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McGuire Steps Down as CEO of Second Sight; Chairman Williams Takes Over as Interim Chief
Second Sight Medical Products CEO Will McGuire is leaving the company to accept a similar role at Ra Medical, a Carlsbad, California, medical device company focusing on commercializing excimer lase...
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Lenstec Submits PMA Application to FDA for SBL-3 Segmented Bifocal Lens
Lenstec announced March 16 that had submitted a premarket approval application to the US FDA for its SBL-3 presbyopia-correcting intraocular lens (PC-IOL). The SBL-3 would be the first segmented bi...
Horama Licenses Retinal Gene Therapy Candidate from Leiden University
French ophthalmic gene therapy company Horama announced March 18 that it licensed from Leiden University Medical Center an adeno-associated viral (AAV) gene therapy program to treat inherited retin...
Graybug Ends Phase IIb Enrollment Early After Confirming Dosing Regimen
Graybug Vision announced March 18 that it had closed enrollment early in its Phase IIb trial of GB-102 (1 or 2 mg) in wet age-related macular degeneration (AMD), because the company intends to move...
Eyenovia Raises $5.3 Million in Private Placement for Microdose Candidates
Eyenovia reported March 25 that it raised $5.3 million in net proceeds in a private placement of units made up of common stock and warrants. The company said it intends to use the proceeds, togethe...
COVID-19 Update: OCTANe Summit, AAPOS Meeting, Industry Announcements
OCTANe has moved its Ophthalmology Technology Summit to July 31 from June 26 due to the pandemic, the group announced on its website. The Fashion Island Hotel in Newport Beach, California, remains ...
RSIP Vision Releases 3D Knee Reconstruction Technology That Uses Radiographs
RSIP Vision announced March 16 that its AI-based 3D reconstruction solution for knees is available. The technology takes pre-op X-rays and converts them into 3D anatomical models that can be used t...
CMS Proposes the Addition of Outpatient THA and TKA to Bundled Payment Plan
CMS published a proposed rule on March 5, suggesting that outpatient knee and hip replacement surgeries (TKA and THA, respectively) be added to the Comprehensive Care for Joint Replacement (CJR) Mo...
FDA Releases Third-Party Reviewer Guidelines
The FDA announced March 12 that it has released guidance for the 510(k) Third-Party Review Program, also known as 3P510k Review Program. Qualified third-party programs review premarket notification...
Study Shows Post-Traumatic Arthritis Has Larger Impact on TKA Complications Than OA
A study by Brockman et al., published in the Journal of Arthroplasty in Feb., compared TKA outcomes for 14,206 patients with post-traumatic arthritis and 1,287,188 patients with osteoarthritis (OA)...
Patients Will Have Access to Personal Health Data Under New HHS Rules
The HHS and CMS finalized two new rules, announced March 10, that will require providers to give secure, free access to health information for patients. Under the new rules, patients will be able t...
FDA Publishes Final Guidance for Bone Anchors
On March 7, the FDA released its final guidance for bone anchor 510(k) submissions. The guidelines include necessary submission requirements and recommended methods for bench testing. Specifically,...
Episealer Knee Implant Achieves Positive Results in 30-Patient Study
Episurf Medical announced March 8 that its Episealer implant for focal cartilage and osteochondral defects on the femoral side of the knee joint performed well in an independent Swedish study. Epis...
Sight Sciences Raises More than $30 Million in Series E Round
Sight Sciences announced March 18 that it closed a Series E preferred stock financing round of more than $30 million. The Menlo Park, California, company said proceeds will be used for continued cl...
Alcon Launches Vivity PC-IOL in Select European Countries
Alcon announced March 12 that it launched its Vivity presbyopia-correcting intraocular lens (PC-IOL) in select European countries, with additional market launches coming throughout 2020. The eye ca...
Disappointing Phase IIa Results Lead Santen, TRACON to Scrap DE-122 for Wet AMD
Santen Pharmaceutical, of Japan, and TRACON Pharmaceuticals, of San Diego, announced March 9 that they had discontinued the development of DE-122 (carotuximab) for the treatment of wet age-related ...
