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Adverum Doses First Patient in Second Cohort After FDA Lifts Hold on Wet AMD Trial
Adverum Biotechnologies announced June 10 that the first patient was dosed in the second cohort of its Phase I clinical trial for ADVM-022 for the treatment of wet age-related macular degeneration ...
Acucela Receives Orphan Designation from the EMA for Emixustat for Stargardt Disease
Seattle-based Acucela, a subsidiary of Kubota Pharmaceutical Holdings in Japan, announced June 9 that the European Medicines Agency (EMA) granted orphan designation to Acucela’s leading drug candid...
Glaucoma Device Company Changes Name from Camras to Alievio
North Carolina-based Camras Vision announced June 12 that it had changed its name to Alievio as part of a rebranding effort for its glaucoma treatment device candidate. The rebranding includes a ne...
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Orthopedic US FDA 510(k) Clearances
Forty-five orthopedic medical devices received FDA clearance between April 25 and May 24. Twenty-two of the devices were spine specific. Twelve of the spine devices are for fixation: six plates, fi...
Monthly Deals
Between April 15 and May 15, eight noteworthy deals took place; there were two financing rounds, one sublicense agreement, four acquisitions, and one merger agreement. ApiFix and Catalyst OrthoScie...
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Orthopedic Revenue Up Slightly in Q1-2019
Orthopedic industry revenue in Q1-2019 was roughly equivalent to the same quarter last year. However, there were significant differences at both the segment level (-0.8 percent to +1.3 percent) and...
Company Spotlight: ZipLine Medical
ZipLine Medical produces a non-invasive alternative to sutures and staples for incisions and lacerations. Its flagship product, the Zip Surgical Skin Closure, comprises two strips of pressure-sensi...
Manufacturers Tout Cost Savings and Short-Term Benefits of ADR
Patients desire alternatives to fusion in the cervical spine to preserve range of motion. Artificial discs pose one solution. Manufacturers continue to market innovative disc designs in an attempt ...
Judge Rules in Favor of US FDA in Bid to Crack Down on Stem Cell Clinics
A federal judge ruled in favor of the US FDA on June 3 in a lawsuit against a Florida-based stem cell company whose treatments have blinded at least three patients, The Washington Post reported. Ju...
Ophthalmologists Urge FDA to Create Exemption for Compounding of Office Stock
Three eye surgeons asked FDA officials May 21 to create an exemption that would allow ophthalmologists to obtain certain compounded drugs for office stock from state-regulated pharmacies, an action...
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Patricia Bath, Pioneer and Holder of Patents in Laser Cataract Surgery, Dies at 76
Patricia Bath, MD, a pioneering ophthalmologist who held five US patents in cataract surgery, died May 30 in San Francisco, The Associated Press reported. She was 76. Dr. Bath took special interest...
Oxurion Announces Phase I/II Trial Results of THR-317 Candidate for DME
Oxurion, the Belgian company formerly known as ThromboGenics, said June 6 that results from a Phase I/II study of its PlGF candidate THR-317 for the treatment of diabetic macular edema (DME) had be...
Demand for Knee Replacement Grows 5 Percent Worldwide
Approximately 40 percent of the global population over age 55 experiences chronic knee pain. Of those, 50.8 million suffer from disabling pain, and about 2.6 million turn to knee replacement surger...
Outlook Signs Manufacturing Deal with Fujifilm Diosynth to Produce Wet AMD Candidate
Outlook Therapeutics announced June 3 that it has signed an agreement with Fujifilm Diosynth Biotechnologies (FDB) to produce ONS-5010, its proprietary ophthalmic formulation of bevacizumab intende...
Eyenovia Enrolls First Patient in Phase III Study of MicroPine for Progressive Myopia
Eyenovia announced June 4 that it has initiated its MicroPine Phase III program with the first patient enrolled in its CHAPERONE study. The US-based study will enroll more than 400 children between...
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Alimera Says Three-Year Trial Results Support Iluvien Launch in Europe for Posterior Uveitis
Alimera Sciences announced on June 6 the three-year follow-up data from the Phase III trial for its Iluvien 0.19 mg fluocinolone acetonide intravitreal implant for posterior uveitis. The Alpharetta...
