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Regeneron Gains Emergency Use Authorization for its Cocktail Treatment for COVID-19

Regeneron gained FDA emergency use authorization Nov. 1 for REGEN-COV2, a onetime injection of the monoclonal antibodies casirivimab and imdevimab, as a treatment for COVID-19. REGEN-COV2 is author...

Kodiak Leads Latest Fundraising Efforts with $645 Million Offering

Kodiak Sciences, of Palo Alto, California, led recent fundraising efforts by ophthalmic companies, with a $645 million underwritten public offering of common stock. Funding for the past four weeks ...

November 2020 Ophthalmic News Briefs

Norlase announced on Oct. 28 510(k) clearance from the US FDA and the immediate commercial launch of Norlase LION, a green laser photocoagulator fully integrated into the headset of a Keeler indire...

Kodiak Sciences Prices $560.9 Million Public Offering of Common Stock

Kodiak Sciences announced Nov. 17 that it had priced 5.2 million shares of its common stock at $108 per share in an underwritten public offering, with gross proceeds expected at $560.9 million. The...

Ophthalmic Devices Panel Votes Against Recommending VisAbility

The US FDA’s Ophthalmic Devices Panel voted 15-1 against recommending Refocus Group’s VisAbility Micro Insert System as a presbyopia treatment in a virtual advisory meeting held Nov. 9. The company...

Adaptilens Raises $1.6 Million in Seed Funding for Development of Accommodating IOL

Adaptilens announced Nov. 12 that it had completed a $1.6 million seed funding for development of an accommodating IOL. The Boston-based company said funding was led by Pillar VC, with participatio...

Leo Lens Pharma Announces IND Submission, $3 Million-Plus Seed Funding

Leo Lens Pharma announced Nov. 12 that it had closed on a seed funding round of more than $3 million and had filed an investigational new drug (IND) application with the US FDA for its bimatoprost-...

Ocuphire Announces $1.7 Million NIH Grant to Study Oral Tablet for Retina

Ocuphire Pharma announced Nov. 16 that Mark R. Kelley, PhD, a member of Ocuphire’s Medical Advisory Board, was awarded a $1.7 million grant from the National Institutes of Health’s National Eye Ins...

Stoke Names Next Target of Study in Inherited Optic Nerve Disorder

Stoke Therapeutics, of Bedford, Massachusetts, announced Nov. 12 that its next preclinical target would be OPA1 for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherit...

Q3-2020 Earnings Roundup: Alcon, Bausch, Glaukos, Six Others

Alcon reported Nov. 10 that its Q3-2020 sales were $1.82 billion, a decrease of 1 percent from $1.84 billion in Q3-2019. Sales for the first nine months of 2020 were $4.84 billion, a decline of 12 ...

Surgeons Describe Pivoting in Pandemic During Zeiss Virtual Event at AAO Meeting

Three ophthalmic surgeons provided insights into how Zeiss technology helped them pivot during the pandemic—and how there is no going back to slower and less efficient workflows—in a Zeiss press co...

I-MED Pharma launches E-Swin’s Tearcheck in Canada

I-MED Pharma announced on Nov. 10 the launch in Canada of Tearcheck, a new diagnostic and analyzing tool that the company says can perform nine different dry eye exams in under 10 minutes. Tearchec...

First Patient Completes Three-Year Enrollment in Phase III Study of Nevakar’s Childhood Myopia Candidate

Nevakar, of Bridgewater, New Jersey, announced Nov. 9 that the first patient had completed three-year enrollment in its Phase III CHAMP (Childhood Atropine for Myopia Progression) study, evaluating...

Gyroscope Announces First Patient Dosed in Phase II Trial of GA Gene Therapy Candidate

Gyroscope Therapeutics, of London, announced Nov. 11 the initiation of the Phase II HORIZON trial evaluating its GT005 gene therapy in people with geographic atrophy (GA) secondary to dry age-relat...

Q3-2020 Earnings Roundup: Horizon, Regeneron, STAAR, EyePoint, Six Others

Horizon Therapeutics reported Nov. 2 that it saw record Q3-2020 net sales of $636.4 million, an increase of 90 percent year over year. The company’s thyroid eye disease treatment, Tepezza (teprotum...

Aurinia Suspends Dry Eye Program after Voclosporin Fails to Meet Phase II/III Primary Endpoint

Aurinia Pharmaceuticals announced Nov. 2 that it would be suspending its dry eye program after its voclosporin ophthalmic solution (VOS) failed to meet its primary endpoint in a Phase II/III trial....

Novartis Acquires Ophthalmic Gene Therapy Company Vedere Bio

Vedere Bio, of Cambridge, Massachusetts, announced Oct. 29 that it had been acquired by Novartis. Vedere is advancing photoreceptor-protein-based AAV gene therapies that are delivered to the retina...

