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Company Spotlight: JLABS
January 2012 marked the launch of Johnson & Johnson Innovation’s JLABS, resource hubs for start-up pharmaceutical, medical device, consumer, and digital health companies, and a pipeline of new idea...
Dallas Hosts Over 3,500 for AAHKS
Each year, the American Association of Hip and Knee Surgeons has its annual conference at the Hilton Anatole in Dallas, Texas. The 2018 conference, held from Nov. 1-4, hosted roughly 3,500 attendee...
Shareholders Approve Takeda’s $62 Billion Acquisition of Shire
Shareholders voted Dec. 5 to approve Takeda’s proposed $62 billion acquisition of Shire. Eighty-eight percent of Takeda’s shareholders voted in favor of the acquisition. More than 99 percent of Shi...
US FDA to Modernize 510(k), De Novo Review Processes for Medical Devices
The US FDA plans to modernize the 510(k) and De Novo pathways for reviewing new medical devices. The 510(k) pathway, established in 1976, compares new technology with predicate, or existing, device...
US FDA Approves Ocular Therapeutix’ Dextenza for Post-Surgery Ocular Pain
The US FDA has cleared Ocular Therapeutix’ Dextenza 4 mg for intracanalicular use for the treatment of ocular pain following ophthalmic surgery, the company announced Dec. 3. Dextenza is a corticos...
Spark Pioneers Win $1 Million Sanford Lorraine Cross Award
Two women whose work contributed to the creation of Spark Therapeutics’ Luxturna have been awarded the inaugural $1 million Sanford Lorraine Cross Award, Sanford Health announced Dec. 6. Jean Benne...
ProQR Announces IND Clearance, Trial for Usher Syndrome Type 2 Candidate
The US FDA has cleared ProQR Therapeutics’ Investigational New Drug (IND) application for QR-421a, the Netherlands-based company announced Dec. 4. QR-421a is a first-in-class investigational RNA-ba...
Plex to Advance Topical Candidate for Cataracts to In Vivo Animal Studies
Plex Pharmaceuticals announced Dec. 3 that it plans to advance CAP1160, a topical treatment candidate for cataract disease, to in vivo animal studies. San Diego-based Plex (formerly CalAsia Pharmac...
Leiters Awarded Service Agreement with Premier that Includes Compounded Avastin
Leiters announced Dec. 3 that it has been awarded a three-year service agreement with Premier, a health care improvement company, which includes providing compounded Avastin. Premier has an allianc...
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Bausch + Lomb Signs Deal with Modulight to Develop Photodynamic Laser to Pair with Visudyne
Bausch + Lomb and Modulight, a laser company, announced Dec. 4 that they have entered an exclusive agreement to develop a laser for use with Visudyne (verteporfin for injection) photodynamic therap...
Cerament Non-inferior to Autograft in Study
Bonesupport announced successful top-line data on Nov. 19 from its CERTiFy study, which compared Cerament BVF (bone void filler) to autologous iliac bone graft. The study included 137 patients with...
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FDA Accepts Editas’ IND Application to Study CRISPR-Based Candidate for LCA10
Editas Medicine announced Nov. 30 that the US FDA has accepted its IND application to study its CRISPR-based genome editing medicine in patients with Leber congenital amaurosis type 10 (LCA10). Edi...
Innovasis Partners With Stability Biologics
Utah-based Innovasis Inc. signed a private-label agreement with Stability Biologics LLC, the company announced Nov. 19. Innovasis is a research, development, and manufacturing company for spinal de...
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EU Court Rules in Favor of Italy’s Off-Label Use of Avastin in Wet AMD
The Court of Justice of the European Union ruled Nov. 21 that Italy’s national health system can reimburse ophthalmologists for the use of off-label Avastin (bevacizumab) to treat age-related macul...
NEI Scientists Combine Adaptive Optics and Angiography to See Retina in Greater Detail
Investigators at the National Eye Institute (NEI) have combined two imaging modalities—adaptive optics and angiography—to see live neurons, epithelial cells, and blood vessels deep in the retina, t...
Notal Vision’s Home OCT Gains FDA Breakthrough Status
Notal Vision announced Dec. 3 that the US FDA has granted its home-based optical coherence tomography (OCT) system breakthrough status. The Notal Home OCT is designed to use artificial intelligence...