COVID-19 Update: Kiawah Eye Meeting Delayed; Novartis Donates 130 million Doses of Drug for Pandemic
The organizers of the 2020 Kiawah Eye meeting have rescheduled it for Sept. 10-12, 2020, at the Kiawah Island Resort in South Carolina. “These next few weeks remain uncertain at this time, and we f...
Rayner Surgical Group for Sale, UK News Outlets Report
Rayner Surgical Group, the only British manufacturer of intraocular lenses, is for sale for £300 million to £400 million, according to UK news outlets. The Daily Mail reported March 7 that buyout s...
Clearside Licenses Xipere to Arctic Vision for Greater China and South Korea
Clearside Biomedical announced March 11 that Arctic Vision, of China, had acquired an exclusive license for the development and commercialization of Xipere (triamcinolone acetonide suprachoroidal i...
Harrow Health Reports 2019 Net Revenue of $51.2 Million
Harrow Health reported March 13 that full year 2019 consolidated net revenue totaled $51.2 million, a 23.7 percent increase over 2018 revenue of $41.4 million. Q4-2019 net revenue was $12.6 million...
Everads Therapy Licenses Suprachoroidal Delivery System to Global Pharma Company
Everads Therapy, of Israel, announced March 12 that it had licensed its suprachoroidal delivery system to a global pharmaceutical company. The deal was Everads’ first commercial agreement. Under th...
Omeros Reports Full Year 2019 Revenue of $111.8 Million
Omeros announced March 2 that its full year 2019 revenue was $111.8 million, a 274 percent increase from $29.9 million for full year 2018. The Seattle-based developer of Omidria said the significan...
COVID-19 Update: AAO Advises Only Urgent Surgery, ASCRS Cancels Meeting
The American Academy of Ophthalmology announced March 18 that it is now “essential that all ophthalmologists cease providing any treatment other than urgent or emergent care immediately” to reduce ...
Ophthalmic Company Revenue Increases 6.8 Percent in Fourth Quarter of 2019
Overall ophthalmic revenue in Q4-2019 totaled $9.8 billion, an increase of 6.8 percent over the same quarter last year. The total included Market Scope estimates for private companies and excluded ...
Oculis Reaches for ‘Holy Grail’ of Topical Retinal Medication
Retina specialist Pravin Dugel, MD, told Market Scope in a phone interview March 5 that Swiss company Oculis is approaching “the holy grail for topical technologies.” A Phase II study, DX-211, demo...
Ophthalmologists Report 6.8 Percent Growth in Q4-2019 Procedure Volume
US ophthalmologists reported that ophthalmic procedures increased 6.8 percent in Q4-2019 compared with the same quarter last year, according to Market Scope’s latest surveys. Growth was sporadicall...
New Research Incentives Bolster Participation at AIOS Conference
The one word to describe the All India Ophthalmological Society Congress (AIOC) held in February in Gurugram is “more.” There were more attendees, more scientific papers, and more new products than...
US Launch of Alcon PanOptix Trifocal Lens Changes PC-IOL Product Mix
The market for presbyopia-correcting intraocular lenses (PC-IOLs) has shown a dramatic shift toward trifocal lenses, judging from US surgeons’ early adoption rates of Alcon’s PanOptix lens in Q4-20...
Coronavirus Updates: ARVO Meeting, Biogen Cases, AAO Warning, Other News
Concerns about the coronavirus pandemic led the Association for Research in Vision and Ophthalmology (ARVO) to cancel its 2020 meeting, which had been set for May 1-7 in Baltimore. In a statement o...
Indian Ophthalmologists Vent Frustrations with Public Insurance Plan
Ophthalmologists at the All India Ophthalmological Society Congress (AIOC) voiced frustration with costs and reimbursement levels under the new health insurance program for the poor. India’s govern...
Mazzo Will Retire from Zeiss; He Says He’ll Remain Active in Ophthalmology
Jim Mazzo will retire from his position as president, ophthalmic devices, and head of the Ophthalmic Devices strategic business unit for Zeiss, effective May 1, the company announced March 9. Euan ...
Allergan Receives US FDA Approval for Durysta Bimatoprost Implant
The US FDA has approved Allergan’s Durysta (10 microgram bimatoprost implant) for intracameral administration, the company announced March 5. Durysta is the first intracameral, biodegradable sustai...
