MX60ET IOL

Bausch + Lomb has introduced the enVista toric MX60ET, an enhanced hydrophobic acrylic intraocular lens (IOL) for cataract patients who have astigmatism. The New Jersey company, a division of Bausc...

Novartis Receives Permanent J-code for Beovu

Novartis announced that it has received a permanent J-code in the United States for Beovu (brolucizumab-dbll) injection, effective Jan. 1. J-codes are reimbursement codes used by commercial insuran...

‘Today’ Show’s Savannah Guthrie and Her Ophthalmologist Provide Update after Surgery for Retinal Tear

“Today” show host Savannah Guthrie updated colleagues and viewers on her retinal tear Dec. 18, following surgery a week earlier. She was speaking by phone, while her ophthalmologist, Donald D’Amico...

Catalyst and Biogen Agree to Co-develop C3 Inhibitor for GA

Catalyst Biosciences and Biogen have agreed to co-develop Catalyst’s pegylated CB 2782 (CB 2782-PEG), a C3 inhibitor, for the treatment of geographic atrophy, an advanced form of dry age-related ma...

SEED Co. Acquires Majority Stake in Sensimed After Years of Collaboration

Sensimed, of Lausanne, Switzerland, announced Dec. 13 that contact lens maker SEED Co. had acquired a majority stake and now owned 90 percent of Sensimed’s outstanding shares. Sensimed said it will...

Oxurion Shifts Focus from Growth Factor Inhibitors to Other Mechanisms of Action for DME

Belgium-based Oxurion announced Dec. 19 that it plans to focus on candidates for diabetic macular edema (DME) that don’t target vascular endothelial growth factor (VEGF), a signaling protein that p...

Achillion Shareholders Approve Sale of Company to Alexion

Achillion Pharmaceuticals’ shareholders have approved the company’s plans to be acquired by Alexion Pharmaceuticals. Achillion, of Blue Bell, Pennsylvania, said Dec. 19 that it expected the deal to...

Study Indicates the Brain Can Combine Natural Vision with Artificial Signals from Implant in AMD

A study by researchers at Israel’s Bar-Ilan University and Stanford University indicates that the brain can combine natural and artificial vision when a retinal prosthesis is used to treat the loca...

Lineage Sees Positive Results in Phase I/IIa Study of OpRegen for Dry AMD

Lineage Cell Therapeutics reported on Dec. 30 encouraging results from its ongoing Phase I/IIa clinical study of OpRegen, the company’s retinal pigment epithelium transplant therapy, for the treatm...

American Diabetes Association Updated Standards of Care Now Include AI Retinal Screening

The American Diabetes Association (ADA) has released a new set of clinical standards that for the first time include the use of autonomous artificial intelligence. The ADA's 2020 Standards of M...

Global Refractive Surgery Demand Continues to Grow in 2019

Economic conditions have improved in major markets, which continues to help grow the global demand for refractive surgery, along with the popularity of newer technology, such as lenticular extracti...

Lumibird to Buy Ellex Laser and Ultrasound Business for $69.3 Million

France-based Lumibird announced Dec. 23 that it agreed to acquire the laser and ultrasound business of Ellex Medical Lasers for $69.3 million (AU $100 million or €62 million). Ellex, of Adelaide, A...

Medical Device Tax is Repealed Permanently in US

The much-maligned medical device excise tax was repealed Dec. 20 in one of two US spending bills signed by the president. The repeal, spelled out in Section 501 of H.R. 1865, begins in January 2020...

FocalPoint’s 8 Thousand Ophthalmology and Optometric Providers Will Offer GreenSky Financing

FocalPoint Holdings and patient financing company GreenSky are partnering to offer flexible financing solutions to patients of FocalPoint’s 8 thousand ophthalmology and optometry providers, the com...

3D-Printed Bones Head to Clinical Trials

ADAM Project, a member of the BioCT accelerator in Connecticut, announced Dec. 3 that it will be testing its bioresorbable ceramic- and polymer-based 3D-printed bone prototypes in humans by the end...