MeiraGTx Signs Agreement with NIDCR for Gene Therapy for Sjögren’s Syndrome
MeiraGTx has signed an exclusive licensing agreement with the National Institute of Dental and Craniofacial Research (NIDCR) for the global rights to a gene therapy designed to treat Sjögren’s synd...
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Superion Indirect Decompression System Reduces Opioid Use
Vertiflex Inc., a California company, announced study results for its Superion Indirect Decompression System on Nov. 20. The results were published in the Journal of Pain Research. Superion prevent...
Novartis Announces EU Approval of Luxturna
The European Commission has approved Luxturna as a one-time gene therapy for patients with vision loss due to a genetic mutation in both copies of the RPE65 gene who have enough viable retinal cell...
AcuFocus Plans Trial for IC-8 After Receiving US FDA IDE Approval
AcuFocus has received US FDA approval for an investigational device exemption (IDE) to conduct a pivotal study of the company’s IC-8 small aperture intraocular lens (IOL) for patients with cataract...
Eylea’s Global Net Sales Increase 10.5 Percent in Q3-2018
Global net sales for Eylea (aflibercept) rose to $1.68 billion in Q3-2018, up 10.5 percent compared with Q3-2017, Regeneron reported Nov. 6. Eylea’s net sales in the US in Q3-2018 were $1.02 billio...
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Imprimis’ Q3-2018 Revenues Increase 66 Percent; Company Will Change Name to Harrow Health
Imprimis reported Nov. 13 that its Q3-2018 revenues totaled $10.7 million, a 66 percent increase over Q3-2017 revenues of $6.5 million. Ophthalmology revenues increased 81 percent year over year to...
Oxurion, Beta Therapeutics to Collaborate on Heparanase Inhibitors for Retinal Disease
Belgium-based Oxurion (formerly ThromboGenics) announced Nov. 5 that it will collaborate with Beta Therapeutics of Australia to develop new heparanase inhibitors for the treatment of retinal diseas...
Interface Plans Phase II Trial of Dexamethasone Implant in DME
Interface Biologics is preparing for a Phase II trial of its IBE-814 intravitreal (IVT) implant, a sustained-release, low-dose dexamethasone implant in development for the treatment of inflammatory...
Optos Agrees to European, Australian Distribution Deal with MacuLogix, LumiThera
Optos has agreed to an exclusive distribution agreement in Europe and Australia for MacuLogix and LumiThera products, the Scotland-based company announced Oct. 24. Optos said the deal allows it to ...
First Patient Dosed in Adverum’s Phase I Trial of ADVM-022 Gene Therapy for Wet AMD
Adverum Biotechnologies announced Nov. 19 that the first patient has been dosed in a Phase I trial evaluating ADVM-022 for wet age-related macular degeneration (AMD). ADVM-022 is a gene therapy des...
EyePoint, Ocumension Partner to Develop Durasert for Posterior Segment Uveitis in China
EyePoint Pharmaceuticals and Ocumension Therapeutics have entered an exclusive license agreement to develop and commercialize EyePoint’s Durasert drug delivery technology for chronic, non-infectiou...
Second Sight Reports 20 Argus II Implantations, $2.2 Million in Revenues in Q3-2018
Second Sight announced Nov. 7 that surgeons implanted 20 Argus II retinal prostheses in Q3-2018, resulting in revenues of $2.2 million, compared with 12 implantations and $1.6 million in Q3-2017. N...
Taiwan Liposome Company Raises $22 Million in IPO
The Taiwan Liposome Company (TLC ) raised $22 million in its initial public offering, the Taipei, Taiwan, drugmaker announced Nov. 21. TLC offered 3.75 million American depositary shares at $5.80. ...
Altus Acquires ChoiceSpine
Altus Capital Partners, a private equity firm based in Connecticut, announced its acquisition of ChoiceSpine LP on Nov. 20. ChoiceSpine is a designer, manufacturer, and marketer of spinal implants,...
Colfax Acquires DJO Global for $3.15B
Maryland-based Colfax Corporation announced its acquisition of privately owned DJO Global Inc. on Nov. 19. Colfax is paying $3.15 billion in cash for the acquisition, which is expected to close Q1-...
