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Kalaris Will Merge with AlloVir and Advance Candidate for Exudative Retinal Disease
Kalaris Will Merge with AlloVir and Advance Candidate for Exudative Retinal Disease

Kalaris Therapeutics announced Nov. 8 that it would merge with biotech company AlloVir in an all-stock transaction to advance Kalaris’ next-generation anti-VEGF candidate TH103 for exudative retina...

Advancium Signs Option to License Retinoblastoma Candidate from Aileron
Advancium Signs Option to License Retinoblastoma Candidate from Aileron

Aileron Therapeutics and Advancium Health Network announced Oct. 31 an exclusive option agreement for Advancium to acquire ALRN-6924, a clinical-stage oncology agent developed by Aileron prior to i...

Arctic Vision Licenses Chinese Rights for Xipere to Santen for $85 Million
Arctic Vision Licenses Chinese Rights for Xipere to Santen for $85 Million

Clearside Biomedical’s Asia-Pacific partner, Arctic Vision, announced Nov. 7 that it had licensed Chinese commercialization rights for ARVN001, marketed in the US as Xipere, to Santen Pharmaceutica...

US FDA Grants Fast Track Designation to Feliqs’ ROP Candidate
US FDA Grants Fast Track Designation to Feliqs’ ROP Candidate

Japanese biopharmaceutical company Feliqs announced Nov. 1 that the US FDA had granted its lead asset, FLQ-101, fast track designation for the prevention of retinopathy of prematurity (ROP). FLQ-10...

Zeiss Bolsters Launch of Micor 700 at AAO Meeting With US Surgeons Discussing Adoption
Zeiss Bolsters Launch of Micor 700 at AAO Meeting With US Surgeons Discussing Adoption

Carl Zeiss Meditec featured its Micor 700 at the 2024 meeting of the American Academy of Ophthalmology in Chicago, Illinois, with presentations that included booth talks by select US surgeons who h...

Ophthalmology Continues to Draw Investors, Eyecelerator Meeting Shows; Retina Stands Out
Ophthalmology Continues to Draw Investors, Eyecelerator Meeting Shows; Retina Stands Out

Ophthalmology remains an appealing investment, driven largely by procedural growth. While hundreds of companies are working toward technology enhancements and innovative therapies, ophthalmology pr...

Preliminary Results Show Prima Implant Allows for Functional Vision in Advanced GA Patients
Preliminary Results Show Prima Implant Allows for Functional Vision in Advanced GA Patients

Science Corporation, of Alameda, California, reported Oct. 22 preliminary results that showed its Prima retinal implant allowed for functional vision in patients who had lost their central visual f...

ARPA-H Seeks Proposals for Tear Duct-Based Diagnostic System, Plus Custom Dosing Platform
ARPA-H Seeks Proposals for Tear Duct-Based Diagnostic System, Plus Custom Dosing Platform

ARPA-H announced Oct. 18 that it had launched a new program to develop a tear-based biomarker measurement system that can be inserted into the tear duct to provide continuous health monitoring, pai...

US FDA Asks for Added Data on Neurotech MacTel Candidate, Delays PDUFA Date
US FDA Asks for Added Data on Neurotech MacTel Candidate, Delays PDUFA Date

Neurotech Pharmaceuticals announced Nov. 8 that it had submitted additional data requested by the US FDA to support its biologic license application (BLA) for NT-501, an encapsulated cell therapy i...

US FDA Grants De Novo Classification to LumiThera’s System for Dry AMD
US FDA Grants De Novo Classification to LumiThera’s System for Dry AMD

LumiThera announced Nov. 4 that the US FDA had granted market authorization through the de novo pathway for the Valeda photobio-modulation system for treatment of patients with dry age-related macu...

Select US FDA Approvals and Clearances in October 2024
Select US FDA Approvals and Clearances in October 2024

The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in October 2024, according to the agency’s database. Apple gained clearance for its Digital Prism ...

US FDA Accepts NDA For Lenz’ Presbyopia Drop Candidate
US FDA Accepts NDA For Lenz’ Presbyopia Drop Candidate

Lenz Therapeutics announced Oct. 21 that the US FDA had accepted its new drug application (NDA) for LNZ100, a once-daily, preservative-free eye drop candidate for presbyopia. The FDA assigned a Pre...

