Latest Industry News & Trends

Fall of Restasis Weighs on Dry Eye Revenue in 2024

Restasis continued to act as a brake on prescription dry eye pharmaceutical revenue in 2024 as its US sales kept plummeting. AbbVie reported that sales of the one-time blockbuster drug in the US fe...

Select US FDA Approvals and Clearances in November 2024

The US FDA granted one clearance through the ophthalmic device division using the 510(k) pathway in November 2024, according to the agency’s database. Novoxel, a newcomer to ophthalmology but not m...

PDUFA Dates for Ophthalmic Drug Candidates

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

Lineage Leads Latest Ophthalmic Fundraising with $66 Million Offering

Lineage Cell Therapeutics led recent ophthalmic fundraising efforts with a registered direct offering worth up to $66 million to advance its RPE cell therapy candidate. Financing announced in the p...

Weekly Surgeon Poll, December 2024

December 2024 Ophthalmic News Briefs

Dutch company Ophtec announced Nov. 18 that it had gained CE marking for its Artiplus phakic IOL. The company said the lens offered a solution for relatively young presbyopes, typically in their ea...

Harrow Lowers Price of Drugs through GoodRx Partnership, Price Cuts

Harrow, of Nashville, Tennessee reported Nov. 13 that it had entered into a partnership with GoodRx to provide patients for whom insurance is not a viable option a cash-pay alternative. Harrow prod...

US FDA Clears Tixel i Dry Eye and MGD Treatment Device from Novoxel

Israel’s Novoxel announced Nov. 19 that the US FDA had granted 510(k) clearance to the Tixel i treatment device for evaporative dry eye and meibomian gland dysfunction. The company said the device ...

Q3-2024 Ophthalmic Revenue Roundup for Immunocore, Harrow, Tarsus, Lumibird, and Ocular Therapeutix

UK-headquartered Immunocore reported Nov. 6 that its Q3-2024 net revenue from Kimmtrak (tebentafusp) was $80.2 million, a 28 percent increase over $62.6 million in Q3-2023. Regionally, Kimmtrak net...

US FDA Accepts NDA for Aldeyra’s Reproxalap in Dry Eye

Aldeyra Therapeutics announced Nov. 18 that the US FDA had accepted for review the company’s resubmitted new drug application (NDA) for topical ocular reproxalap for dry eye. The FDA assigned a Pre...

Q3-2024 Ophthalmic Revenue Roundup for Alcon, Hoya, RxSight, Sight Sciences, and Iridex

Alcon reported Nov. 12 that its Q3-2024 net sales totaled $2.4 billion, a 6 percent increase over $2.3 billion in Q3-2023. Surgical net sales for implantables, consumables, and equipment/other were...

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...

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...

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...

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 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...

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 ...

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...

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...

Grifols, BARDA Partner on Ocular Immunoglobulin Drops for Sulfur Mustard Exposure

Barcelona-basedGrifols reported Oct. 22 that it is partnering with the US government’s BARDA to test ocular surface immunoglobulin (OSIG) eye drops for their ability to treat ocular damage from sul...

Emerging Companies Pursuing Ophthalmic Indications, October 2024

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

Clinical Trial Updates for Ophthalmic Candidates, October 2024

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

October 2024 Ophthalmic News Briefs

Oculus has announced the addition of frequency doubling perimetry (FDP) to its Easyfield VR visual field diagnostic headset. The German ophthalmic diagnostic company, with US headquarters in Arling...

NovaBay to Sell Avenova Products for $9.5 Million as Part of Dissolution Plan

NovaBay Pharmaceuticals has agreed to sell its Avenova products to PRN Physician Recommended Nutriceuticals for $9.5 million in cash, the companies announced Sept. 20. The deal is expected to close...

Aldeyra Resubmits NDA for Reproxalap in Dry Eye

Aldeyra Therapeutics announced Oct. 3 that it had resubmitted its new drug application (NDA) to the US FDA for topical ocular reproxalap in dry eye. The US FDA issued a complete response letter in ...

EU Regulators Approve Vevizye from Novaliq; Théa Will Commercialize Dry Eye Drop

Germany’s Novaliq announced Oct. 2 that the European Commission had approved its dry eye treatment Vevizye (cyclosporine ophthalmic solution) 0.1%. The product is indicated for the treatment of mod...

NovaBay to Sell Avenova Products for $9.5 Million as Part of Dissolution Plan

NovaBay Pharmaceuticals has agreed to sell its Avenova products to PRNPhysician Recommended Nutriceuticals for $9.5 million in cash, the companies announced Sept. 20. The deal is expected to close ...

US FDA Warns Regener-Eyes Maker Over Plant Conditions, Unapproved Products

The US FDA has sent a warning letter to Regenerative Processing Plant in Palm Harbor, Florida, finding fault with its manufacturing processes and raising concerns that its eye drop products may sti...