HSS Opens 14-Thousand-Square-Foot Outpatient Center in Brooklyn

The Hospital for Special Surgery (HSS) opened a new 14-thousand-square-foot musculoskeletal care outpatient clinic in Brooklyn’s Industry City in December. The facility is designed to provide non-o...

IntuitiveX and NavLab Collaborate on Robotics

Seattle-based IntuitiveX announced Nov. 22 that it is collaborating with NavLab to create additional IP for surgical robotics. NavLab is a portfolio company of IntuitiveX. One of the new patents de...

Virtual TKA Models May Replace Cadaveric Ones

Nana Sarpong et al. published results in The Knee on Nov. 21, showing that virtual posterior cruciate ligament (PCL) models may be able to test TKA implants without the use of cadavers. Sarpong’s t...

S+N Announces Positive Results for Its Regeneten

Large and massive rotator cuff tears have been successfully treated by Smith+Nephew’s Regeneten Bioinductive implant, according to results from a clinical study announced Nov. 19. Regeneten is a co...

Bausch + Lomb Initiates Clinical Trial Evaluating New Cohesive OVD

Bausch + Lomb announced Dec. 17 that it had initiated a clinical trial evaluating the safety and efficacy of a new cohesive ophthalmic viscosurgical device (OVD). The company said the new OVD is in...

New Cell Models for Ocular Drug Discovery

Researchers at the University of Eastern Finland announced Dec. 4 that they had developed two new cell models that can open up new avenues for ocular drug discovery. The new cell models continuousl...

NIH Launches First US Trial of Patient-Derived Stem Cell Therapy to Replace Dying Cells in Retina

Researchers at the National Eye Institute (NEI) are launching a clinical trial to test the safety of patient-specific stem cell-based therapy to treat geographic atrophy, the advanced dry form of a...

Optina Partners with Marubeni to Bring Early Dementia Retinal Test to Japan

Marubeni Corporation and Optina Diagnostics agreed to enter into a development partnership to bring Optina’s early dementia diagnosis platform to the Japanese market, the companies announced Dec. 4...

RightEye Vision System Receives Breakthrough Designation from FDA for Parkinson’s Disease

RightEye announced Dec. 3 that its eye-tracking technology had received breakthrough device designation from the FDA as a test for Parkinson’s disease. The designation is designed to streamline the...

KalVista’s DME Candidate Fails to Meet Primary Endpoint in Phase II Trial

KalVista Pharmaceuticals, of Cambridge, Massachusetts, and Salisbury, England, announced Dec. 9 that its candidate, KVD001, for diabetic macular edema (DME) had failed to meet its primary endpoint ...

CHMP Backs Beovu as Treatment for Wet AMD in the European Union

Novartis announced Dec. 13 that it received a positive opinion for Beovu (brolucizumab) as a treatment of wet AMD from the EMA’s Committee for Medicinal Products for Human Use (CHMP). The European ...

Roche Completes $4.4 Billion Acquisition of Spark Therapeutics

Roche completed its $4.4 billion acquisition of Spark Therapeutics on Dec. 17 after gaining regulatory approval and obtaining 60.4 percent of Spark’s outstanding common stock the previous day. Roch...

FDA Advisory Panel Backs Horizon’s Teprotumumab for Thyroid Eye Disease

A US FDA advisory panel has unanimously backed Horizon Therapeutics’ teprotumumab for the treatment of thyroid eye disease (TED). TED is a rare, progressive, and vision-threatening autoimmune disea...

J&J Vision Introduces TECNIS Toric II 1-Piece IOL, Aiming to Cut Down Rotation

Johnson & Johnson Vision announced Dec. 3 the US Food and Drug Administration (FDA) approval and US launch of its TECNIS Toric II 1-Piece Intraocular Lens (IOL). The company, of Santa Ana, Californ...