Statera Spine Becomes Subsidiary of Ortho Kinematics
Statera Spine Inc., based in Texas, is a privately held healthcare diagnostics company. It announced Nov. 19 that it has become a subsidiary company of Ortho Kinematics Inc. As such, Statera will u...
Aurora Spine Gains SI Joint Product Patent in US
Aurora Spine, based in California, announced Nov. 16 that it gained exclusive license to the US patent for “percutaneous sacroiliac joint implant and method for surgically inserting and securing th...
SpinalCyte Announces 12-Month Results for CybroCell
Texas-based SpinalCyte LLC announced 12-month results for its study of CybroCell in patients with degenerative disc disease (DDD) on Nov. 14. CybroCell is a universal donor product made of modified...
US FDA Accepts IND for Eyenovia’s MicroStat
The US FDA has accepted the investigational new drug (IND) application for Eyenovia’s MicroStat, the New York company announced Nov. 13. MicroStat is a first-in-class fixed combination of phenyleph...
Johnson & Johnson Teams with Singapore National Eye Centre, Singapore Eye Research Institute to Halt Myopia
The Singapore National Eye Centre (SNEC), the Singapore Eye Research Institute (SERI), and Johnson & Johnson Vision announced Nov. 12 that they have partnered in a $26.35 million research collabora...
Bionic Vision’s Retinal Prosthesis Implanted in Four RP Patients in Clinical Trial
Bionic Vision Technologies reported Nov. 19 that medical researchers used the company’s retinal prosthesis to restore a sense of vision in four blind patients with retinitis pigmentosa during a cli...
Alcon, Verily Stop Pursuit of Glucose-Sensing Contact Lens
Alcon and Verily have put “on hold” their pursuit of a glucose-sensing contact lens for people with diabetes, but they will continue to partner on two other ophthalmic projects, Verily announced No...
SEC, Mazzo Agree to Resolve Insider Trading Claims
The SEC has reached a deal with James Mazzo to resolve its insider trading claims against the ophthalmic industry veteran, the commission announced Nov. 13. In exchange for the commission dropping ...
Opternative Secures $9 Million in Latest Funding
Opternative has secured $9 million in its latest round of funding, the Chicago-based online vision test company announced Nov 8. Opternative said it will use the funding to double its engineering, ...
Cost Control, Innovation are Central Themes at 2018 AAO Meeting
Cost control and innovation were two major chords struck throughout the 2018 meeting of the American Academy of Ophthalmology (AAO), starting with the opening session. George Williams, MD (US), pre...
New Tech Dominates Device Sessions at AAO Meeting, as IOLs Take Back Seat
Much of the interest on the surgical front at the 2018 AAO meeting centered around Carl Zeiss Meditec’s acquisition of IanTECH on Oct. 23. Reno, Nevada-based IanTECH developed the miLOOP device for...
White House Targets Price of Ophthalmic Drugs
Ophthalmology is a target for new measures to bring down health care costs announced Oct. 25 by President Donald Trump and his administration. One proposal would peg the prices of biologic drugs in...
AAO Refractive Day Program Reflects on 30 Years of LVC Progress
Refractive Subspecialty Day at the 2018 AAO meeting began with Marguerite McDonald, MD (US), providing a history of laser vision correction. McDonald performed the first laser vision correction pro...
Breakfast Session at OIS Debates Future Market for New Retinal Candidates
A new anti-VEGF treatment for retinal disease must offer five to seven lines of visual improvement to convince practitioners to shift from off-label use of Avastin, the cheapest and most popular an...
Ophthalmic Deals: Retinal Gene Therapy Developers Capture Top Share of Funds
Ophthalmology remains one of the most active areas of medical technology investment, attracting monies from venture capitalists, public markets, large ophthalmic companies, and private equity. Rece...
Market Report: Perimetry Device Market to Generate $264 Million in 2018
The perimetry device market will generate revenues of $264 million in 2018, and the market will grow to $294 million by 2023 at a compound annual growth rate of 2.2 percent, according to Market Sco...
Omeros Leads Latest Fundraising Efforts with $210 Million in Private Offering
Omeros led recent fundraising efforts by ophthalmic companies, raising $210 million through a private offering of convertible senior notes due in 2023. Other firms with financing deals include Clem...