Emerging Companies Pursuing Ophthalmic Indications, September 2024

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

Eyenovia Plans to Seek US FDA Clearance for Gen-2 Optejet Microdoser

Eyenovia announced in its Q2-2024 financial results that it planned to seek marketing clearance for an advanced Gen-2 Optejet microdoser. Eyenovia, of New York, said production was expected to begi...

Ocumension Acquires Rights to Alcon Eye Drops in Exchange for Equity Stake

China’s Ocumension Therapeutics announced Aug. 13 that it would acquire or secure Chinese rights to a portfolio of Alcon dry eye treatments and procedural drops. In exchange, Ocumension will issue ...

MeiraGTx Leads Latest Ophthalmic Fundraising with $50 Million Offering

MeiraGTx led recent ophthalmic fundraising efforts with a $50 million offering of ordinary shares as it moves forward with its extensive pipeline of gene therapy candidates. Financing announced in ...

Clinical Trial Updates for Ophthalmic Candidates, August 2024

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

Emerging Companies Pursuing Ophthalmic Indications, August 2024

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

USC Alums Gift Eye Care Practice to Roski Eye Institute

Richard Weise, MD, and his wife, Cathy, have gifted their ophthalmic practice, the Glendale Eye Medical Group, of Glendale, California, to the USC Roski Eye Institute, the university announced July...

Weekly Surgeon Poll, August 2024

August 2024 Ophthalmic News Briefs

Ireland-based Mallinckrodt announced Aug. 6 that its H.P. Acthar Gel single-dose prefilled SelfJect injector was available in the US. The US FDA approved the supplemental new drug application for t...

Ocumension Acquires Rights to Alcon Eye Drops in Exchange for 16.7 Percent Equity Stake

China’s Ocumension Therapeutics announced Aug. 13 that it would acquire or secure Chinese rights to a portfolio of Alcon dry eye treatments and procedural drops. In exchange, Ocumension will issue ...

Q2-2024 Ophthalmic Revenue Roundup for AbbVie, Carl Zeiss Meditec, Amgen, STAAR, Astellas, Immunocore, Tarsus, Biogen, Lensar, and Iridex

AbbVie, of North Chicago, Illinois, reported July 25 that Q2-2024 net revenue for its eye care products totaled $533 million, a 13.3 percent decline (-10.9 percent cc) from $617 million in Q2-2023....

Q2-2024 Ophthalmic Revenue Roundup for Hoya, Harrow, RxSight, Sight Sciences, Ocular Therapeutix, and EyePoint

Japan-based Hoya Corporation announced Aug. 1 that its medical care segment (IOLs, endoscopes, artificial bone) had revenue for the quarter ending June 30, 2024—the first quarter of its fiscal year...

USC Alums Gift Eye Care Practice to Roski Eye Institute

Richard Weise, MD, and his wife, Cathy, have gifted their ophthalmic practice, the Glendale Eye Medical Group, of Glendale, California, to the USC Roski Eye Institute, the university announced July...

Formosa Licenses Clobetasol Propionate Drops to Apotex for Canada

Taiwan-based Formosa Pharmaceuticals announced Aug. 5 that it had agreed to license to Apotex exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical inflammation and pain...

Q2-2024 Ophthalmic Revenue Roundup for Regeneron, Roche, Bausch + Lomb, Novartis, and Four Others

Regeneron, of Tarrytown, New York, reported Aug. 1 that its Q2-2024 US revenue for Eylea was $1.53 billion, a 2 percent increase from $1.5 billion in Q2-2023. Eylea HD accounted for $304 million of...

Novaliq Receives Positive CHMP Opinion for Vevizye in Dry Eye

Germany’s Novaliq announced July 29 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorization in the European Union for Vevi...

Eyenovia, SGN Nanopharma Will Collaborate on Chronic Dry Eye Candidate with Optejet Microdoser

Eyenovia, of New York, announced July 30 that it had entered into a collaboration agreement with SGN Nanopharma to develop SGN’s micellar nanoparticle platform-based cyclosporine formulation for us...

Bausch + Lomb Acquires Dry Eye Diagnostic Company Trukera Medical

Bausch + Lomb announced July 23 that it had acquired dry eye diagnostic company Trukera Medical from its private equity owner, AccelMed Partners, and other shareholders. No financial details were d...

Eyenovia, Senju Will Collaborate on Chronic Dry Eye Candidate with Optejet Microdoser

Eyenovia, of New York, announced July 23 that it had entered into a collaboration agreement with Japan’s Senju Pharmaceutical to develop Senju’s corneal epithelial wound healing candidate, SJP-0035...

New OTC Eye Lubricants Available from AbbVie, Ocusoft

AbbVie has introduced two new preservative-free lubricant eye drop products—Refresh Tears PF and Refresh Relieva PF Xtra. AbbVie, of North Chicago, Illinois, said the new products feature a soft-sq...

