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Alcon Agrees to Buy Lensar in Deal Worth up to $430 Million
Alcon Agrees to Buy Lensar in Deal Worth up to $430 Million

Alcon announced March 24 that it had entered into a definitive agreement to acquire Lensar, including its Ally femtosecond laser cataract system, its Streamline software, and the Lensar legacy lase...

Alcon Introduces Clareon PanOptix Pro IOL
Alcon Introduces Clareon PanOptix Pro IOL

Alcon on April 2 introduced its Clareon PanOptix Pro trifocal IOL, a next-generation version of its groundbreaking PanOptix model. The company said the lens had been made available to select US pra...

US FDA Again Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for Yet Another Symptom Trial
US FDA Again Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for Yet Another Symptom Trial

Aldeyra Therapeutics reported April 3 that the US FDA had once again issued a complete response letter rejecting the company’s new drug application (NDA) for topical reproxalap as a treatment for d...

Orasis Launches Qlosi Presbyopia Drops in US
Orasis Launches Qlosi Presbyopia Drops in US

Orasis Pharmaceuticals announced April 7 that Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% eye drops for the treatment of presbyopia are now available to prescribe in the US. Orasis s...

Select US FDA Approvals and Clearances in March 2025
Select US FDA Approvals and Clearances in March 2025

There was one US FDA clearance through the ophthalmic device division using the 510(k) pathway in March 2025, according to the agency’s database. CenterVue gained approval for its Maia scanning las...

Nordic Pharma Secures CE Marking for Lacrifill Canalicular Gel in Dry Eye
Nordic Pharma Secures CE Marking for Lacrifill Canalicular Gel in Dry Eye

Nordic Group B.V., a Dutch affiliate of Nordic Pharma, announced April 7 that Lacrifill canalicular gel had received CE marking in Europe for the treatment of dry eye. Lacrifill is a cross-linked h...

PDUFA Dates for Ophthalmic Drug Candidates, April 2025
PDUFA Dates for Ophthalmic Drug Candidates, April 2025

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 Accepts Outlook’s Resubmitted BLA for Lytenava, Sets PDUFA Date of Aug. 27
US FDA Accepts Outlook’s Resubmitted BLA for Lytenava, Sets PDUFA Date of Aug. 27

Outlook Therapeutics announced April 8 that the US FDA had accepted the resubmitted biologics license application (BLA) for ONS-5010 (bevacizumab-vikg, Lytenava), an ophthalmic formulation of bevac...

Atsena Leads Latest Ophthalmic Fundraising with $150 Million in Series C
Atsena Leads Latest Ophthalmic Fundraising with $150 Million in Series C

Atsena Therapeutics led recent ophthalmic fundraising efforts with $150 million in Series C funding, led by new investor Bain Capital, to advance its gene therapy candidates. Financing announced in...

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.

Delegates Debate Best Options to Combat Asia’s Pediatric Myopia Epidemic
Delegates Debate Best Options to Combat Asia’s Pediatric Myopia Epidemic

The treatment of myopia progression with low-concentration atropine (LCA) drops was the most discussed intervention for the disease among delegates at the 2025 APAO-AIOS meeting. Globally, more tha...

Indian Glaucoma Surgeons Embrace MIGS Procedures Over Devices
Indian Glaucoma Surgeons Embrace MIGS Procedures Over Devices

Most MIGS (minimally invasive glaucoma surgery) sessions at major ophthalmic meetings talk about devices. Indian doctors at the MIGS sessions of the joint APAO-AIOS congress in April mostly talked ...

Malvina Eydelman, MD, Named CEO of CCOI Organization
Malvina Eydelman, MD, Named CEO of CCOI Organization

Longtime US FDA regulator and board-certified ophthalmologist Malvina Eydelman, MD, has stepped into a new role as chief executive officer of the Collaborative Community on Ophthalmic Innovation (C...