Immunocore’s Study of Targeted Cancer Therapy for Uveal Melanoma Shows Promising Results
Treatment with tebentafusp induced an immunologically potent response in patients with advanced uveal and cutaneous melanoma, according to data presented June 3 by Immunocore at the 2019 American S...
BONESUPPORT Is Exclusive US Distributor of Cerament
BONESUPPORT announced May 22 that it will be the exclusive US distributor of Cerament, its synthetic bone graft substitute. The firm ended its distribution agreement with Zimmer Biomet in 2018 and ...
FDA Allows Periprosthetic Infection Test to Enter the Market
The US FDA approved the marketing of Synovasure’s Lateral Flow Test Kit, the firm announced May 23. This test is designed to detect periprosthetic joint infections in the synovial fluid of patients...
Globus Medical Publishes Pedicle Screw Placement Data for ExcelsiusGPS
Globus Medical announced May 23 that results of a retrospective pedicle screw placement study were published in the Journal of Robotic Surgery. Results from 100 robotic lumbosacral surgery cases we...
Glaucoma Patients May Be at Higher Risk of Crashes than those of Similar Age, Study Suggests
Researchers from Wills Eye Hospital in Philadelphia found that the rate of car accidents in patients with glaucoma was almost five times higher than expected for Pennsylvania drivers in the same ag...
Alimera Launches Direct-to-Patient Marketing Campaign for Iluvien
Alimera Sciences announced May 22 the launch of a direct-to-patient marketing campaign to educate patients diagnosed with diabetic macular edema (DME) and their caregivers about its sustained-relea...
Ocular Therapeutix Gets C-Code and Pass-Through Payment Status for Dextenza
Ocular Therapeutix announced May 29 that the Centers for Medicare and Medicaid Services (CMS) approved transitional pass-through payment status and established a new reimbursement code for Dextenza...
Regenxbio Completes Dosing in Phase I/IIa Trial of Gene Therapy for Wet AMD
Regenxbio, of Rockville, Md., announced May 30 that it had completed dosing across all five cohorts in its Phase I/IIa clinical trial of gene therapy RGX-314 for the treatment of wet age-related ma...
Biophytis Files Registration Statement for Proposed IPO in the US
Biophytis, of Paris, has filed SEC paperwork for a $15 million initial public offering under the symbols BPTS on the Nasdaq and ALBPS on Euronext Growth Paris. The company has a drug candidate for ...
Quantel Medical Gains CE Marking for its LacryStim Device for Dry Eye
Quantel Medical announced May 23 that it has obtained CE marking for the LacryStim IPL, its new device for treating dry eye. Quantel is a subsidiary of Lumibird, which provides laser technology for...
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New Grant at UMass Amherst Will Fund Research into Stargardt Disease
Paul Manning, an entrepreneur with 30 years of experience in health care, and his wife, Diane, have committed $1 million through their family foundation to establish the Manning Innovation Program ...
OptiKira Gets $1.6 Million Grant for Work on Retinitis Pigmentosa
OptiKira announced May 31 that it was awarded a Phase II Small Business Innovation Research grant to support continued development of a therapy that has the potential to preserve vision in patients...
TearClear Appoints Srini Venkatesh as Chief Scientific and Innovation Officer
TearClear, a specialty pharmaceutical company focused on developing preservative-free topical ophthalmic drugs, announced May 29 the appointment of Srini Venkatesh, PhD, as chief scientific and inn...
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Record Crowd Flocks to ARVO Meeting in Vancouver
The 2019 meeting of the Association for Research in Vision and Ophthalmology (ARVO) served up controversy, prognostications, and basic science to the largest ARVO audience ever, estimated at 15 tho...
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ASCRS Meeting’s Refractive Program Covers Milestones, Pipeline Technology, Negative Press
The Refractive Day program at the 2019 meeting of the American Society of Cataract and Refractive Surgery (ASCRS) was filled with discussions of visual outcomes with both refractive and cataract pr...
Premium IOLs Dominate Cataract Sessions at 2019 ASCRS Meeting
Much of the focus of cataract sessions at the 2019 meeting of the American Society of Cataract and Refractive Surgery (ASCRS) was on premium IOLs. Several European surgeons described their clinical...