EyePoint Leads Latest Ophthalmic Fundraising with $161 Million Public Offering
EyePoint Leads Latest Ophthalmic Fundraising with $161 Million Public Offering

EyePoint Pharmaceuticals led recent ophthalmic fundraising efforts with a $161 million upsized underwritten public offering. Proceeds in part will fund clinical development of Duravyu. Financing an...

AI Discussions Surge at Eye Meetings with Aim to Allay Fears, Seek Use Cases
AI Discussions Surge at Eye Meetings with Aim to Allay Fears, Seek Use Cases

The explosive growth of artificial intelligence has generated both fear and excitement among many in the ophthalmic industry. As technology progresses, so do the conversations at major meetings, wi...

Office-Based Surgery Garners Enthusiasm at 2024 AAO Meeting
Office-Based Surgery Garners Enthusiasm at 2024 AAO Meeting

Several sessions at the 2024 American Academy of Ophthalmology meeting highlighted the trend of office-based surgery (OBS) and the option of oral sedation among practitioners. The consensus among t...

AAO Puts FDA Deputy Director of Ophthalmology on the Hot Seat
AAO Puts FDA Deputy Director of Ophthalmology on the Hot Seat

William Boyd, MD, deputy director of ophthalmology at the US FDA’s Office of New Drugs, had a quick answer when asked to name the biggest unmet need in ophthalmology. “We need and want more therapi...

The New Opus Genetics Charts a Course to Gene Therapy Approval
The New Opus Genetics Charts a Course to Gene Therapy Approval

Ben Yerxa, PhD, and George Magrath, MD, say they have a way out of the jungle in which ocular gene therapy development has been trapped since the US FDA approved Luxturna in 2017. “You have to be r...

Are Drugs for GA in the ‘Trough of Disillusionment’?
Are Drugs for GA in the ‘Trough of Disillusionment’?

The celebrations and excitement that accompanied the launch in 2023 of the first two drugs approved in the US for the treatment geographic atrophy (GA) gave way to a hangover and regrets at the 202...

Weighing the Ophthalmic Impact of Boom in GLP-1 Receptor Agonist Treatment
Weighing the Ophthalmic Impact of Boom in GLP-1 Receptor Agonist Treatment

Recent studies indicate that up to 6 percent of the US population is currently taking a GLP-1 receptor agonist, a class of drugs prescribed to help manage blood glucose levels for diabetes and weig...

New Trifocal IOLs Expected to Help the US Resume PC-IOL Growth
New Trifocal IOLs Expected to Help the US Resume PC-IOL Growth

Bausch + Lomb’s enVista Envy and J&J Vision’s Odyssey are two new trifocal IOLs that were shown at the 2024 AAO meeting in Chicago. They are expected to help reverse the decline in trifocal IOL sal...

AAO and Eyecelerator Sessions Showcase Latest in Glaucoma Lasers and Surgical Devices
AAO and Eyecelerator Sessions Showcase Latest in Glaucoma Lasers and Surgical Devices

New glaucoma lasers and surgical devices were shown at various venues during the 2024 AAO meeting, including Glaucoma Subspecialty Day and the Eyecelerator meeting. There was also an important upda...

Alcon Looks to Refine Retinal Surgery with Unifeye, Unipexy
Alcon Looks to Refine Retinal Surgery with Unifeye, Unipexy

Alcon launched at the 2024 AAO meeting two new retinal surgical devices—Unifeye for air-gas exchange and Unipexy for retinopexy. Each is a one-person, hand-held, single-use gas delivery device. The...

Cornea and Eye Banking Forum Looks at Ways to Expand the Donor Pool
Cornea and Eye Banking Forum Looks at Ways to Expand the Donor Pool

Expanding the donor pool was once again top of mind at the 2024 Cornea and Eye Banking Forum, held Oct. 18 in conjunction with the AAO meeting in Chicago, Illinois. The forum, supported by the Eye ...

AAO and Eyenuk Collaborate on AI-Driven DR Screening for Underserved Patients
AAO and Eyenuk Collaborate on AI-Driven DR Screening for Underserved Patients

Eyenuk and the American Academy of Ophthalmology (AAO) reported Oct. 16 that they had teamed up under the AAO’s EyeCare America program to provide eye disease screening for underserved communities ...

2025-2026 Ophthalmic Meetings Calendar
2025-2026 Ophthalmic Meetings Calendar

Market Scope regularly updates its list of ophthalmic meetings to keep the information current. Please contact us at matthewdouty@market-scope.com if we do not have your meeting listed. Thank you.