Novartis Continues to Review Adverse Events Related to Beovu Injections
Novartis continues to review a limited number of cases of severe vision loss, retinal artery occlusion, and/or vasculitis in patients treated with its retinal drug Beovu, the company announced Marc...
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Researchers are Studying Nanodiamonds for Antioxidant Delivery to Treat Cataracts
Scientists at Missouri S&T in Rolla, Missouri, are merging medicine and materials to study the use of nanodiamonds for antioxidant delivery to halt or delay cataracts and other degenerative eye dis...
Seven Vision Projects Make Top 100 for MacArthur Foundation’s New $100M Contest
Seven vision-related projects are among the top 100 finalists for the MacArthur Foundation’s second 100&Change global competition. The competition awards $100 million to a single proposed philanthr...
Kala Leads Latest Fundraising Efforts with $126.2 Million Public Offering
Kala Pharmaceuticals, of Watertown, Massachusetts, led recent fundraising efforts by ophthalmic companies. The company raised $126.2 million in an underwritten public offering of 16 million shares....
March 2020 Ophthalmic News Briefs
PDL BioPharma, parent of LENSAR, announced March 11 that it planned to dissolve itself by the end of 2020. The new timeline is much faster than the two- to three-year plan outlined in a presentatio...
DOJ Sues SpineFrontier for Surgeon Kickbacks
The US Department of Justice filed a complaint against SpineFrontier for alleged surgeon kickback payments between 2013 and 2018. SpineFrontier is accused of using a sham company, Impartial Medical...
Synopsys’ Simpleware AS Ortho Provides Image Segmentation
Synopsys, a publicly owned software company, announced March 11 that its Simpleware AS Ortho (automatic segmenter for orthopedics) software module is available. The software uses algorithms to quic...
NuVasive Attrax Putty Proves Non-Inferior to Autograft in Randomized Controlled Trial
NuVasive announced March 10 that study results for its Attrax microporous ceramic bone putty were published in the journal Spine. One hundred patients were selected to receive Attrax and autograft ...
Intellijoint Launches Knee Navigation
Intellijoint Surgical published the release of its Intellijoint KNEE navigation on March 3. This surgeon-controlled system provides positional information and cutting guides during total knee arthr...
Corin OMNIBotics Surpasses 25 Thousand Knee Replacements
Corin announced March 3 that its OMNIBotics robot-assisted surgery platform has been used in more than 25 thousand total knee arthroplasties (TKAs). The platform offers ligament tensioning, guide p...
OrthoPediatrics Signs Direct Sales Agreement in Italy
OrthoPediatrics reported March 3 that it signed a sales agreement with Medical 2011. Medical 2011 will sell OrthoPediatrics’ products directly to hospitals in Italy. Prior to this agreement, Medica...
Implanet Expands Sales in Germany
France-based Implanet announced March 3 that it is focused on increasing direct sales and commercial roll-out in Germany. The country-wide initiative will be led by Stephan Collardey at the firm’s ...
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COVID-19 Pandemic Creates Elective Surgery Barriers in Europe and Threatens US Market
The COVID-19 pandemic is encroaching on elective surgical procedures throughout Europe; almost 15 thousand cases are reported on the WHO COVID-19 Situation Reports and the Johns Hopkins’ COVID-19 T...
ARVO Cancels 2020 Meeting in Baltimore
The Association for Research in Vision and Ophthalmology has canceled its 2020 meeting, which had been set for May 1-7 in Baltimore. In a statement on its website, ARVO said that guidance from the ...
Mazzo Will Retire from Zeiss but Will Remain Active in Ophthalmology
Jim Mazzo will retire from his position as president, ophthalmic devices, and head of the Ophthalmic Devices strategic business unit for Zeiss, effective May 1, the company announced March 9. Euan ...
LENSAR Parent PDL Moves Up Timeline for Dissolving to End of 2020
PDL BioPharma, parent of LENSAR, announced March 11 that it planned to dissolve by the end of 2020. The new timeline, laid out in PDL’s earnings report, is much faster than the two- to three-year p...
82 of 108 Coronavirus Cases in Massachusetts Linked to Biogen Meeting
Updated March 13 with the latest totals from Massachusetts. As the COVID-19 coronavirus spread in Massachusetts, state health officials said the lion’s share of cases had a direct connection to a m...