OIS Panelists Discuss Top Factors for Investing in Innovative Technology
A panel of experts at the spring 2019 Ophthalmology Innovation Summit discussed the most important factors in investing in innovative technologies. Panel members said to choose opportunities that a...
Novartis to Acquire Xiidra From Takeda for up to $5.3 Billion
Novartis announced May 9 that it will acquire the dry eye drug Xiidra from Japanese drug maker Takeda. Switzerland-based Novartis will pay $3.4 billion up front, plus up to $1.9 billion in mileston...
Glaukos to Market Santen’s MicroShunt in the US
Glaukos will become the exclusive US distributor of Santen’s MicroShunt, if it gains FDA approval, under a multiyear agreement announced April 26. The MicroShunt is a minimally invasive, ab externo...
Presbia Lays off Most Employees, Looks for Funding for Microlens Candidate
Presbia has laid off all but three employees at its Irvine, California, office in light of new FDA requirements for its pending application for the Flexivue Microlens. The company reported in an SE...
Emerging Companies Pursuing Ophthalmic Indications, May 2019
Market Scope is tracking companies that have announced new candidates to treat eye disease. Emerging Companies in the Ophthalmic Industry Company Location About 2C Tech Irvine, California The compa...
US FDA Expands Labeling for Regeneron’s Eylea to All Stages of DR
Regeneron’s Eylea has gained US approval for the added indication of all stages of diabetic retinopathy (DR) the company announced May 13. The VEGF inhibitor previously was labeled for diabetic mac...
Novel Approaches to Cataract Surgery are Challenging Phaco, but Success Could Come Down to Cost
Source: Market Scope Ultrasonic phacoemulsification (USP) has been the dominant method of cataract surgery globally over the past half century, but novel alternative approaches are attempting to im...
Applied Therapeutics Leads Latest Fundraising Efforts with $40 Million in Financing
Applied Therapeutics led recent fundraising efforts by ophthalmic companies, raising $40 million in its initial public offering. Other firms with financing deals included Livionex Pharma with $4 mi...
Surgeons Rate Low Incidence of Visual Disturbances as Top IOL Feature
US cataract surgeons continue to seek new designs and improvements in intraocular lenses to maximize patient outcomes, even with the variety of multifocal, toric, extended depth of focus, and presb...
Surgical Specialties Launches New Division to Focus on Global Growth in Ophthalmology
Surgical Specialties Corp. (SSC) announced May 20 the launch of Caliber Ophthalmics, a new business division. Caliber combines SSC's Sharpoint brand with its two recent ophthalmic acquisitions,...
Second Sight to Focus on Orion, Suspend Production of Argus II
Second Sight Medical Products announced May 15 that it plans to accelerate development and commercialization of its Orion Visual Cortical Prosthesis System, a device implanted in the brain, and sus...
Market Scope Weekly Ophthalmic Surgeon Polls for May 2019
Market Scope Weekly Poll for May 13-19, 2019
May 2019 Ophthalmic News Briefs
Aerie Launches Rocklatan for Glaucoma, Readies Retinal Candidate for First-in-Human Study Aerie Pharmaceuticals announced May 1 that it has launched Rocklatan in the US for patients with glaucoma. ...
HSS Study Shows AI May Predict Joint Replacement Outcomes
The Hospital for Special Surgery announced results of a study on May 16, showing that predictive AI algorithms can help identify successful THA or TKA patients. Results were published in the June 2...
Medtronic Leaves Bundled Joint Replacement Business
Medtronic entered the bundled joint replacement arena when it purchased Responsive Orthopedics in 2016. The company announced May 9 that it plans to auction Responsive Orthopedics and focus on its ...
Surgical Specialties Launches New Division to Focus on Global Growth
Surgical Specialties Corp. (SSC) announced on May 20 the launch of Caliber Ophthalmics, a new business division. Caliber combines SSC's Sharpoint brand with its two recent ophthalmic acquisitio...
USC Paid Ousted Med School Dean Puliafito Nearly $1 Million
The University of Southern California paid ophthalmologist Carmen Puliafito, MD, its former medical school dean, nearly $1 million in severance along with a bonus, the LA Times reported. Puliafito,...