Retina Pharma and Premium IOLs Continue to Drive Ophthalmic Market
Retina Pharma and Premium IOLs Continue to Drive Ophthalmic Market

The ophthalmology industry produced an estimated $48.8 billion in revenue in 2024, with an expected compound annual growth rate (CAGR) of 4.5 percent. Market Scope estimates the industry will reach...

Opthea Discontinues Wet AMD Program After Second Phase III Trial Misses Endpoint
Opthea Discontinues Wet AMD Program After Second Phase III Trial Misses Endpoint

Opthea announced March 31 its decision to discontinue development of sozinibercept (OPT-302) in wet age-related macular degeneration (AMD) after a second Phase III trial missed its primary endpoint...

Clinical Trial Updates for Ophthalmic Candidates, April 2025
Clinical Trial Updates for Ophthalmic Candidates, April 2025

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

Job and Funding Cuts in US HHS Department Hit Ophthalmic Community
Job and Funding Cuts in US HHS Department Hit Ophthalmic Community

The Trump administration’s overhaul of the US Health and Human Services Department (HHS) through mass firings, funding cuts, and restructuring continues to affect those working to protect vision. J...

Alcon Announces Majority Ownership of Aurion Cell Therapy Company
Alcon Announces Majority Ownership of Aurion Cell Therapy Company

Alcon announced March 26 that it had acquired a majority interest in Aurion Biotech, developer of a corneal cell therapy. News of Alcon’s majority stake—after acquiring additional shares in Aurion ...

Bausch + Lomb Recalls Certain enVista IOLs Amid Reports of TASS Cases
Bausch + Lomb Recalls Certain enVista IOLs Amid Reports of TASS Cases

Bausch + Lomb announced March 27 that it was voluntarily recalling certain intraocular lenses (IOLs) on its enVista platform. A letter to customers from Bausch + Lomb Chairman and CEO Brent Saunder...

US FDA Plans to Phase Out Animal Testing for Biologics, Drugs
US FDA Plans to Phase Out Animal Testing for Biologics, Drugs

The US FDA reported April 10 that it planned to phase out animal testing as part of the approval process for biologics and drugs, as the agency moves to more effective, human-relevant methods, call...

Topcon to Go Private Through Tender Offer by KKR and JIC Capital
Topcon to Go Private Through Tender Offer by KKR and JIC Capital

Publicly held Topcon plans to go private under a $2.3 billion tender offer by private equity firm KKR, headquartered in New York, and JIC Capital, the private equity arm of Japan’s government-owned...

Emerging Companies Pursuing Ophthalmic Indications, April 2025
Emerging Companies Pursuing Ophthalmic Indications, April 2025

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

Biocon’s Deal with Regeneron Will Bring Yesafili to Market in US No Later than H2-2026
Biocon’s Deal with Regeneron Will Bring Yesafili to Market in US No Later than H2-2026

India’s Biocon Biologics reported April 15 that it had reached a settlement and license agreement with Regeneron that clears the way for Biocon to commercialize Yesafili, a biosimilar to Eylea, in ...

Thomas Panek Becomes President, CEO of Lighthouse Guild
Thomas Panek Becomes President, CEO of Lighthouse Guild

Lighthouse Guild announced March 18 that it had appointed Thomas Panek as its new president and CEO, effective April 1. Panek replaced Calvin Roberts, MD, who had led the nonprofit since April 2020...

Weekly Surgeon Poll, April 2025
Weekly Surgeon Poll, April 2025

April 2025 Ophthalmic News Briefs
April 2025 Ophthalmic News Briefs

Carl Zeiss Meditec announced March 21 the availability in Canada of the Visulas Combi, a green and YAG ophthalmic laser workstation combining photodisruption, photocoagulation, and slit lamp techno...

Biocon Reaches Settlement, License Agreement with Regeneron to Bring Yesafili to Market in US
Biocon Reaches Settlement, License Agreement with Regeneron to Bring Yesafili to Market in US

India’s Biocon Biologics reported April 15 that it had reached a settlement and license agreement with Regeneron that clears the way for Biocon to commercialize Yesafili, a biosimilar to Eylea, in ...