Oncologist Stephen Hahn Confirmed as US FDA Commissioner

The US Senate voted 72 to 18 on Dec. 12 to confirm President Donald Trump’s nominee, Stephen Hahn, MD, as the next FDA commissioner. The radiation oncologist, who was recently cleared by the Senate...

1-800 Contacts Will Acquire Israeli Startup 6over6 Vision

1-800 Contacts, of Draper, Utah, announced Dec. 17 that it had entered into a definitive written agreement to acquire 6over6 Vision Ltd. The deal is expected to close before the end of December 201...

Ophthalmic Surgical Instruments Market to Top $1.7 Billion in 2024, Driven by Growth in Procedures, Adoption of Disposable Versions

The global ophthalmic surgical instruments market is expected to exceed $1.7 billion in revenue in 2024, increasing at a compound annual rate of 4.4 percent from 2019 revenue of more than $1.4 bill...

Surgeons Report 6.7 Percent Growth in Q3-2019 US Ophthalmic Procedures

US ophthalmologists reported that ophthalmic procedures increased 6.7 percent in Q3-2019 compared with the same quarter last year, according to Market Scope’s latest surveys. Growth was sporadicall...

Ophthalmic Company Revenue Rises 7.5 Percent in Third Quarter of 2019

Public company reports are in for Q3-2019, and overall ophthalmic revenue totaled $9.3 billion, an increase of 7.5 percent over the same quarter last year. The total includes Market Scope estimates...

Avellino Labs Continues Push for Full Launch of Genetic Test in 2020

Avellino Labs’ launch of its groundbreaking genetic test for keratoconus and corneal dystrophies is a turning point for a company with ambitious plans for 2020 and beyond. The year ahead will inclu...

Aerie Pays $10 Million Up Front to Buy Spanish Company Working on Dry Eye

Aerie Pharmaceuticals, of Durham, North Carolina, has signed an agreement for the acquisition of Avizorex Pharma (AVX), a Spanish company developing therapeutics for the treatment of dry eye diseas...

BVI Buys Arcadophta, Specialist in Oils and Gases Used in Vitreoretinal Surgery

Beaver-Visitec International (BVI), of Waltham, Massachusetts, announced Dec. 6 that it had acquired Arcadophta—also known as Arcad, an ophthalmic company specializing in silicon oils, gases, and p...

Kodiak Leads Latest Fundraising Efforts with $500 Million in Financing

Kodiak Sciences led recent fundraising efforts by ophthalmic companies, recently raising potentially more than $500 million in a public offering and royalty rights deal with Baker Bros. Advisors. O...

Roche Completes $4.4 Billion Acquisition of Spark Therapeutics

Global Refractive Surgery Demand Continues to Grow in 2019

Baring Private Equity Asia to Acquire Lumenis, Values Laser Company at over $1 Billion

Hong Kong’s Baring Private Equity Asia announced Nov. 19 that its affiliated funds have agreed to acquire Israel-based Lumenis, maker of ophthalmic lasers and other energy-based medical devices, fr...

FDA Advisory Panel Backs Horizon’s Teprotumumab for Thyroid Eye Disease

FDA Approves First Contact Lens to Slow Progression of Myopia in Children

The US Food and Drug Administration (FDA) approved on Nov. 15 the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 at the in...

European Ophthalmic Device Innovation May Slow During MDR Transition

Frinzi Retires from J&J Vision’s Surgical Division; Faust Assumes Role

Johnson and Johnson Vision announced Dec. 4 that industry veteran Tom Frinzi was retiring from his role as worldwide president of surgical vision. Warren Faust officially stepped into the role Dec....

Emerging Companies Pursuing Ophthalmic Indications, December 2019

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease. Company Location About Ocular Science Los Angeles The company, founded in 2015, provides com...

IDx-DR Autonomous AI Diagnostic System Launches in Retail Health Clinics

Patients at CarePortMD retail health clinics at Albertsons grocery stores now have access to a diabetic retinopathy eye exam performed with the FDA-cleared autonomous AI diagnostic system IDx-DR. A...

