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US FDA Approves Genentech’s Vabysmo for Patients with Retinal Vein Occlusion
US FDA Approves Genentech’s Vabysmo for Patients with Retinal Vein Occlusion

Genentech, a member of the Roche Group, announced Oct. 27 that the US FDA had approved Vabysmo (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). RVO is the...

EyeBio Leads Latest Ophthalmic Fundraising with $65 Million in Series A
EyeBio Leads Latest Ophthalmic Fundraising with $65 Million in Series A

EyeBio led recent ophthalmic fundraising efforts with $65 million in Series A funding to continue development of its candidate for retinal disease. Financing announced in the past four weeks totale...

Select US FDA Approvals and Clearances in October 2023
Select US FDA Approvals and Clearances in October 2023

The US FDA granted five clearances through the ophthalmic device division using the 510(k) pathway in October 2023, according to the agency’s database. Heidelberg gained market clearance for its An...

Outlook Plans New Clinical Trial for Lytenava After Meeting with US FDA
Outlook Plans New Clinical Trial for Lytenava After Meeting with US FDA

Outlook Therapeutics reported Nov. 2 that it plans to hold another clinical trial of Lytenava, an ophthalmic formulation of bevacizumab, for wet age-related macular degeneration (AMD), in the wake ...

US Dominance of Premium Cataract Surgery Market Expected to Grow
US Dominance of Premium Cataract Surgery Market Expected to Grow

New technology and competition are expected to further expand the dominance of the US premium cataract surgery (PCS) market over the next five years. The US is already the dominant PCS market globa...

Stuart Therapeutics Licenses its Glaucoma Neuroprotection Candidate to Glaukos
Stuart Therapeutics Licenses its Glaucoma Neuroprotection Candidate to Glaukos

Stuart Therapeutics announced Oct. 18 that it had granted Glaukos exclusive worldwide rights to develop and commercialize Stuart’s ST-113 drug candidate for neuroprotection in glaucoma. ST-113 is a...

Clinical Trial Updates for Ophthalmic Candidates
Clinical Trial Updates for Ophthalmic Candidates

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements. Date Company Candidate, Indication Milestone Notes Nov. 2 PolyActiva PA5108 sustained-releas...

Euretina Prepares European Doctors for the GA Revolution
Euretina Prepares European Doctors for the GA Revolution

The 2023 Euretina congress presented an array of information and technologies that could make European retina specialists better prepared for the arrival of treatments for geographic atrophy than w...

Europe Still in Grips of Visudyne Shortage
Europe Still in Grips of Visudyne Shortage

The Visudyne shortage is into its third year in Europe after emerging in May 2020 due a reduction in manufacturing capacity, according to the European Medicines Agency. The shortage made the questi...

2023 AAO Meeting Draws 15,661 to San Francisco
2023 AAO Meeting Draws 15,661 to San Francisco

The 2023 meeting of the American Academy of Ophthalmology drew 15,661 in-person attendees Nov. 3-6 to Moscone Center in San Francisco, according to preliminary numbers released by the AAO. Another ...

Buzzworthy Topics at the 2023 AAO Meeting
Buzzworthy Topics at the 2023 AAO Meeting

Dry Eye: New products kept generating buzz around dry eye. Bausch + Lomb leaned into the promotion of Miebo, the new, first-in-class drug therapy that directly targets tear evaporation. Diagnostic ...

Eyecelerator at AAO Showcases Innovators and Awards $45 Thousand in Prize Money
Eyecelerator at AAO Showcases Innovators and Awards $45 Thousand in Prize Money

Eyecelerator awarded a total of $45 thousand in prize money to winning pitch challengers at its fall meeting, after emerging companies got a chance to work with accomplished industry veterans to re...

RxSight Announces Controlled Launch of LAL+ with Extended EDOF Functionality
RxSight Announces Controlled Launch of LAL+ with Extended EDOF Functionality

RxSight—already the fastest growing IOL company in the US—is conducting a controlled launch of an additional version of the Light Adjustable Lens (LAL), referred to as the LAL+. Stephen Slade, MD, ...

Surgeons Compare Trifocal and EDOF IOLs During AAO Refractive Day
Surgeons Compare Trifocal and EDOF IOLs During AAO Refractive Day

Trifocal IOLs went head-to-head with extended depth of focus lenses during the 2023 AAO Refractive Day program as Damien Gatinel, MD, PhD (France), advocated for trifocal models and Douglas Koch, M...