US FDA Grants 510(k) Clearance to BVI’s Laser Endoscopy System for Glaucoma
US FDA Grants 510(k) Clearance to BVI’s Laser Endoscopy System for Glaucoma

BVI Medical announced April 17 that it had received US FDA 510(k) clearance for its Leos laser endoscopy system for glaucoma. The company said Leos offers a more intuitive, minimally invasive ab in...

Sanoculis Receives CE Marking for MINT Procedure for Glaucoma
Sanoculis Receives CE Marking for MINT Procedure for Glaucoma

Israel’s Sanoculis announced April 17 that it had received CE marking in the EU for its MINT (minimally invasive nasal trabeculostomy) procedure for adults with glaucoma. MINT features a mechanical...

J&J Vision Reports Q1-2025 Surgical Revenue of $361 Million
J&J Vision Reports Q1-2025 Surgical Revenue of $361 Million

J&J Vision’s Q1-2025 global surgical revenue totaled $361 million, a 3.7 percent increase (+6.2 percent cc) over $348 million in Q1-2024, parent Johnson & Johnson, of New Brunswick, New Jersey, rep...

Cambridge Innovation Institute Absorbs Healthegy’s OIS, OIS Retina Conferences
Cambridge Innovation Institute Absorbs Healthegy’s OIS, OIS Retina Conferences

Cambridge Innovation Institute, of Needham, Massachusetts, announced April 10 that it would expand its health care event calendar by taking on Healthegy’s ophthalmic conferences—the Ophthalmology I...

US FDA Plans to Phase Out Animal Testing for Biologics, Drugs
US FDA Plans to Phase Out Animal Testing for Biologics, Drugs

The US FDA reported April 10 that it planned to phase out animal testing as part of the approval process for biologics and drugs, as the agency moves to more effective, human-relevant methods, call...

ACRO Biomedical Gains Regulatory Approval in Taiwan for Corneal Xenograft
ACRO Biomedical Gains Regulatory Approval in Taiwan for Corneal Xenograft

Taiwan’s ACRO Biomedical announced April 13 that the country’s Ministry of Health and Welfare had granted regulatory approval to ACRO’s ABCcolla decellularized porcine collagen corneal xenograft. A...

Opthea Will Lay Off 65 Percent of Employees after Phase III Wet AMD Failures
Opthea Will Lay Off 65 Percent of Employees after Phase III Wet AMD Failures

Opthea plans to lay off about 65 percent of its workforce, effective May 1, the company said in a corporate update filed April 10 with the with the US Securities and Exchange Commission (SEC). The ...

US FDA Grants RMAT Status to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate
US FDA Grants RMAT Status to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate

Atsena Therapeutics announced April 15 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS...

Tenpoint Submits NDA to US FDA for Brimochol PF in Presbyopia
Tenpoint Submits NDA to US FDA for Brimochol PF in Presbyopia

Tenpoint Therapeutics announced April 8 that it had submitted a new drug application (NDA) to the US FDA for Brimochol PF, a combination eye drop candidate targeting presbyopia. In its Phase III tr...

Nordic Pharma Secures CE Marking for Lacrifill Canalicular Gel in Dry Eye
Nordic Pharma Secures CE Marking for Lacrifill Canalicular Gel in Dry Eye

Nordic Group B.V., a Dutch affiliate of Nordic Pharma, announced April 7 that Lacrifill canalicular gel had received CE marking in Europe for the treatment of dry eye. Lacrifill is a cross-linked h...

US FDA Accepts Outlook’s Resubmitted BLA for Lytenava, Sets PDUFA Date of Aug. 27
US FDA Accepts Outlook’s Resubmitted BLA for Lytenava, Sets PDUFA Date of Aug. 27

Outlook Therapeutics announced April 8 that the US FDA had accepted the resubmitted biologics license application (BLA) for ONS-5010 (bevacizumab-vikg, Lytenava), an ophthalmic formulation of bevac...