Second Ophthalmologist Dies at Hard-Hit Chinese Hospital
Ophthalmologist Zhu Heping died March 9 of COVID-19 at the Central Hospital of Wuhan, the Chinese news website Caixin reported. Zhu was the fourth doctor at the hospital to succumb to the coronavir...
Avellino Labs Announces Availability of Coronavirus Test
Avellino Labs, of Menlo Park, California, announced March 9 that its newcoronavirus diagnostic test was available in the US. The test is designed to identify two genetic factors tied to expression ...
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Eyevance Launches Tobradex ST in the US for Inflammatory Eye Conditions
Eyevance announced March 2 the US launch of Tobradex ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05%. The Fort Worth, Texas, company acquired the product from Novartis in late 2019. ...
EyePoint Reports 2019 Revenue of $20.4 Million
EyePoint Pharmaceuticals reported March 5 that its full year 2019 revenue totaled $20.4 million, compared with $4.6 million in 2018. Net product revenue was $16.8 million, with $12.0 million for Yu...
ImprimisRx Announces Supply Agreement with iOR Partners
ImprimisRx, an ophthalmic-focused pharmaceutical compounding business, announced March 9 that it had agreed to a product supply agreement with iOR Partners. iOR Partners, of Kansas City, is focused...
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AbbVie, Allergan Sell GI Candidate, Clear EU Merger Hurdle; US Review Ongoing
AbbVie Inc. and Allergan PLC cleared the final European regulatory hurdle March 3 for their $63 billion union, but US review looks likely to push the closing to at least April. The companies said t...
SI Fusion Incentives Increase, But Doubts Remain
2020 is shaping up to be a big year for sacroiliac (SI) joint fusion. Effective Jan. 1, CMS increased the procedure’s relative value units (RVUs), which dictates physician reimbursement. CMS increa...
Demand for Knee Replacement Grows Worldwide
Chronic knee pain plagues about 226 million people worldwide, including 14 percent of those over the age of 45 and 40 percent of those over 65. For the majority, osteoarthritis (OA) pain is bothers...
Knee Surgeons Share Procedure Volumes and Patient Selection Criteria
Market Scope surveys spine, knee, hip, and shoulder surgeons every quarter about procedure volumes, preferred treatments, adoption of new technology, surgical techniques, and plans. Our Q3-2019 kne...
Orthopedic Market Revenue Up 2.3 Percent in Q4-2019
Orthopedic industry revenue increased 2.3 percent in Q4-2019 compared with Q4-2018 with single-digit growth in all segments except neuromodulation. Compared with the same quarter last year, knee re...
Orthopedic Deals Surpass $1.1 Billion From Jan. 22 Through Feb. 26
The amount raised through major orthopedic deals in the last month was $1.12 billion, plus undisclosed transaction totals. The largest amount was raised by Integra LifeSciences, which priced over $...
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Orlando AAOS Meeting Scheduled to Begin March 24
The annual meeting for the American Academy of Orthopaedic Surgeons (AAOS) is scheduled for March 24-28 at the Orange County Convention Center in Orlando, Florida. Last year’s meeting in Las Vegas ...
COVID-19 Spreads, Increasing Orthopedic Market Impact Potential
News of the COVID-19 (coronavirus) epidemic has dominated the media in recent weeks, spreading concerns about a pandemic, dragging down stock market indexes, and changing behaviors. The World Healt...
Orthopedic US FDA 510(k) Clearances
During the past month, the FDA cleared 37 orthopedic medical devices through the 510(k) pathway. Fourteen of the devices are indicated for spine surgery, three are biologics and two are for surgica...
Conformis’ Knee Gets 5A Rating From UK Panel
Announced Feb. 19, Conformis received a 5A rating from the Orthopaedic Data Evaluation Panel (ODEP) for its iTotal CR knee replacement system. ODEP is a UK organization of surgeons and experts that...
Graftys Partners With OrthoPediatrics to Distribute Bone Cement in the US
On Feb. 19, Graftys, the Belgian manufacturer of QuickSet resorbable bone cement, announced an agreement with OrthoPediatrics to distribute the cement in the US. The calcium-phosphate-based cement ...
Study Finds RTI Surgical’s SImmetry Has 98 Percent Fusion Rate
RTI Surgical announced Feb. 26 that 24-month follow-up results from the EVoluSIon study are available for 50 patients who received sacroiliac (SI) joint fusion with the SImmetry device. Ninety-eigh...