UCSF Ophthalmology Showcase Sends Message to Industry That It’s ‘Open for Business’
UCSF Ophthalmology Showcase Sends Message to Industry That It’s ‘Open for Business’

The University of California, San Francisco (UCSF), held its Ophthalmology Showcase on Nov. 3 to highlight both the school’s history of ophthalmic innovation and its role in future advancements. Th...

US Ophthalmologists Emphasize Action as Industry Inches Toward Greener Practices
US Ophthalmologists Emphasize Action as Industry Inches Toward Greener Practices

Sustainability sessions at the 2023 AAO meeting echoed the sentiment of the ESCRS and other ophthalmic meetings throughout the year. US ophthalmologists discussed how practices can implement protoc...

Diagnostic Leaders Showcase Devices, Collaborations at AAO Meeting
Diagnostic Leaders Showcase Devices, Collaborations at AAO Meeting

Notable diagnostic innovations showcased at the 2023 meeting of the American Academy of Ophthalmology were Topcon’s Tempo perimeter and Heidelberg Engineering’s Anterion anterior OCT platform. Also...

Five MACs Finalize Plans to Curb Coverage of Non-stent Glaucoma Procedures
Five MACs Finalize Plans to Curb Coverage of Non-stent Glaucoma Procedures

Five of the seven Medicare administrative contractors (MACs) in the US have issued their final reimbursement plans for minimally invasive glaucoma surgery (MIGS) procedures, confirming that they wo...

AbbVie Signs Option Deal with Aldeyra for License to Develop Reproxalap
AbbVie Signs Option Deal with Aldeyra for License to Develop Reproxalap

Aldeyra Therapeutics announced Nov. 1 that AbbVie had signed an exclusive option agreement to license to develop, manufacture, and commercialize reproxalap, Aldeyra’s candidate in development for d...

FDA Warns of Possible Bacterial Contamination in 27 OTC Eye Drop Products
FDA Warns of Possible Bacterial Contamination in 27 OTC Eye Drop Products

The US FDA issued a warning to consumers Oct. 27 to immediately stop using more than two dozen over-the-counter eye drop products due to the potential risk of blinding eye infections. The products ...

Bausch + Lomb Launches enVista Aspire Intermediate-Optimized Monofocal and Toric IOLs in US
Bausch + Lomb Launches enVista Aspire Intermediate-Optimized Monofocal and Toric IOLs in US

Bausch + Lomb announced Oct. 18 the US launch of its enVista Aspire monofocal and toric intraocular lenses with intermediate-optimized optics. The company said that, unlike conventional spherical m...

Weekly Surgeon Poll, November 2023
Weekly Surgeon Poll, November 2023

Emerging Companies Pursuing Ophthalmic Indications, November 2023
Emerging Companies Pursuing Ophthalmic Indications, November 2023

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease. Company Location About NVasc Atherton, California The company is developing a leukemia inhib...

November 2023 Ophthalmic News Briefs
November 2023 Ophthalmic News Briefs

Specialty pharma company Padagis announced Oct. 13 the launch of its brinzolamide ophthalmic suspension, a generic version of Novartis’ Azopt for glaucoma. Padagis, with offices in the US and Israe...

Q3-2023 Ophthalmic Revenue Roundup for Immunocore, Harrow, RxSight, and Three Others
Q3-2023 Ophthalmic Revenue Roundup for Immunocore, Harrow, RxSight, and Three Others

UK-headquartered Immunocore reported Nov. 7 that its Q3-2023 net revenue from Kimmtrak (tebentafusp) was £49.7 million ($60.7 million, converted at a rate of £1.00 to $1.2214), an increase of 9 per...

Lenz Plans Merger with Graphite Bio to Gain Nasdaq Listing, Advance Presbyopia Drop Candidate
Lenz Plans Merger with Graphite Bio to Gain Nasdaq Listing, Advance Presbyopia Drop Candidate

Privately held Lenz Therapeutics announced Nov. 15 that it had entered into an agreement to merge with Nasdaq-listed Graphite Bio in an all-stock transaction. The combined company would take the Le...

US FDA Gives Green Light to Trial of Inflammasome’s Sustained-Release Implant for GA
US FDA Gives Green Light to Trial of Inflammasome’s Sustained-Release Implant for GA

Inflammasome Therapeutics announced Nov. 13 that the US FDA had cleared a Phase I/II trial for its inflammasome inhibitor in a sustained-release ocular implant for geographic atrophy (GA), the adva...

