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$Nidek Launches the Phantom Open-Field Refraction System$

Nidek Launches the Phantom Open-Field Refraction System

Japanese company Nidek reported Jan. 26 that it had launched the Phantom Open-Field Refractive System. An open-field system eliminates the traditional phoropter in front of the patient; instead, vi...

US FDA Gives Green Light to Phase II Trial of Novaliq’s Topical Uveitis Candidate

Germany’s Novaliq reported on Jan. 26 that the US FDA had signed off on its investigational new drug (IND) application, allowing the company to proceed with a Phase II trial of NOV05, its topical, ...

US FDA Authorizes Compassionate Use of Urcosimod for Neuropathic Corneal Pain

London’s Okyo Pharma announced Jan. 23 that the US FDA had authorized a compassionate-use request for a single patient with severe neuropathic corneal pain to be treated with urcosimod (0.05%). The...

Emmecell Appoints Ramin Valian as Chief Executive Officer

Emmecell announced Jan. 16 that it had appointed ophthalmic industry veteran Ramin Valian as chief executive officer. Valian spent more than 20 years in top roles at Allergan and AbbVie, where he d...

2026-2027 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.

J&J Vision Reports 2025 Surgical Vision Revenue of $1.6 Billion

Johnson & Johnson reported Jan. 21 that its full year 2025 global surgical vision revenue was $1.6 billion, a 10.2 percent increase over $1.4 billion in 2024. Revenue was up 6.1 percent in the US a...

Rayner Launches Sophi Phaco Machine in the US

UK-based Rayner reported Jan. 14 that it was launching its Sophi phacoemulsification system in the US. The unit, whose name is short for Swiss ophthalmology innovation, was developed by Swiss firm ...

Eylea 8 mg Gains EU Approval to Treat Macular Edema Following RVO

German drugmaker Bayer announced Jan. 16 that the European Commission had approved Eylea 8 mg, known as Eylea HD in the US, to treat patients with visual impairment due to macular edema following r...

Venture Capital in Ophthalmology Doubled in 2025 to Just Under $2 Billion

Venture capital investment in ophthalmology more than doubled from 2024 to 2025, totaling just under $2 billion in 2025 compared to $934.1 million in 2024. 2025 saw $1.1 billion in early-stage fund...

BioAge Enters Ophthalmology with Oral NLRP3 Inhibitor Candidate for DME

BioAge Labs announced Jan. 20 that it would expand development of BGE-102, an orally administered NLRP3 inhibitor, into ophthalmology with a proof-of-concept study in diabetic macular edema (DME). ...

BioTissue Sells Non-ophthalmic Surgical and Wound Care Business to BioStem

BioTissue Holdings reported Jan. 21 that it had sold its non-ocular surgical and wound care business to BioStem Technologies for an upfront cash payment of about $15 million, plus potential milesto...

Three New Prescription Drugs Reshape the US Dry Eye Pharmaceutical Market, According to Market Scope

Three recently launched prescription therapies are rapidly redefining the competitive landscape of the US dry eye pharmaceutical market and are expected to drive significant revenue growth over the...

Nanoscope’s MCO-010 Gains Sakigake (Pioneer) and Orphan Drug Status in Japan

Nanoscope Therapeutics announced Jan. 20 that Japan’s Ministry of Health, Labour, and Welfare had granted Sakigake (Pioneer) and orphan drug designations to MCO-010 across inherited retinal disease...

BVI Medical Appoints Jim Hollingshead, PhD, as President and CEO

BVI Medical announced Jan. 19 that it had appointed Jim Hollingshead, PhD, as president and chief executive officer. Hollingshead succeeds Shervin Korangy, who will continue to serve as an advisor ...

2025 in Review: STAAR Calls Off Alcon Acquisition Deal after Failed Vote by Shareholders

STAAR Surgical’s termination this month of its acquisition agreement with Alcon ended a five-month saga that pivoted on how the ophthalmic industry should valuate the world’s leading phakic IOL mak...

Ocular Therapeutix Takes Cue from FDA, Will Submit NDA for Axpaxli After Single Phase III Trial

Ocular Therapeutix announced Dec. 8 that it planned to submit a new drug application (NDA) to the US FDA for Axpaxli in wet age-related macular degeneration (AMD) if it sees positive one-year data ...