Apellis Licenses Systemic Pegcetacoplan to Sobi for potential $1.25 Billion, Keeps Ophthalmic Rights

Apellis Pharmaceuticals announced Oct. 27 that Swedish company Sobi would co-develop systemic pegcetacoplan in a deal worth a potential $1.25 billion to Apellis. The agreement gives Sobi exclusive ...

Henlius Licenses Ophthalmic Bevacizumab Candidate to Essex in Deal for $43 Million, Plus Sales Payments

Shanghai Henlius Biotech, of China, announced Oct. 15 that it would co-develop its bevacizumab candidate, HLX04, for ophthalmic diseases with Zhuhai Essex, also of China, and exclusively license th...

New Pledge to Synedgen Mustard Gas Treatment Program Pushes NEI Funding Past $1 Million

Synedgen, of Claremont, California, announced Oct. 29 that the National Eye Institute (NEI) had offered supplemental funding to help Synedgen identify a lead molecule from the company’s ocular must...

First Patient Receives STAAR EVO Viva as Commercialization Begins in Europe

STAAR Surgical announced Nov. 4 that the first patient had received its EVO Viva presbyopia-correcting lens as commercialization gets underway in Europe. Caren Mason, president and CEO of STAAR Sur...

AMA Grants Category I CPT Code for Drug-Eluting Intracanalicular Inserts Such as Dextenza

Ocular Therapeutix, of Bedford, Massachusetts, announced Nov. 4 that its application for the creation of a Category I Current Procedural Terminology (CPT) procedure code covering drug-eluting intra...

US FDA Approves Kala’s Eysuvis for Short-Term Treatment of Signs, Symptoms of Dry Eye

Kala Pharmaceuticals announced Oct. 27 that the US FDA had approved Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and sympt...

Norlase Announces US FDA Clearance and US Launch of New LION Laser System

Norlase announced on Oct. 28 510(k) clearance from the US FDA and the immediate commercial launch of Norlase LION, a green laser photocoagulator fully integrated into the headset of a Keeler indire...

Bausch + Lomb Introduces SimplifEYE Delivery System For enVista Preloaded IOLs

Bausch + Lomb announced on Oct. 27 the introduction of the SimplifEYE intraocular lens (IOL) delivery system, available exclusively for the enVista MX60PL and the enVista toric MX60PT, the first pr...

Nova Eye Medical Establishes Subsidiary to Support Laser Therapy for AMD

Nova Eye Medical, formerly Ellex, announced Oct. 26 the establishment of a subsidiary called AlphaRET to support the commercial development of its 2RT laser therapy for intermediate age-related mac...

Santen Licenses Aerie’s Rhopressa, Rocklatan in Japan and Several Other Asian Countries

Santen and Aerie have entered into an exclusive development and commercialization agreement for Aerie’s Rhopressa and Rocklatan glaucoma drops in Japan, along with rights for several other Asian co...

US Accepts NDA Filing for Santen’s Cyclosporine for Severe VKC in Children

Santen Inc., the US subsidiary of Japan’s Santen Pharmaceutical Co. Ltd., announced Oct. 26 that the US FDA had accepted the new drug application (NDA) for its cyclosporine topical ophthalmic emuls...

Vanda Gains FDA Nod to Proceed with Trials of VSJ-110 for Allergic Conjunctivitis

Vanda Pharmaceuticals announced Oct. 26 that the US FDA had approved its investigational new drug (IND) application to evaluate VSJ-110, a cystic fibrosis transmembrane conductance regulator (CFTR)...

TearSolutions Releases Trial Results of Lacripep for Sjögren’s, Appoints Asrani President and CEO

TearSolutions released Oct. 26 preliminary outcomes of a Phase I/II trial of its Lacripep in primary Sjögren’s syndrome patients. Sjögren’s patients suffer from a severe and often debilitating form...

Allergan Sees Positive Phase III Results for Presbyopia Drop Candidate

Allergan, an AbbVie company, announced Oct. 28 that AGN-190584 (pilocarpine 1.25%) ophthalmic solution for symptoms of presbyopia met its primary efficacy endpoint in two Phase III trials. Allergan...

Nicox Selects Glaucoma Candidate from New Class of NO-Mediated IOP-Lowering Agents

France-based Nicox announced Oct. 23 that it has selected a new development candidate, NCX 1728, for lowering intraocular pressure (IOP) in glaucoma patients. Michele Garufi, chairman and chief exe...

Do Virtual Attendees Need Breaks? Conferences Take Different Approaches

Three online meetings during the first week of October showcased different ideas about how to structure a virtual conference. The two Ophthalmology Futures Forums (Retina and European) were held Se...