Bundled Payment Plans May Not Lead to Cherry Picking, According to Study
A major argument against bundled payment plans—which pay doctors and facilities a fixed amount per case regardless of the complexity or follow-ups needed within 90 days—is the fear that high-risk p...
Artebone Yields Clinical Results Similar to Autograft
Clinical results were announced Feb. 19 from a study by Bioactive Bone Substitutes, the Finnish company that produces Artebone. Artebone is a synthetic bone substitute enhanced with bone protein ex...
Allergan Receives US FDA Approval for Durysta Bimatoprost Implant
The US FDA has approved Allergan’s Durysta (10 microgram bimatoprost implant) for intracameral administration, the company announced March 5. Durysta is the first intracameral, biodegradable sustai...
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Iridex Launches Next-Generation MicroPulse P3 Device for Glaucoma
Iridex, of Mountain View, California, has released the second generation of its MicroPulse P3 device, redesigned to deliver greater stability, visualization, coupling, and fit, the company said. Th...
Oculis Appoints Marcia de Souza Lima, MD, as Chief Medical Officer
Oculis, of Lausanne, Switzerland, announced March 3 that it had appointed Marcia de Souza Lima, MD, as chief medical officer. De Souza Lima, an ophthalmologist by training, joins Oculis with more t...
Researchers are Studying Nanodiamonds for Antioxidant Delivery to Treat Cataracts
Scientists at Missouri S&T in Rolla, Missouri, are merging medicine and materials to study the use of nanodiamonds for antioxidant delivery to halt or delay cataracts and other degenerative eye dis...
ReNeuron Cites Positive Results, Looks to Expand its Retinal Stem Cell Trial
ReNeuron Group plans to expand the ongoing Phase I/IIa clinical trial of its human retinal progenitor cell (hRPC) stem cell therapy candidate in retinitis pigmentosa (RP) in the wake of positive lo...
Supreme Court Agrees to Third Review of Affordable Care Act
The US Supreme Court agreed March 2 to consider the fate of the Affordable Care Act for a third time. The Supreme Court’s next term begins in October, and a decision likely would come after the 202...
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Cambium Biologic Candidate Gains Orphan Status for Ocular Graft-Versus-Host Disease
Cambium Medical Technologies announced Feb. 26 that its topical biologic eye drop candidate gained orphan drug designation from the US FDA for the treatment of ocular graft-versus-host disease. The...
HumanOptics Gains CE Marking for Trifocal Lens
Germany-based HumanOptics announced Feb. 18 that its TRIVA-aA trifocal lens gained CE marking. The company described the lens as incorporating high-precision sub-nano resolution technology. The mil...
Gemini, Singapore Eye Explore New Targets for PCV, AMD
Gemini Therapeutics and the Singapore Eye Research Institute (SERI) have teamed up to explore the link between genetic and potential biomarkers in patients diagnosed with polypoidal choroidal vascu...
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Alimera Sciences Reports 2019 Revenue of $53.9 Million
Alimera Sciences reported Feb. 26 that its full-year 2019 net revenue totaled $53.9 million, an increase of 16 percent over 2018. Q4-2019 net revenue was $17.3 million, an increase of 15 percent ov...
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Glaukos Records 2019 Net Sales of $237 Million, an Increase of 31 Percent
Glaukos reported Feb. 27 that its full-year 2019 net sales were to $237.0 million, a gain of 31 percent over 2018 net sales of $181.3 million. Q4-2019 net sales were $65.8 million, an increase of 2...
STAAR Reports Full-Year 2019 Net Sales of $150.2 Million
STAAR Surgical reported Feb. 26 that its full-year 2019 net sales totaled $150.2 million, an increase of 21 percent over 2018. Q4-2019 net sales were $38.9 million, up 25 percent over Q4-2018. The ...
New Cataract Atlas Identifies Location of Premium IOLs and High Volume Surgeons
The metro areas of New York, Los Angeles, Dallas, and Chicago account for 14 percent of the population over 60 in the US. However, on a per capita share basis, most of the metro areas in Florida st...