VivaVision Needs Single US Phase III Trial for Uveitis NDA, FDA Says

VivaVision Biotech reported Jan. 6 that minutes from its meeting with the US FDA confirm that its ongoing Phase III study in China can serve as one of the two pivotal trials required to support a U...

Select US FDA Approvals and Clearances in December 2025

The US FDA’s ophthalmic device division granted clearance to three devices using the 510(k) pathway in December 2025, according to the agency’s database. Remidio received clearance for its Fundus O...

Argenx Pulls Plug on Thyroid Eye Disease Program on Recommendation of Data Monitors

Dutch drugmaker Argenx reported Dec. 15 that it would discontinue the Phase III program for subcutaneous efgartigimod in moderate to severe thyroid eye disease (TED). An independent data monitoring...

US FDA Rejects Outlook’s Lytenava for a Third Time, Citing Lack of Efficacy

Outlook Therapeutics reported Dec. 31 that the US FDA had issued a third complete response letter rejecting the company’s biologics license application (BLA) for Lytenava, an ophthalmic formulation...

Meet with Market Scope at the 2026 Glaucoma 360 Meeting

Market Scope will be presenting industry data at the 2026 Glaucoma 360 meeting, set for Jan. 29-31 in San Francisco. Contact us to set up a time to discuss your custom research needs. Reach us at 3...

PDUFA Dates for Ophthalmic Drug Candidates, January 2026

The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.

US FDA Extends Action Date on Aldeyra’s Reproxalap to March 2026

Aldeyra Therapeutics reported Dec. 15 that the US FDA had extended the Prescription Drug User Fee Act (PDUFA) target action date for dry eye drop candidate reproxalap to March 16, 2026. The company...

Lenz Signs Deal with Lunatus for Marketing of Vizz in Middle East

Lenz Therapeutics announced Jan. 5 an exclusive distribution agreement for Dubai’s Lunatus to develop and commercialize the presbyopia drop Vizz in the Middle East region. Under the deal, Lenz, of ...

2025 in Review: Corporate and Surgeon Rankings of Top 10 Stories

Market Scope asked industry participants and surgeons to select the top story for 2025. Below are their choices. STAAR Calls Off Alcon Acquisition Deal after Failed Vote by Shareholders Turmoil Rei...

2025 in Review: Turmoil Reigns at US FDA, with Leadership Shuffling and High-Level Exits

A year of upheaval at the US FDA began with what amounted to a gag order on staffers from President Donald Trump and ended with the fifth person in a year taking charge of the agency’s drug evaluat...

2025 in Review: Bausch + Lomb Bounces Back from IOL Recall, Plans Busy Launch Schedule

Bausch + Lomb turned around a global recall of its enVista intraocular lenses (IOLs) in under a month in the spring of 2025, after facing a worst-case scenario for any medical device manufacturer: ...

2025 in Review: Alcon Launches Two New Platforms, Unity and Voyager

Ophthalmic industry leader Alcon launched the Unity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS) in April 2025. The devices are designed to replace Alcon’s Constellation dual-...

$2025 in Review: US Refractive Surgery Volumes Hit Record Low Amid Economic Funk$

2025 in Review: US Refractive Surgery Volumes Hit Record Low Amid Economic Funk

Global refractive surgeries have declined in recent years, but the US refractive surgery market has experienced a sharper drop since 2021. The US economy underwent a plethora of challenges in 2025,...

2025 in Review: Sydnexis’ Atropine Drop for Myopia Rejected in US, Approved Elsewhere

The US FDA’s decision in October 2025 to reject Sydnexis’ low-dose atropine drop for myopia touched off an abundance of discussion among eye care providers—many of whom have used compounded low-dos...

2025 in Review: EssilorLuxottica Entrenches Ophthalmic Strategy with 2025 Deals

EssilorLuxottica reported Dec. 12 that it had acquired Signifeye, a network of 15 eye centers and clinics in the Flanders region of Belgium. The transaction is expected to close by Q1-2026. No fina...

2025 in Review: Multiple Cornea Therapeutic Milestones Achieved in Late 2025

The fourth quarter of 2025 saw multiple breakthroughs in cornea transplant therapies and corneal crosslinking. In October, the US FDA approved Epioxa, an epi-on version of Glaukos’ iLink corneal cr...