Santhera Licenses LHON Treatment Raxone to Chiesi Group Outside US for up to $104 Million
Swiss company Santhera Pharmaceuticals has entered into an exclusive license agreement with Chiesi Farmaceutici for its Raxone treatment for Leber's hereditary optic neuropathy (LHON). The deal...
New Wize CEO Turns Attention to Ophthalmic Gene Therapy
Israel-based Wize Pharma announced May 21 that it had named a new CEO and chairman and is actively evaluating an acquisition candidate in the ophthalmic gene therapy space. The clinical-stage bioph...
Iridex Announces David Bruce as New President, CEO
Iridex, a provider of laser technology for glaucoma and retinal disease, announced the appointment of David Bruce as president and chief executive officer, effective May 21. Bruce has been a member...
FDA Lifts Clinical Hold on Adverum’s Phase I Trial of Gene Therapy Candidate in Wet AMD
Adverum Biotechnologies reported May 16 that the US FDA had lifted the clinical hold on the company’s Phase I trial of its gene therapy candidate for wet AMD. ADVM-022 is a single-administration ge...
Catalyst OrthoScience Publishes Study Results for Total Shoulder System
Catalyst OrthoScience announced May 9 that results of a study on its Catalyst CSR total shoulder system were published in the Journal of Shoulder and Elbow Arthroplasty. The CSR system is unique be...
Novel Approaches to Cataract Surgery are Challenging Phaco; Cost May Determine Their Success
Ultrasonic phacoemulsification (USP) has been the dominant method of cataract surgery globally over the past half century, but novel alternative approaches are attempting to improve or replace it. ...
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Second Sight to Focus on Orion, Suspend Production of Argus II
Second Sight Medical Products announced May 15 that it plans to accelerate development and commercialization of its Orion Visual Cortical Prosthesis System, a device implanted in the brain, and sus...
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Bausch + Lomb’s Q1-2019 Revenues Increase 1 Percent to $1.12 billion
Bausch + Lomb posted revenues of $1.12 billion in Q1-2019, a 1 percent increase (+7 percent in constant currency) over Q1-2018 revenues of $1.10 billion. The New Jersey-based eye care segment of Ba...
US FDA Expands Labeling for Regeneron’s Eylea to All Stages of DR
Regeneron’s Eylea has gained US approval for the added indication of all stages of diabetic retinopathy, the company announced May 13. The VEGF inhibitor previously was labeled for diabetic retinop...
Harrow Health’s Q1-2019 Revenues Increase 39 Percent
Harrow Health reported May 9 that its Q1-2019 revenues totaled $12.3 million, a 39 percent increase over Q1-2018 revenues of $8.9 million. The San Diego drug developer and compounder attributed the...
BVI Appoints Shervin Korangy as President, CEO
Ophthalmic device maker BVI Medical announced May 16 that it has appointed Shervin Korangy as president and chief executive officer. Korangy replaces Dana Mead Jr., who will continue to serve as vi...
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BioTime Receives New $2.5 Million Grant to Advance OpRegen
BioTime announced May 10 that it has received a $2.5 million grant from the Israel Innovation Authority to continue development of OpRegen. OpRegen is a retinal pigment epithelium transplant therap...
Livionex Raises $4M in Series A to Advance Candidates for Cataracts, Other Diseases
Livionex Pharma announced May 13 that is raised $4 million in a Series A round to advance its treatments for cataracts, gum disease, and herpes simplex virus. The San Francisco company said it is s...
Kala Reports Q1-2019 Revenues of $1.4 Million for Inveltys
Kala Pharmaceuticals reported May 9 that its Q1-2019 revenues for Inveltys totaled $1.4 million. Inveltys was launched in January 2019. Inveltys is a combination of Kala’s AMPPLIFY drug delivery te...
Applied Therapeutics Raises $40M in IPO; Pipeline Includes Topical Candidate for DR
Applied Therapeutics raised $40 million in its initial public offering and began trading May 14 on the Nasdaq Global Market under the symbol APLT. The New York company priced 4 million shares at $1...
CollPlant Trial Results Show Receptor-Optimized BMP-2 Composite Is Preferable to Standard of Care
CollPlant reported April 24 that results from its study of receptor-optimized BMP-2/6/Activin in a ceramic and rhCollagen matrix were published in Science Translational Medicine. Bioventus created ...