Allergan Loses Appeal on Restasis Patents, Opening Door for Generics
The US Court of Appeals for the Federal Circuit in Washington on Nov. 13 affirmed a lower court decision invalidating the patents for Restasis. The appeals court made its ruling a week after it hea...
Ophthotech Acquires Inception 4, Signs Option Agreement for Gene Therapy Candidates
Ophthotech Corporation announced Oct. 31 that it acquired Inception 4, a privately held company backed by Versant Ventures. New York-based Ophthotech also announced an agreement with two universiti...
Vital Tears Adds Mobile Service for its Autologous Serum Tears for Dry Eye
Vital Tears announced Nov. 7 that it has added mobile phlebotomy services to its system of providing autologous serum tears for dry eye disease. Autologous serum tears combine a patient’s own blood...
Oncobiologics Begins Dosing Patients in Study of Bevacizumab Candidate for Wet AMD
Oncobiologics announced Nov. 6 that it has begun dosing patients in its first clinical trial for ONS-5010, a proprietary ophthalmic bevacizumab candidate being studied as a treatment for wet age-re...
US FDA Seeks More Information on Regeneron’s Eylea Prefilled Syringe
Regeneron announced Oct. 25 that it received a complete response letter from the US FDA for its supplemental application for Eylea prefilled syringe. The Tarrytown, New York, company said the FDA r...
SEC, Mazzo Agree to Settle Insider Trading Claims
The SEC has reached a deal with James Mazzo to resolve its insider trading claims against the ophthalmic industry veteran, the commission announced Nov. 13. In exchange for the commission dropping ...
November 2018 Ophthalmic News Briefs
Eyevance Acquires US Commercial Rights to FLAREX from Novartis Eyevance Pharmaceuticals has acquired FLAREX from Switzerland-based Novartis AG, the Fort Worth, Texas-based company announced Oct. 24...
Allergan Loses Appeal on Restasis Patents, Opening Door for Generics
The US Court of Appeals for the Federal Circuit in Washington on Nov. 13 affirmed a lower court decision invalidating the patents for Restasis. The appeals court made its ruling a week after it hea...
Ophthotech Drops Wet AMD Program for Zimura to Focus on Other Indications
Ophthotech has dropped its pursuit of a wet age-related macular degeneration (AMD) indication for Zimura in combination with Lucentis, the New York-based company announced Nov. 13. Zimura combinati...
Omeros Announces $210 Convertible Debt Offering
Omeros Corporation is looking to raise $210 million in a convertible debt offering, the Seattle-based company announced Nov. 13. The company has granted initial purchasers of the notes an option to...
4D Molecular Therapeutics Gains Orphan Drug Designation for Choroideremia Treatment
The US FDA has granted orphan drug designation to 4D Molecular Therapeutics’ treatment candidate for choroideremia, 4D-110, the Emeryville, California, company announced Nov. 16. 4D-110 is administ...
AsclepiX Raises $5 Million in Support of Candidate for DME, AMD
AsclepiX Therapeutics announced Nov. 13 that it has raised $5 million in convertible note funding. The Baltimore company said it will use the funds to develop AXT107, its treatment candidate for di...
RetiPharma Nets $1.48 Million to Develop Degenerative Eye Disorder Treatments
RetiPharma has secured funding from the Novo Nordisk Foundation’s BioInnovation Institute (BII) in the form of a convertible note to be paid in tranches totaling €1.3 million (about $1.48 million),...
Notal Vision Appoints Susan Orr as CEO
Notal Vision has appointed Susan Orr, OD, to become its next CEO, effective Jan. 1, 2019, the company announced Nov. 1. Orr will replace Quinton Oswald, who will retire at the end of 2018 but will ...
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DJO Partners With SirenMD
DJO announced a new partnership with SirenMD on Nov. 7. SirenMD is a coordinated care system that allows caretakers to collaborate on patient cases without delays or HIPAA violations. DJO is now th...
Shriners Hospitals Partners With Tonic Health
Tonic Health, based in California, announced Nov. 6 that Shriners Hospital for Children is expanding its use of Tonic’s patient survey across the US. Shriners’ goal is to build the largest database...
New CEO, CFO for EOS imaging
EOS imaging announced Nov. 5 that it has appointed Mike Lobinsky as its new CEO and Valerie Worral as CFO. Lobinsky has been the president of EOS in North America since August 2017, and he will con...