AAO Warns Ophthalmologists of Link Between Coronavirus, Conjunctivitis
Anecdotal reports suggest the COVID-19 virus can cause conjunctivitis and possibly be transmitted by airborne particles coming in contact with the conjunctiva, according to a warning posted online ...
Novartis Reviewing Reports of Vasculitis Related to Beovu Injections
Novartis confirmed to Market Scope on Feb. 26 that the drugmaker is reviewing reports of cases of vasculitis in patients treated with the company’s new retinal drug, Beovu. The review was prompted ...
Gene Therapy Pioneer Katherine High to Leave Spark After $4.3 Billion Roche Deal
Spark Therapeutics co-founder Katherine High, MD, is leaving the gene therapy company, the Philadelphia Business Journal reported. High’s departure comes about two months after Spark was acquired b...
Seven Vision Projects Make Top 100 for MacArthur Foundation’s New $100 Million Contest
Seven vision-related projects are among the top 100 finalists for the MacArthur Foundation’s second 100&Change global competition. The competition awards $100 million to a single proposed philanthr...
Aerie Reports 2019 Net Revenue of $69.9 Million
Aerie Pharmaceuticals reported Feb. 20 that 2019 net revenue totaled $69.9 million, exceeding the upper end of guidance of $61 million to $66 million. Its Q4-2019 net revenue was $24.7 million. The...
Alcon Reports 2019 Net Sales of $7.36 Billion
Alcon reported Feb. 25 that itsfull year 2019 net sales totaled $7.36 billion, an increase of 3 percent (+5 percent cc) over net sales of $7.15 billion in 2018. Full-year surgical net sales of impl...
Diagnos Announces New Private Placement to Raise $1.32 Million
Canadian artificial-intelligence company Diagnos announced Feb. 24 that it planned to raise gross proceeds of US $1.32 million ($1.75 million in Canadian currency) through a non-brokered private pl...
EyePoint Announces Public Offering to Raise $21.75 Million
EyePoint Pharmaceuticals announced Feb. 21 the pricing of an underwritten public offering of 15 million shares of common stock at $1.45 per share, for gross proceeds $21.75 million. The Watertown, ...
Leo Lens Pharma Receives Patent for Drug-Eluting Lens in Myopia
Leo Lens Pharma, of San Diego, announced Feb. 19 that it had received a patent for the use of its MediPrint process to manufacture a contact lens capable of providing enhanced myopia management. Th...
LumiThera to Study its Valeda Photobiomodulation System for DR
LumiThera,of Poulsbo, Washington, announced Feb. 18 that it had teamed with the University of Wisconsin-Milwaukee to study its photobiomodulation (PBM) platform in diabetic retinopathy (DR). Janis ...
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Oculis Announces Positive OCS-01 Phase II Data in DME
Oculis reported on Feb. 10 positive data from a Phase II study of OCS-01, its novel eye drop formulation of dexamethasone, in development for the treatment of diabetic macular edema (DME). OCS-01 u...
Palatin Enrolls First Patient in Dry Eye Phase II Trial with PL9643
Palatin Technologies has enrolled the first patient in a Phase II clinical trial of topical PL-9643, a melanocortin 1/5 receptor (MC1/5r) agonist, for the treatment of dry eye disease, the company ...
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Ribomic Injects First Patient in Phase II Trial of Wet AMD Candidate
Tokyo-based Ribomic announced Feb. 19 that the first patient had been injected in its Phase II of trial RBM-007 for the treatment of wet age-related macular degeneration (AMD) in the US. The first ...
EyePoint Licenses Tyrosine Kinase Inhibitor from Equinox for Wet AMD, DR, RVO
EyePoint Pharmaceuticals announced Feb. 3 that it had signed an exclusive license agreement with Equinox Science to develop Equinox’ vorolanib, a tyrosine kinase inhibitor, for the treatment of wet...
Stryker Announces New Date for Wright Medical Acquisition
Stryker B.V., a wholly owned subsidiary of Stryker, said Feb. 26 that the period of its cash offer for all outstanding shares of Wright Medical stock has been extended to April 30.
India Will Regulate Orthopedic Implants as Drugs Starting in April
Announced Feb. 12, the Indian government will regulate all medical devices, including orthopedic implants, as drugs under the Drugs and Cosmetics Act. The change will begin in April 2020; low- to m...
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