Relievant Releases 24-Month Results for SMART Trial
Relievant Medsystems announced April 24 that it has published 24-month results for its SMART Trial in the International Journal of Spine Surgery. Of 128 patients in the trial, 106 completed the 24-...
US FDA Approves Naloxone Nasal Spray
According to an April 19 press release, the FDA approved a generic naloxone nasal spray. Naloxone is commonly known by the brand name Narcan; it is used to combat narcotic overdoses. The generic sp...
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Novartis to Acquire Xiidra From Takeda for up to $5.3 Billion
Novartis announced May 9 that it will acquire the dry eye drug Xiidra from Japanese drug maker Takeda. Switzerland-based Novartis will pay $3.4 billion up front, plus up to $1.9 billion in mileston...
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Orthopedic US 510(k) Clearances
Stimwave received FDA clearance at the end of March for an update to its Freedom spinal cord stimulator system to include pulse widths of 30 µs to 1000 µs and high frequency stimulation in the rang...
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Heritability Study of Knee OA
A recent study examined the heritability of knee osteoarthritis (OA) among twins. OA is a degenerative joint disease, and it is a primary inciting factor for joint replacement surgery. Knee OA has ...
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2019 APSS Annual Meeting
Over 600 attendees convened at the Songdo Convensia in Incheon, South Korea, for the joint meeting of the Asia Pacific Spine Society (APSS) and Asia Pacific Pediatric Orthopaedic Society (APPOS). T...
Jury Trial Begins in Allergan’s Suit of Imprimis Pharmaceuticals over Compounding
A California jury will decide whether Allergan has suffered monetary harm from Imprimis Pharmaceuticals’ compounding of ophthalmic drugs. US District Judge David O. Carter is overseeing the trial, ...
FDA to End Alternative Summary Reporting Program for Device-Related Injuries
The US FDA announced May 2 that it is ending the alternative summary reporting program for all medical devices. The program allowed device makers to report adverse events to a database inaccessible...
Monthly Orthopedic Fundraising
The overall value of the orthopedic market increases when companies obtain money from outside sources such as public market fundraising or grants. The goal of this feature is to track these fundrai...
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Company Spotlight: Reflexion Health
Reflexion Health’s VERA (Virtual Exercise Rehabilitation Assistant) proposes a solution for common frustrations with the health care system. The company began nearly six years ago from a concept de...
The Race for a Robotics Ecosystem
Orthopedic manufacturers are racing to develop surgical robots for total joint arthroplasty (TJA) that promise improved outcomes, faster surgery, and fewer complications. Market opportunity for sur...
EyePoint Reports Q1-2019 Net Revenues for Yutiq, Dexycu
EyePoint Pharmaceuticals reported May 8 that its Q1-2019 net revenues totaled $2.0 million compared with $928 thousand in Q1-2018. The Watertown, Massachusetts company launched Yutiq (chronic non-i...
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Allergan Reports Q1-2019 Total Revenues of $3.6 Billion
Allergan reported May 7 that its Q1-2019 net revenues totaled $3.6 billion, a 2.0 percent decrease from $3.7 billion in Q1-2018. Restasis’ net revenues globally were $242.1 million, a decrease of 1...
US to Require Drug Makers to Publish List Prices in TV Ads
US health officials announced May 8 that they will require drug makers to include the list price of prescription drugs in TV ads if the price is $35 or more. The rule goes into effect in July 2019....
RP Subjects Treated with ReNeuron’s Stem Cell Therapy Candidate Improve 23 Letters
ReNeuron announced April 26 that the first three patients in a Phase I/IIa clinical trial of its stem cell therapy candidate for advanced retinitis pigmentosa (RP) showed meaningful improvement in ...
Aerie Launches Rocklatan for Glaucoma, Readies Retinal Candidate for Study
Aerie Pharmaceuticals announced May 1 that it has launched Rocklatan in the US for patients with glaucoma. The topical eye drop combines latanoprost, a prostaglandin analog, and netarsudil, the act...