US FDA Issues Update on Bausch + Lomb enVista IOL Recall
US FDA Issues Update on Bausch + Lomb enVista IOL Recall

The US FDA issued an update April 7 with more details on Bausch + Lomb’s voluntary recall of certain intraocular lenses (IOLs) on its enVista platform. The update listed the affected lenses: —enVis...

Orasis Launches Qlosi Presbyopia Drops in US
Orasis Launches Qlosi Presbyopia Drops in US

Orasis Pharmaceuticals announced April 7 that Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% eye drops for the treatment of presbyopia are now available to prescribe in the US. Orasis s...

Chinese Regulators Approve Tapcom Fixed-Combo Glaucoma Drop from Santen
Chinese Regulators Approve Tapcom Fixed-Combo Glaucoma Drop from Santen

Japan’s Santen announced April 4 that China’s National Medical Products Administration had approved the marketing authorization application for Tapcom (tafluprost 0.0015%/timolol maleate 0.5% ), a ...

Onconetix Signs Letter of Intent for Potential Business Combination with Ocuvex
Onconetix Signs Letter of Intent for Potential Business Combination with Ocuvex

Onconetix, of Cincinnati, Ohio, announced April 8 that it had signed a non-binding letter of intent contemplating a potential business combination with Ocuvex, maker of Omlonti (omidenepag isopropy...

Opthea Discontinues Wet AMD Trials After Second Phase III Trial Misses Endpoint
Opthea Discontinues Wet AMD Trials After Second Phase III Trial Misses Endpoint

Opthea announced March 31 its decision to discontinue development of sozinibercept (OPT-302) in wet age-related macular degeneration (AMD) after a second Phase III trial missed its primary endpoint...

2024 Ophthalmic Revenue Roundup for Harrow, Astellas, Iridex, and Xbrane
2024 Ophthalmic Revenue Roundup for Harrow, Astellas, Iridex, and Xbrane

Nashville, Tennessee-based Harrow reported March 27 that its 2024 revenue was $199.6 million, a 53 percent increase over $130.2 million in 2023. The company generated record quarterly revenue in Q4...

US FDA Again Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for Yet Another Symptom Trial
US FDA Again Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for Yet Another Symptom Trial

Aldeyra Therapeutics reported April 3 that the US FDA had once again issued a complete response letter rejecting the company’s new drug application (NDA) for topical reproxalap as a treatment for d...

Malvina Eydelman, MD, Named CEO of CCOI Organization
Malvina Eydelman, MD, Named CEO of CCOI Organization

Longtime US FDA regulator and board-certified ophthalmologist Malvina Eydelman, MD, has stepped into a new role as chief executive officer of the Collaborative Community on Ophthalmic Innovation (C...

Alcon Introduces Clareon PanOptix Pro Trifocal IOL
Alcon Introduces Clareon PanOptix Pro Trifocal IOL

Alcon on April 2 introduced its Clareon PanOptix Pro trifocal IOL, a next-generation version of its groundbreaking PanOptix model. The company said the PanOptix Pro had been made available to selec...

Sydnexis Receives Positive CHMP Opinion for Low-Dose Atropine Drops in Pediatric Myopia
Sydnexis Receives Positive CHMP Opinion for Low-Dose Atropine Drops in Pediatric Myopia

Sydnexis announced April 1 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorization in the European Union for its low-dose ...

Topcon to Go Private Through Tender Offer by KKR and JIC Capital
Topcon to Go Private Through Tender Offer by KKR and JIC Capital

Publicly held Topcon plans to go private under a $2.3 billion tender offer by private equity firm KKR, headquartered in New York, and JIC Capital, the private equity arm of Japan’s government-owned...

Rayner Doubles IOL Manufacturing Capacity with Expansion of Facility
Rayner Doubles IOL Manufacturing Capacity with Expansion of Facility

Rayner announced April 2 that it had completed an expansion of its production facility in Worthing, UK, doubling the number of intraocular lenses (IOLs) it can manufacture annually to 4 million. Th...

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