Private Practices Key to US Premium Cataract Surgery Market Dominance
Private Practices Key to US Premium Cataract Surgery Market Dominance

The US represents only 5 percent of the global population in 2024, but it accounts for nearly 36 percent of the world’s premium cataract surgery (PCS) market revenue. The US has the latest premium ...

Haag-Streit’s Metis Poised to Join Innovation-Rich and Growing Advanced Microscopes Segment
Haag-Streit’s Metis Poised to Join Innovation-Rich and Growing Advanced Microscopes Segment

Haag-Streit revealed its new Metis microscope at the 2024 European Society of Cataract and Refractive Surgeons (ESCRS) meeting and showcased it again at the 2024 AAO meeting. The Metis is specifica...

Clinical Trial Updates for Ophthalmic Candidates, November 2024
Clinical Trial Updates for Ophthalmic Candidates, November 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

NovaBay Accepts Higher Offer from PRN to Purchase Assets
NovaBay Accepts Higher Offer from PRN to Purchase Assets

NovaBay reported Nov. 6 that it had accepted a higher offer from PRN Physician Recommended Nutriceuticals, LLC, which revised its bid for NovaBay’s Avenova product line after a competing overture f...

Pine Stops Compounding IVT Avastin, Creating Concerns Over Shortage
Pine Stops Compounding IVT Avastin, Creating Concerns Over Shortage

Pine Pharmaceuticals, of Tonawanda, New York, stopped repackaging Avastin (bevacizumab) for ophthalmic use in October 2024, according to the American Academy of Ophthalmology and American Society o...

Emerging Companies Pursuing Ophthalmic Indications, November 2024
Emerging Companies Pursuing Ophthalmic Indications, November 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

November 2024 Ophthalmic News Briefs
November 2024 Ophthalmic News Briefs

Heidelberg Engineering announced Oct. 14 that the US FDA had granted 510(k) clearance to its Flex Module for the Spectralis diagnostic imaging platform. The Flex Module mounts the Spectralis to a m...

Michelle Tarver, MD, PhD, an Ophthalmologist, Named Director of FDA’s CDRH
Michelle Tarver, MD, PhD, an Ophthalmologist, Named Director of FDA’s CDRH

Michelle E. Tarver, MD, PhD, has been named director of the FDA’s Center for Devices and Radiological Health (CDRH), after serving as acting director since July 2024. She is a board-certified ophth...

Weekly Poll of Surgeons and Eye Doctors, November 2024
Weekly Poll of Surgeons and Eye Doctors, November 2024

US FDA Grants De Novo Classification to LumiThera’s Photobiomodulation System for Dry AMD
US FDA Grants De Novo Classification to LumiThera’s Photobiomodulation System for Dry AMD

LumiThera announced Nov. 4 that the US FDA had granted market authorization through the de novo pathway for the Valeda photobiomodulation system for treatment of patients with dry age-related macul...

Q3-2024 Ophthalmic Revenue Roundup for AbbVie, Apellis, Glaukos, STAAR, and Lensar
Q3-2024 Ophthalmic Revenue Roundup for AbbVie, Apellis, Glaukos, STAAR, and Lensar

AbbVie, of North Chicago, Illinois, reported Oct. 30 that its Q3-2024 eye care net revenue was $525 million, a 13.5 percent decline (-11.2 percent cc) from $605 million in Q3-2023. Restasis revenue...

NovaBay Accepts Higher Offer from PRN to Purchase Assets
NovaBay Accepts Higher Offer from PRN to Purchase Assets

NovaBay reported Nov. 6 that it had accepted a higher offer from PRN Physician Recommended Nutriceuticals, LLC, which revised its bid for NovaBay’s Avenova product line after a competing overture f...

US FDA Asks for Added Data on Neurotech MacTel Candidate, Pushes Back PDUFA Date
US FDA Asks for Added Data on Neurotech MacTel Candidate, Pushes Back PDUFA Date

Neurotech Pharmaceuticals announced Nov. 8 that it had submitted additional data requested by the US FDA to support its biologic license application (BLA) for NT-501, an encapsulated cell therapy i...

US FDA Gives Green Light to Phase I Trial of HuidaGene’s CRISPR RNA-Editing Candidate for Wet AMD
US FDA Gives Green Light to Phase I Trial of HuidaGene’s CRISPR RNA-Editing Candidate for Wet AMD

HuidaGene Therapeutics announced Nov. 4 that the US FDA had cleared its investigational new drug (IND) application for a Phase I trial of HG202, a gene therapy candidate targeting wet age-related m...