Atsena Receives FDA’s RMAT Designation for LCA1 Gene Therapy Candidate
Atsena Receives FDA’s RMAT Designation for LCA1 Gene Therapy Candidate

Atsena Therapeutics announced Nov. 14 that its gene therapy candidate for Leber congenital amaurosis 1, ATSN-101, had received the US FDA’s regenerative medicine advanced therapy (RMAT) designation...

Visionix Forms Strategic Alliance with 20/20Now to Expand Tele-optometry
Visionix Forms Strategic Alliance with 20/20Now to Expand Tele-optometry

Visionix’ US division announced Nov. 10 that it had entered into a strategic alliance with 20/20Now to bring tele-optometry to more optical retailers. 20/20Now, of Holbrook, New York, offers a soft...

Q3-2023 Ophthalmic Revenue Roundup for Hoya, Lumibird, Sight Sciences, and Ocular Therapeutix
Q3-2023 Ophthalmic Revenue Roundup for Hoya, Lumibird, Sight Sciences, and Ocular Therapeutix

Japan-based Hoya Corporation reported Oct. 31 that its medical segment (IOLs, endoscopes, and artificial bone) generated revenue for the third quarter of 2023—its fiscal year Q2-2023—of ¥33.5 billi...

Kodiak Will Restart its Tarcocimab Program After Strong Results in Phase III DR Trial
Kodiak Will Restart its Tarcocimab Program After Strong Results in Phase III DR Trial

Kodiak Sciences announced Nov. 6 that it would restart its tarcocimab tedromer development program after strong positive results from a Phase III trial in diabetic retinopathy (DR). The Palo Alto, ...

Regenxbio Says it Will Cut Staff, Realign Pipeline Priorities to Extend Cash Runway
Regenxbio Says it Will Cut Staff, Realign Pipeline Priorities to Extend Cash Runway

Regenxbio announced in its Q3-2023 financial statement on Nov. 8 that it would cut its workforce by approximately 15 percent while prioritizing three gene therapy candidates with the largest commer...

Outlook Plans New Clinical Trial for Lytenava After Meeting with US FDA
Outlook Plans New Clinical Trial for Lytenava After Meeting with US FDA

Outlook Therapeutics reported Nov. 2 that it plans to hold another clinical trial of Lytenava, an ophthalmic formulation of bevacizumab, for wet age-related macular degeneration (AMD), in the wake ...

Ascidian Raises $40 Million in Series A Funding, Appoints Michael Ehlers as Interim President, CEO
Ascidian Raises $40 Million in Series A Funding, Appoints Michael Ehlers as Interim President, CEO

Ascidian Therapeutics announced Nov. 8 that it had raised $40 million in Series A extension funding from life sciences venture capital company Apple Tree Partners. Ascidian, of Boston, Massachusett...

Ace Vision Group Names Rob Kissling, MD, as Chief Medical Officer
Ace Vision Group Names Rob Kissling, MD, as Chief Medical Officer

Laser company Ace Vision Group announced Nov. 1 that it had named Rob Kissling, MD, as chief medical officer. Most recently, Kissling served as vice president of clinical and medical affairs at Bau...

Eye Exam Kiosk Developer EyeCheq Names Ruwan Silva, MD, as Chief Medical Officer
Eye Exam Kiosk Developer EyeCheq Names Ruwan Silva, MD, as Chief Medical Officer

EyeCheq announced Nov. 2 that it had appointed Ruwan Silva, MD, as chief medical officer. Silva completed his residency in ophthalmology at Bascom Palmer Eye Institute in Miami, Florida, and his vi...

Q3-2023 Ophthalmic Revenue Roundup for Regeneron, Bausch + Lomb, AbbVie, and Five Others
Q3-2023 Ophthalmic Revenue Roundup for Regeneron, Bausch + Lomb, AbbVie, and Five Others

Regeneron of Tarrytown, New York, reported Nov. 2 that its Q3-2023 US revenue for Eylea (aflibercept) 2 mg and Eylea HD (a higher dose of aflibercept at 8 mg) was $1.49 billion, with Eylea HD accou...

AbbVie Signs Option Agreement with Aldeyra for License to Develop and Commercialize Reproxalap
AbbVie Signs Option Agreement with Aldeyra for License to Develop and Commercialize Reproxalap

Aldeyra Therapeutics announced Nov. 1 that AbbVie had signed an exclusive option agreement to license to develop, manufacture, and commercialize reproxalap, Aldeyra’s candidate in development for d...