ESCRS Speakers Expect Hybrid Lenses to Expand PC-IOLs’ Market Share in Europe

New hybrid categories of presbyopia-correcting IOLs (PC-IOLs) were the focus of meeting sessions and company-sponsored satellite programs at the 2020 virtual congress of the European Society of Cat...

BVI Acquires Benz as it Continues to Build Formidable Player in Ophthalmology

BVI’s acquisition of Benz Research & Development is part of its strategy to become an ophthalmic stalwart, the Waltham, Massachusetts, company told Market Scope on Oct. 28. Benz is a leading source...

Companies Extending Special Purchase Options for Ophthalmic Surgeons, COVID-19 Survey Shows

Some companies are providing assistance to ophthalmologists for capital equipment purchases in hopes of reducing the financial burden, given that surgeons are considering delaying such purchases, l...

Bausch Licenses Eyenovia’s Pediatric Myopia Candidate in US, Canada, Adding to Acquisitions

Bausch + Lomb has licensed in the US and Canada Eyenovia’s microdose formulation of atropine ophthalmic solution, which is being investigated for the reduction of pediatric myopia progression. Eyen...

Eli Lilly to Acquire Disarm Therapeutics for $135 Million, Plus Potential Milestone Payments

Eli Lilly and Company announced Oct. 15 that it had agreed to acquire Disarm Therapeutics, a Cambridge, Massachusetts, company developing preclinical SARM1 inhibitors for axonal degeneration. Glauc...

Katena Acquires Micro-Select Instruments

Katena Products of Parsippany, New Jersey, announced Oct. 20 that it had acquired Micro-Select Instruments of St. Clair, Missouri. Financial details were not released. Micro-Select, founded in 2005...

DMEK Procedures, Pandemic’s Impact Among Cornea Topics at ESCRS

Heidelberg University Hospital’s eight-minute film “CSI Heidelberg: DMEK with Artificial Implant Instead of Human Tissue” was awarded first prize in the innovative category in the European Society ...

ESCRS Sessions Look at Dry Eye, Drug Delivery, Glaucoma Pipeline

Presenters at the 2020 congress of the European Society of Cataract and Refractive Surgeons (ESCRS) discussed how dry eye affects visual acuity and patient satisfaction after cataract or refractive...

Retinal Implants, Pragmatic Approaches to GA Grab Spotlight at Virtual EURETINA 2020

Highlights of the EURETINA 2020 Virtual congress included presentations on new medical devices, surgical techniques, and in-depth discussions of geographic atrophy. New devices discussed at EURETIN...

FLACS Costs, Quick Recall of CyPass Among Debates at Ophthalmology Futures Virtual European Forum

The Ophthalmology Futures Forums, now consisting of two sessions (European and Retina), shifted to a virtual, Zoom-based platform this year. Much like other industry meetings, the forums waived reg...

Challenges for Surgeons Highlight Ophthalmology Futures Retina Forum

Frank discussions and company presentations (see the accompanying table) were the order of the day for 719 participants in the Ophthalmology Futures Virtual Retina Forum on Sept. 30. The panel on a...

Developers of CRISPR Gene-Editing Technology Receive Nobel Prize in Chemistry

Researchers Jennifer Doudna and Emmanuelle Charpentier have received the Nobel Prize in Chemistry in 2020 for the development of a method for gene editing, the Royal Swedish Academy of Sciences ann...

Concerns Over Surgical Waste Cloud Future of Single-Use Device Market

The global single-use surgical device market has shown steady growth over several decades, reaching a peak of $3.4 billion in 2019, but growing concerns over the amount of waste created by disposab...

Dr. Reddy’s Launches Two OTC Olopatadine Formulations in US

Dr. Reddy’s Laboratories, based in Hyderabad, India, reported Sept. 17 that it had launched its over-the-counter Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% and 0.1%, in the US. Both fo...

Cornea Products Market to Grow an Estimated 6.1 Percent Through 2025

Expanding use of products to treat many corneal diseases will increase the role of devices and surgery in the cornea treatment landscape. Over 1 billion people are affected by 50 corneal diseases t...

Nova Eye Medical Establishes Subsidiary to Support Laser Therapy for AMD

Nova Eye Medical, formerly Ellex, announced Oct. 26 the establishment of a subsidiary called AlphaRET to support the commercial development of its 2RT laser therapy for intermediate age-related mac...

Opthea Leads Latest Fundraising Efforts with $128.2 Million US IPO

Australian company Opthea led recent fundraising efforts by ophthalmic companies, raising $128.2 million in its initial public offering on the US Nasdaq market. Funding for the past four weeks tota...

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