DÁVI Licenses Clobetasol Propionate Post-op Drops from Formosa for Portugal
DÁVI Licenses Clobetasol Propionate Post-op Drops from Formosa for Portugal

Taiwan-based Formosa Pharmaceuticals announced Oct. 31 that it had entered into an exclusive licensing agreement with DÁVI Farmacêutica, of Portugal, for the rights there to market clobetasol propi...

Tarsus Appoints Elizabeth Yeu, MD, as Chief Medical Officer
Tarsus Appoints Elizabeth Yeu, MD, as Chief Medical Officer

Tarsus Pharmaceuticals, maker of Xdemvy for Demodex blepharitis, announced Nov. 5 that it had appointed Elizabeth Yeu, MD, as chief medical officer. Yeu had served as Tarsus’ chief medical advisor ...

Astellas Withdraws EU Marketing Application for Avacincaptad Pegol in GA
Astellas Withdraws EU Marketing Application for Avacincaptad Pegol in GA

Japan’s Astellas Pharma announced Oct. 28 that it had withdrawn its marketing authorization application in the EU for avacincaptad pegol, a complement-5 inhibitor targeting geographic atrophy (GA) ...

Q3-2024 Ophthalmic Revenue Roundup for Regeneron, Bausch + Lomb, and Novartis
Q3-2024 Ophthalmic Revenue Roundup for Regeneron, Bausch + Lomb, and Novartis

Regeneron of Tarrytown, New York, reported Oct. 31 that its Q3-2024 US revenue for Eylea (aflibercept) 2 mg and Eylea HD (a higher dose of aflibercept at 8 mg) was $1.54 billion, a 3 percent increa...

Vabysmo Improved Vision in Underrepresented Populations with DME in Elevatum Study
Vabysmo Improved Vision in Underrepresented Populations with DME in Elevatum Study

Genentech, a member of the Roche Group, announced Oct. 18 positive topline one-year results from the postmarket Elevatum study evaluating Vabysmo (faricimab-svoa) for the treatment of diabetic macu...

Michelle Tarver, MD, PhD, an Ophthalmologist, Named Director of FDA’s CDRH
Michelle Tarver, MD, PhD, an Ophthalmologist, Named Director of FDA’s CDRH

Michelle E. Tarver, MD, PhD, has been named director of the FDA’s Center for Devices and Radiological Health (CDRH), after serving as acting director since July 2024. She is a board-certified ophth...

NovaBay Receives Higher Asset Purchase Bid from RVL-Affiliated Company
NovaBay Receives Higher Asset Purchase Bid from RVL-Affiliated Company

NovaBay reported Oct. 29 that it had received a better offer for its assets than the one it had accepted from PRN Physician Recommended Nutriceuticals, LLC. NovaBay’s board determined that the unso...

Alkeus’ Oral Gildeuretinol for GA Shows Positive Topline Results in Phase III
Alkeus’ Oral Gildeuretinol for GA Shows Positive Topline Results in Phase III

Alkeus Pharmaceuticals reported positive topline results on Oct. 23 from the Phase III SAGA trial of gildeuretinol acetate (ALK-001), a once-daily oral therapy candidate targeting geographic atroph...

RevOpsis Awarded $1.8 Million NEI Grant to Advance Retinal Candidate RO-104
RevOpsis Awarded $1.8 Million NEI Grant to Advance Retinal Candidate RO-104

RevOpsis Therapeutics announced Oct. 15 that it had been awarded a Small Business Innovation Research grant of $1.8 million from the National Eye Institute (NEI) to advance lead asset RO-104 for ex...

Korean Companies GC Biopharma, Novelty Nobility to Collaborate on GA Drug Discovery
Korean Companies GC Biopharma, Novelty Nobility to Collaborate on GA Drug Discovery

South Korean companies GC Biopharma and Novelty Nobility announced Oct. 28 that they would jointly research and develop a novel treatment candidate for geographic atrophy (GA). The companies said a...

Pine Pharmaceuticals Stops Compounding IVT Avastin, Creating Concerns Over Shortage
Pine Pharmaceuticals Stops Compounding IVT Avastin, Creating Concerns Over Shortage

Pine Pharmaceuticals, of Tonawanda, New York, stopped repackaging Avastin (bevacizumab) for ophthalmic use in October 2024, according to the American Academy of Ophthalmology and American Society o...

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