2025 in Review: Next-Generation PC-IOL Designs Drive Global Market Expansion in 2025

Global demand in 2025 for presbyopia-correcting intraocular lenses (PC-IOLs) increased meaningfully, driven by improved optical performance, broader participation by leading IOL manufacturers, decl...

2025 in Review: Encelto for MacTel Nabs Many Firsts, Opens New Area of Study

US FDA approval of Encelto in March 2025 handed Neurotech a cluster of firsts. It was the first therapy approved to treat macular telangiectasia type 2 (MacTel), the first encapsulated cell therapy...

Virtual Retina Could Help Unlock New Treatments for Vision Loss

New computer modeling could help scientists better understand how the retina regenerates, opening the door to new treatments for vision loss, researchers from the UK’s University of Surrey say. The...

Clinical Trial Updates for Ophthalmic Candidates , January 2026

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

Alvotech, Teva Reach Deal with Regeneron to Bring Eylea Biosimilar to US No Later than H2-2026

Alvotech and Teva reported Dec. 19 that they had reached a settlement and license agreement with Regeneron that clears the way for Teva to commercialize AVT06, a biosimilar to Eylea, in the US, if ...

Weekly Poll of MDs, US and Western Europe, January 2026

Kodiak Leads Latest Ophthalmic Fundraising with $184 Million Offering

Kodiak Sciences led recent ophthalmic fundraising efforts with a $184 million public offering to advance its Phase III candidates for retinal disease. Financing announced in the past four weeks tot...

January 2026 Ophthalmic News Briefs

Italy-based NTC reported Dec. 10 that it had completed its acquisition of Pharmathen’s ophthalmology business. No financial details were provided. NTC said the move gives it a global portfolio of g...

STAAR Agrees to Leadership Changes Following Failed Acquisition Attempt

STAAR Surgical and Broadwood Partners reported Jan. 15 that STAAR had agreed to several leadership changes, as the phakic IOL maker moves forward from a shareholder revolt that ended Alcon’s attemp...

Formosa Licenses Clobetasol Drops to Samil for South Korea

Taiwan-based Formosa Pharmaceuticals announced Jan. 12 that it had agreed to license to Samil Pharmaceuticals exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical infla...

Topcon Healthcare Partners with RemoniHealth for Remote Eye Screening

Topcon Healthcare announced Jan. 13 a commercial partnership with RemoniHealth, of White Plains, New York, which provides remote monitoring of eye disease. No financial details were disclosed. Remo...

US FDA Gives Green Light to Trial of Allotex’ Tissue Implant for Presbyopia

Allotex announced Jan. 8 that the US FDA had signed off on its investigational device exemption (IDE) submission, allowing the company to proceed with a trial of Allo-1, its tissue implant technolo...

Ikarovec Signs Option to License IVT Capsid Technology for Use with AMD Gene Therapy

UK-based Ikarovec reported Jan. 6 that it had signed an option agreement for a worldwide license of VectorBuilder’s novel capsid technology for use with IKAR-003, Ikarovec’s gene therapy candidate ...

Bio Usawa Gains Approval for Lucentis Biosimilar in Rwanda, Ghana

African biotech company Bio Usawa announced Jan. 13 that its Lucentis (ranibizumab) biosimilar had received marketing approval in Ghana under the brand name BioUcenta. The company said the approval...

GenSight Gains Compassionate Use Authorization for Lumevoq in France and Israel

GenSight Biologics reported in December 2025 that regulators in France and Israel had granted early access for compassionate use to Lumevoq, the company’s intravitreal gene therapy candidate for Le...

Nanodropper, Now Mu Medical, Plans Combination with Bedo and Viseon

Nanodropper, of Rochester, Minnesota, announced Jan. 9 that it was now operating as Mu Medical and planned to combine with Bedo Solutions and Viseon Labs under the new umbrella. Nanodropper was fou...

US FDA Grants Fast Track Status to Complement’s GA Gene Therapy Candidate

Complement Therapeutics announced Jan. 8 that the US FDA had granted fast track designation to CTx001, a gene therapy candidate targeting geographic atrophy (GA). Fast track status is intended to f...

STAAR Surgical Calls Off Alcon Acquisition Deal after Failed Shareholder Vote

STAAR Surgical reported Jan. 6 that it intended to terminate its acquisition agreement with Alcon, with no termination fee payable by either party. The announcement came minutes after the start of ...

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