Oertli Files for US FDA 510(k) Clearance for Phaco Portion of Lensar Ally System
Oertli Files for US FDA 510(k) Clearance for Phaco Portion of Lensar Ally System

Lensar and Swiss company Oertli announced Oct. 30 that Oertli had filed for US FDA 510(k) clearance for its Faros easyPhaco phacoemulsification system. If cleared, the Faros will be integrated into...

US FDA Warns of Possible Bacterial Contamination in 27 Over-the-Counter Eye Drop Products
US FDA Warns of Possible Bacterial Contamination in 27 Over-the-Counter Eye Drop Products

The US FDA issued a warning to consumers Oct. 27 to immediately stop using more than two dozen over-the-counter eye drop products due to the potential risk of blinding eye infections. The products ...

Bausch + Lomb Launches SeeNa Optical Biometry and Topography System in the US
Bausch + Lomb Launches SeeNa Optical Biometry and Topography System in the US

Bausch + Lomb announced on Oct. 30 the US launch of its SeeNa ophthalmic diagnostic system for refractive cataract patients, designed for integration with the company’s Eyetelligence surgical plann...

Aeye Health, Topcon Partner to Deliver AI-Aided Point-of-Care Screening for DR
Aeye Health, Topcon Partner to Deliver AI-Aided Point-of-Care Screening for DR

Aeye Health and Topcon’s diabetic point-of-care eye exam arm, Topcon Screen, announced Oct. 27 that they would partner to deliver artificial intelligence-aided screening for diabetic retinopathy (D...

Bruder Introduces Air-Activated Moist Heat Eyedration Mask for Dry Eye Relief
Bruder Introduces Air-Activated Moist Heat Eyedration Mask for Dry Eye Relief

Bruder Healthcare, of Alpharetta, Georgia, announced Oct. 20 that it had added a single-use, air-activated moist heat mask to its line of dry eye relief products. Bruder said the Eyedration mask be...

Ocuphire Pharma Appoints George Magrath, MD, as Chief Executive Officer
Ocuphire Pharma Appoints George Magrath, MD, as Chief Executive Officer

Ocuphire Pharma announced Nov. 1 that it had appointed George Magrath, MD, as chief executive officer and a member of its board of directors. Magrath succeeds Rick Rodgers, interim CEO and presiden...

Australia’s Opthea Appoints Fred Guerard, PharmD, as US-Based CEO
Australia’s Opthea Appoints Fred Guerard, PharmD, as US-Based CEO

Australian company Opthea announced Oct. 27 that the company’s chief executive officer, Megan Baldwin, PhD, will transition to founder and chief innovation officer, and that US-based Frederic Guera...

Bausch + Lomb Launches enVista Aspire Intermediate-Optimized Monofocal and Toric IOLs in US
Bausch + Lomb Launches enVista Aspire Intermediate-Optimized Monofocal and Toric IOLs in US

Bausch + Lomb announced Oct. 18 the US launch of its enVista Aspire monofocal and toric intraocular lenses with intermediate-optimized optics. The company said that, unlike conventional spherical m...

Q3-2023 Ophthalmic Revenue Roundup for Roche, Novartis, J&J Vision, and Nicox
Q3-2023 Ophthalmic Revenue Roundup for Roche, Novartis, J&J Vision, and Nicox

Swiss company Roche reported Oct. 19 that Q3-2023 Vabysmo sales were CHF 656 million ($732 million, converted Oct. 19), a 309 percent increase over CHF 173 million in Q3-2022. Vabysmo was approved ...

US FDA Approves Genentech’s Vabysmo for Retinal Vein Occlusion
US FDA Approves Genentech’s Vabysmo for Retinal Vein Occlusion

Genentech, a member of the Roche Group, announced Oct. 27 that the US FDA had approved Vabysmo (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). RVO is the...

Five New PC-IOLs Push Total to Nearly 100 in Europe
Five New PC-IOLs Push Total to Nearly 100 in Europe

European cataract surgeons now have access to nearly 100 presbyopia-correcting IOLs, after five new lenses made their debut at the 2023 congress of the European Society of Cataract and Refractive S...

Stuart Therapeutics Licenses its Glaucoma Neuroprotection Candidate to Glaukos
Stuart Therapeutics Licenses its Glaucoma Neuroprotection Candidate to Glaukos

Stuart Therapeutics announced Oct. 18 that it had granted Glaukos exclusive worldwide rights to develop and commercialize Stuart’s ST-113 drug candidate for neuroprotection in glaucoma. ST-113 is a...

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