RTI Surgical Acquires Paradigm Spine
Michigan-based RTI Surgical Inc. announced Nov. 1 that it acquired privately owned Paradigm Spine LLC for approximately $300 million. Half of the payment will be delivered at closing; the rest will...
Oncobiologics Begins Dosing Patients in Study of Bevacizumab Candidate for Wet AMD
Oncobiologics announced Nov. 6 that it has begun dosing patients in its first clinical trial for ONS-5010, a proprietary ophthalmic bevacizumab candidate being studied as a treatment for wet age-re...
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Ophthotech Acquires Versant Ventures-Backed Inception 4
Ophthotech Corporation has acquired Inception 4, a privately held company backed by Versant Ventures, Ophthotech announced Oct. 31. New York-based Ophthotech acquired worldwide development and comm...
US Grand Jury Indicts Former Genentech Employees with Stealing Secrets for Chinese Firm
A US federal grand jury has indicted three former Genentech employees with stealing trade secrets from Genentech and funneling them to JHL Biotech, a China-based company developing biosimilars, acc...
Vital Tears Adds Mobile Service for its Autologous Serum Tears for Dry Eye
Vital Tears announced Nov. 7 that it has added mobile phlebotomy services to its system of providing autologous serum tears for dry eye disease. Autologous serum tears combine a patient’s own blood...
DJO’s OaraScore Assesses Appropriate Length of Stay
DJO announced the launch of its Outpatient Arthroplasty Risk Assessment tool, OaraScore, on Nov. 1. OaraScore is designed to generate consistent length-of-stay recommendations for patients undergoi...
Denosumab Effective for TDT-induced Osteoporosis in Phase IIb Study
Results from an Amgen-funded Phase IIb clinical trial were announced on Oct. 31. Researchers studied the effect of denosumab, a human monoclonal antibody that selectively inhibits RANKL, on transfu...
Amedica Becomes SINTX
Utah-based Amedica Corporation announced its new name, SINTX Technologies Inc., on Oct. 31. The Amedica name will remain as part of CTL-Amedica’s title. CTL’s acquisition of Amedica’s spine busines...
Vivex Announces New CEO
Atlanta company Vivex Biomedical Inc. announced Lisa Colleran as its new CEO on Oct. 23. Colleran is taking Tracy Anderson’s place; Anderson is the company’s founder. Previously, Colleran was the C...
AAOS Launches Shoulder, Elbow Registry
The American Academy of Orthopaedic Surgeons (AAOS) announced Oct. 24 that it has begun collecting total shoulder arthroplasty (TSA) data for its Shoulder and Elbow Registry (SER). Rotator cuff rep...
Hinge Health Saves Money, Reduces Opioid Use in Employer Study
San Francisco-based Hinge Health announced results from an employer study on Oct. 30. The employer tested Hinge Health’s digital back and knee pain care programs on 415 employees. Hinge’s programs ...
Bausch + Lomb’s Q3-2018 Revenues Decline 7 Percent, Despite Volume Increases in Segment
The Bausch + Lomb/International segment of Bausch Health Companies reported Q3-2018 revenues of $1.15 billion, compared with $1.23 billion in Q3-2017, a decline of about $87 million, or 7 percent (...
Positive Study Results for Tanezumab in OA Patients
Pfizer Inc. and Eli Lilly and Company announced positive Phase III trial results for Tanezumab on Oct. 23. The companies began a global co-development and commercialization agreement for the drug i...
Cosentyx Shows Long-term Response for Ankylosing Spondylitis
Novartis announced new data for Cosentyx (secukinumab) on Oct. 22 from its Measure 2 study. Cosentyx is a human monoclonal antibody that acts as an IL-17A antagonist. The study data showed that 73....
Former Valeant Executive, Philidor CEO Sentenced for Scheme to Defraud Drugmaker
Former Valeant executive Gary Tanner and former Philidor Rx CEO Andrew Davenport were sentenced to one year in prison Oct. 30 after being convicted of defrauding Valeant in a multimillion dollar fr...
Omeicos Therapeutics Closes $19.5 Million Series C Financing
Omeicos Therapeutics has closed a $19.5 million Series C financing, the company announced Nov. 2. The Berlin-based company said the funding will be used to fund a clinical trial for a non-ophthalmi...