Market Scope Weekly Ophthalmic Surgeon Poll for December 2019

December 2019 Ophthalmic News Briefs

Glaukos, maker of iStent implants for glaucoma, announced Nov. 21 that it completed its acquisition of Avedro, a Waltham, Massachusetts-based developer of corneal cross-linking, in an all-stock tra...

Ophthalmic Surgical Instruments Market to Top $1.7 Billion in 2024, Driven by Growth in Procedures, Adoption of Disposable Versions

Aurinia Raises $191.7 Million in Public Offering of Stock

Aurinia Pharmaceuticals, focused on advancing voclosporin in multiple indications, including dry eye, announced Dec. 12 that it had raised $191.7 million, before expenses, in an underwritten public...

Aurinia Applies Pressure in Race to Market Next Dry Eye Pharmaceutical Drug in US

Aurinia Pharmaceuticals’ initiation of its Phase II/III AUDREY trial in dry eye keeps Aurinia in the middle of the pack of companies racing to develop the next pharmaceutical treatment for dry eye ...

BVI Buys Arcadophta, Specialist in Vitreoretinal Surgery Oils and Gases

Patient in France Granted Temporary Authorization for GenSight’s LHON Gene Therapy

The National Eye Hospital in Paris and French company GenSight Biologics announced Dec. 9 that that the French Competent Authority granted a patient Temporary Authorization for Use for Lumevoq, Gen...

Limelight Bio Secures $75 Million to Develop Next Generation Gene Therapies

Limelight Bio announced Dec. 5 that it had raised $75 million in new financing funded by Apple Tree Partners (ATP), a leading life sciences innovation fund. Limelight Bio, with operations in Philad...

Study Links Air Pollution to Higher Glaucoma Risk

People in neighborhoods with higher amounts of fine particulate matter pollution were more likely to report having glaucoma than those in the least-polluted areas, according to a study in Britain. ...

Regeneron’s Eylea Injection Prefilled Syringe Now Available

Regeneron, of Tarrytown, New York, has announced that the Eylea (aflibercept) prefilled syringe is now available for doctors to order. The 2 mg, single-dose, sterilized prefilled syringe requires f...

Omeros Raises $57.5 Million in Sale of Shares, Exercise of Option

Omeros announced Dec. 13 the full exercise and closing of the sale of 572,518 shares of common stock to the underwriter of its previously announced public offering. When combined with shares sold i...

Notal Vision Secures $25 Million for ForeseeHome and Pipeline Technologies

Notal Vision announced Dec. 11 that Ganot Capital was extending its recent funding round to $25 million. The company said the continued investment would enable Notal Vision to support the commercia...

Study Links Air Pollution to Higher Glaucoma Risk

Frinzi Retires from J&J Vision’s Surgical Division; Faust Assumes Role

NBC’s Savannah Guthrie Treated for Retinal Tear from Accident with Toy

NBC “Today” show host Savannah Guthrie updated viewers Dec. 2 on an injury to her right eye a week earlier. Son Charley hit her in the right eye with a toy train, leaving Guthrie with blurred visio...

Aerie Seeks Approval to Sell Roclanda (Rocklatan) in EU

Aerie Pharmaceuticals announced Dec. 3 that it had submitted a marketing authorization application for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% to the European Medicin...

EnChroma Donates Glasses to Help Color Blind Students at School District in Minnesota

Color blind students at Lakeview School District in Cottonwood, Minnesota, will have access to EnChroma glasses for color blindness to help them surmount the challenges color vision deficiency can ...

Kodiak Announces Public Offering and Royalty Rights Deal Worth Potentially More than $500 Million

Kodiak Sciences plans to raise half a billion dollars through two fundraising moves to accelerate development of KSI-301. The Palo Alto, California, company announced Dec. 3 that it had commenced a...