Atia Vision Closes $20 Million Series D Financing
Atia Vision announced May 2 that it has closed a $20 million Series D preferred stock financing. The company is developing a modular accommodating intraocular lens and plans to use the funding to a...
Pixium Vision names Lloyd Diamond as CEO
Pixium Vision announced May 2 that it has named Lloyd Diamond as its new chief executive officer, effective May 13. The Paris-based company is developing the PRIMA subretinal implant, a wireless ph...
Brainlab Announces Class I Recall of Navigation Software
Brainlab announced April 16 that it recalled its Spine & Trauma 3D Navigation 1.0 software. The software was manufactured and distributed from May 2018 through Feb. 2019; approximately 60 US device...
Bioretec Acquires BRI.Tech
Finnish Bioretec announced April 16 that it has acquired Austria-based BRI.Tech. BRI.Tech manufactures a patented biocompatible and bioresorbable metal material, which Bioretech plans to incorporat...
InVivo Therapeutics Publishes 12-Month Results of INSPIRE Study
InVivo Therapeutics Holdings Corp. announced April 17 that 12-month results from its INSPIRE study of its neuro-spinal scaffold were presented at the 2019 AANS meeting. The single-arm study tracked...
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Presbia Lays off Most Employees, Looks for Funding for Microlens Candidate
Presbia has laid off all but three employees at its Irvine, California, office in light of new FDA requirements for its pending application for the Flexivue Microlens. The company reported in an SE...
Glaukos to Market Santen’s MicroShunt in the US
Glaukos will become the exclusive US distributor of Santen’s MicroShunt, if it gains FDA approval, under a multiyear agreement announced April 26. The MicroShunt is a minimally invasive, ab externo...
Alcon Looks to Regain Fast Growth, Healthy Profits as Standalone Firm
Alcon faces two challenges following its spinoff from Novartis: returning to its former status of faster-than-market growth and delivering healthy profits. Novartis completed its planned spin-off o...
APAO Congress Looks at Pluses, Minuses of New Technology
Gene therapy, artificial intelligence, corneal endothelial disease, and refractive intraocular lenses (IOLs) were key themes at a major ophthalmic meeting in March in Bangkok. The 34th Asia-Pacific...
2C Tech Begins Clinical Program to Study Quantum Dots in Retinal Disease
2C Tech of Irvine, California, announced April 23 that it has begun a US clinical program to study the use of quantum dots in patients with retinal disease, particularly retinitis pigmentosa. Quant...
Novartis’ Q1-2019 Net Sales Increase 2 Percent to $11.11B; Alcon’s Net Sales Flat
Novartis’ net sales in Q1-2019 totaled $11.11 billion, an increase of 2 percent (+7 percent in constant currency) over Q1-2018, the Swiss company reported April 24. The total excludes revenues for ...
New GenEye Database to Boost Research of Inherited Eye Diseases Worldwide
A global database of inherited eye diseases is set for a launch in May by the Global Eye Genetics Consortium (GEGC). The database is called GenEye. It includes genotype-phenotype matches for 36 inh...
European Parliament Loosens Drug Patent Regulations for EU-Made Generics, Biosimilars
The European Parliament overwhelmingly approved a proposal April 17 to allow EU biosimilar and generic drug developers to manufacture copies of some patent-protected products. The regulation applie...
NASA’s Twins Study Indicates Multiple Spaceflights Compound Vision Problems
Some vision problems that occur in long-term spaceflight may persist from a previous mission and worsen in a subsequent mission, according to NASA’s Twins Study. The space agency released the resul...
German Company Retina Implant AG Shuts Down
Retina Implant AG shareholders decided to dissolve the company March 19, 2019, at a general meeting. The German company announced the decision on its website a few days later. Founded in 2003, Reti...
PC-IOLs, SMILE Procedures are Prominent on Agenda of ASCRS Meeting
Surgeon interest in presbyopia-correcting IOLs (PC-IOLs) and SMILE procedures remains high, based on the agenda of this year’s meeting of the American Society of Cataract and Refractive Surgery (AS...
NGM Leads Latest Fundraising Efforts with $176.5 Million in Financing
NGM Biopharmaceuticals led recent fundraising efforts by ophthalmic companies, raising $176.5 million in its initial public offering and a private placement with Merck. Other firms with financing d...
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