Clearside Stops Xipere’s RVO Program, Focuses on Uveitis Indication
Clearside Biomedical announced Nov. 5 that it would discontinue its clinical program for Xipere as a treatment for retinal vein occlusion after it missed its primary endpoint in the SAPPHIRE Phase ...
Millennial Demographics Drive Refractive Surgery Opportunity in US
Market Scope’s 2018 Refractive Atlas includes a comprehensive profile of 85 high-opportunity geographic hot spots for refractive surgery. Wealth, health, and education are key factors in determinin...
STAAR Surgical’s Net Sales in Q3-2018 Increase 35 Percent
STAAR Surgical’s net sales in Q3-2018 totaled $31.8 million, an increase of 35 percent over $23.5 million in Q3-2017. The company attributed the growth to expanding use of its EVO Visian ICL family...
Apellis Pauses GA Trial due to Inflammation
Apellis Pharmaceuticals has paused dosing in its Phase III clinical trial in geographic atrophy (GA) due to patients developing non-infectious inflammation from a single lot of APL-2, the company r...
Allergan Raises Full-Year Outlook as Restasis Revenues Fall Less than Expected
Restasis sales in Q3-2018 declined 18.8 percent year over year, but Allergan told analysts Oct. 30 that the dry eye drug outperformed expectations due to delayed generic competition. As a result, D...
Topcon Releases Harmony Ophthalmic Data Management Software
Topcon Health Solutions announced Oct. 22 the launch of its newly cleared Harmony software. The next-generation software for ophthalmic data management replaces the Synergy platform. Harmony has a ...
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Zilretta Trial Results Show Bilateral Knee OA Treatment is Safe
Massachusetts company Flexion Therapeutics Inc. announced results of its Phase II trial for Zilretta (triamcinolone acetonide extended-release injectable suspension) on Oct. 22. The trial tested th...
Clearside Names Thomas Ciulla, MD, Chief Medical Officer
Clearside Biomedical has appointed Thomas A. Ciulla, MD, MBA, to be its chief medical officer, the Alpharetta, Georgia, company announced Oct. 25. Ciulla is a board certified ophthalmologist and re...
US FDA Seeks More Information on Regeneron’s Eylea Prefilled Syringe
Regeneron announced Oct. 25 that it received a complete response letter from the US FDA for its supplemental application for Eylea prefilled syringe. The Tarrytown, New York, company said the FDA r...
ProQR Licenses Global Rights for RP Candidate from Ionis
ProQR Therapeutics announced Oct. 29 that it has signed an agreement with Ionis Pharmaceuticals to license QR-1123, an RNA candidate for autosomal dominant retinitis pigmentosa (adRP) caused by the...
Filgotinib Trial Shows Promise for Ankylosing Spondylitis
Results from the TORTUGA Phase II trial were published on The Lancet’s website Oct. 22. This study investigated the safety and efficacy of filgotinib for ankylosing spondylitis patients who have no...
Novartis Teams with Compact Imaging on AMD, DR Home Monitor
Compact Imaging has agreed to collaborate with Novartis to develop a low-cost home-based monitor for age-related macular degeneration (AMD) and diabetic retinopathy (DR), CI announced Oct. 26. The ...
Ophthotech Signs Option Agreement for Gene Therapy Candidates for Best Disease
Ophthotech has an option agreement with the University of Pennsylvania (Penn) and the University of Florida Research Foundation (UFRF) to negotiate an exclusive global license to develop and commer...
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Clementia, Developer of a Dry Eye Candidate, Announces $72 Million Public Offering
Clementia Pharmaceuticals announced a $72 million public offering of 5.3 million shares at $13.25 per share, the Montreal-based company announced Oct. 29. The clinical-stage biopharmaceutical compa...
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NuVasive Names Barry CEO, Promotes Link
J. Christopher Barry will take Gregory Lucier’s place as NuVasive’s CEO, the company announced Oct. 19. Barry has most recently served as president of Surgical Innovations at Medtronic. NuVasive al...
Oyster Point Reports Positive Phase IIb Results for Nasal Spray Candidates for Dry Eye
Oyster Point Pharma announced Oct. 24 that its two dry eye candidates produced positive results in the ONSET and RANIER Phase IIb clinical trials. OC-01 and OC-02 are different nicotine acetylcholi...
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