Light-Sensitive Ganglion Cells Talk with Each Other, Appear to Enhance Nonvisual Behaviors, Research Indicates

Scientists have known since 2007 that a small percentage of ganglion cells—the cells in the retina that send messages through the optic nerve to the brain—are sensitive to light, in addition to con...

Opthea Sells $34.2 Million in Shares to Raise Funds for Phase III Trial of Wet AMD Candidate

Opthea said it has received commitments to raise US $34.2 million (AU $50 million) for the development of OPT-302 as a therapy for wet age-related macular degeneration (wet AMD). The Australian com...

Ophthalmic Deals Surge in 2018-2019; Most Transactions Involve New Ventures

ProQR’s QR-1123 Receives FDA Orphan Drug Designation for Autosomal Dominant Retinitis Pigmentosa

ProQR Therapeutics, of Leiden, Netherlands, has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for QR-1123, the company announced Nov. 21. QR-1123 is a first-...

ProtoKinetix Begins Studying its AAGP Molecule for Dry Eye

Marietta, Ohio-based ProtoKinetix is developing a family of highly stable, potent glycopeptides (branded AAGP) intended to fight cell death, aging, and inflammation, and dry eye is a target, the co...

Positive Phase III Results for Roche’s Satralizumab in Neuromyelitis Optica Spectrum Disorder

Positive results from a pivotal Phase III study of satralizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD) were published online Nov. 27 in the New England Journal of Medic...

Second Sight Reports Four Implantations of Argus II Prostheses in Q3-2019

Second Sight reported Nov. 14 that surgeons in Q3-2019 implanted four Argus II retinal prostheses at an average selling price of $118 thousand. This compares with 22 implants at an average selling ...

ViGeneron Closes Series A Round to Advance Ophthalmic Gene Therapy Programs

German company ViGeneron announced Nov. 28 that it closed a Series A financing to accelerate development of its two lead ophthalmic gene therapy programs for undisclosed indications. Investors WuXi...

Orthopedic US FDA 510(k) Clearances

During the past month, 53 orthopedic devices have received FDA 510(k) clearance. Fifteen of the devices are spine implants. Six of these are for fixation: three plates and three rod and screw syste...

Hip Arthroplasty Procedures Forecast to Grow 6.4 Percent Annually Through 2024

Hip arthroplasty procedures are increasing worldwide due to a growing elderly population that is prone to osteoarthritis (OA) and expanding access to advanced medical care in underserved markets su...

Monthly Orthopedic Deals Topped by $5.4B Acquisition

Three notable orthopedic deals took place between Oct. 15 and Nov. 15, the largest being the acquisition of Wright Medical by Stryker. The $5.4 billion deal is expected to close in the second half ...

AAHKS Meeting Draws Over 4 Thousand to Dallas

More than 4 thousand doctors attended the sixth annual meeting of the American Association of Hip and Knee Surgeons from Nov. 7-10 at the Hilton Anatole in Dallas, Texas. AAHKS President Michael P ...

Neuromodulation Revenue Clouds Otherwise Healthy Third Quarter

Orthopedic industry revenue increased 4.5 percent in Q3-2019 when compared with Q3-2018. All segments exhibited single-digit growth except neuromodulation. Compared with the same quarter last year,...

Glaukos Completes Acquisition of Corneal Cross-Linking Developer Avedro

Glaukos, maker of the iStent inject, announced Nov. 21 that it has completed its previously announced acquisition of Avedro, developer of corneal cross-linking. Thomas Burns, Glaukos president and ...

Roche Again Extends Tender Offer for Shares in its Bid to Acquire Spark

Roche once again delayed its tender offer for the $4.3 billion acquisition of Spark Therapeutics. “[T]o provide additional time for the US Federal Trade Commission (FTC) and the UK Competition and ...

Study Finds Increase in Pediatric Eye Injuries from Nonpowder Firearms

Eye injuries from nonpowder firearm incidents are on the rise in the United States, according to a new study by researchers at the Center for Injury Research and Policy at Nationwide Children’s Hos...

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