Bausch + Lomb Adds Dry Eye Supplement to Fast-Growing Consumer Segment

Bausch + Lomb is expanding its fast-growing consumer segment with the launch of a nutritional supplement to combat the signs and symptoms of dry eye. The supplement is called Blink NutriTears. The ...

Clinical Trial Updates for Ophthalmic Candidates, July 2024

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

July 2024 Ophthalmic News Briefs

Bausch + Lomb announced July 23 that it had acquired dry eye diagnostic company Trukera Medical from its private equity owner, AccelMed Partners, and other shareholders. No financial details were d...

Okyo Pharma to Initiate Phase II Trial for OK-101 in Neuropathic Corneal Pain

London’s Okyo Pharma announced July 11 that it would advance OK-101 into a Phase II clinical trial of neuropathic corneal pain (NCP). The US FDA cleared the investigational new drug (IND) applicati...

Kane Biotech Licenses Biofilm Dispersion Enzyme to I-Med for Dry Eye

Kane Biotech announced June 25 that I-Med Pharma had licensed its DispersinB biofilm dispersion technology to incorporate into its products to relieve dry eye. It’s the first commercial agreement f...

Nordic Pharma Launches Lacrifill Canalicular Gel for Dry Eye in US

Nordic Pharma announced May 29 that it had launched Lacrifill canalicular gel for dry eye in the US. Lacrifill is a cross-linked hyaluronic acid derivative intended to temporarily block tear draina...

BioTissue Introduces Shelf-Stable CAM360 AmnioGraft for Dry Eye, Other Disorders

BioTissue announced June 3 that it was launching the CAM360 AmnioGraft, a new hydrated, shelf-stable cryopreserved amniotic membrane product for mild to moderate dry eye and other ocular surface di...

Clinical Trial Updates for Ophthalmic Candidates, June 2024

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

June 2024 Ophthalmic News Briefs

Japan’s Nidek announced June 3 that it had launched the RS-1 Glauvas OCT system. The device is CE marked as a Class IIa device. Nidek said the RS-1 Glauvas’ streamlined workflow and advanced analyt...

BioTissue Introduces Shelf-Stable CAM360 AmnioGraft for Dry Eye, Other Disorders

BioTissue announced June 3 that it was launching the CAM360 AmnioGraft, a new hydrated, shelf-stable cryopreserved amniotic membrane product for mild to moderate dry eye and other ocular surface di...

Nordic Pharma Launches Lacrifill Canalicular Gel for Dry Eye in US

Nordic Pharma announced May 29 that it had launched Lacrifill canalicular gel for dry eye in the US. Lacrifill is a cross-linked hyaluronic acid derivative intended to temporarily block tear draina...

Santen Recalls All Unexpired Lots of Diquas LX Over Issues with Preservative

Santen has issued a voluntary recall and suspended shipment for all unexpired lots of its dry eye treatment Diquas LX in Japan due to issues with a preservative, Pharma Japan reported May 23. Sante...

Q1-2024 Ophthalmic Revenue Roundup for AbbVie, Iridex, and Biogen

AbbVie, of North Chicago, Illinois, reported April 26 that its Q1-2024 eye care net revenue totaled $538 million, an 11.7 percent decline (-10.4 percent cc) from $608 million in Q1-2023. Restasis r...

Emerging Companies Pursuing Ophthalmic Indications, May 2024

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

May 2024 Ophthalmic News Briefs

Taiwan-based Formosa Pharmaceuticals announced May 9 that it had entered into an exclusive licensing agreement with Tabuk Pharmaceuticals to market clobetasol propionate 0.05% eye drops for post-su...

Q1-2024 Ophthalmic Revenue Roundup for Alcon, Carl Zeiss Meditec, and Harrow

Alcon reported May 13 that its Q1-2024 net sales were $2.4 billion, a 5 percent increase (+7 percent cc) over $2.3 billion in Q1-2023. Surgical net sales totaled $1.34 billion, consisting of $433 m...

Q1-2024 Ophthalmic Revenue Roundup for Apellis, STAAR, RxSight, Tarsus, Sight Sciences, and Three Others

Apellis Pharmaceuticals, of Waltham, Massachusetts, reported May 7 that its Q1-2024 US net product revenue for Syfovre was $137.5 million, compared with $18.4 million in Q1-2023. Syfovre gained US ...

Lumibird Launches C.Diag Diagnostic Platform for Dry Eye

France’s Lumibird Medical announced May 3 that it had launched C.Diag, a dry eye diagnostic imaging platform incorporating artificial intelligence, after gaining the European Union’s CE marking for...

Q1-2024 Ophthalmic Revenue Roundup for Bausch + Lomb, Glaukos, and Lumibird

Bausch + Lomb reported May 1 that its Q1-2024 revenue was $1.1 billion, an 18 percent increase (+20 percent cc) over $931 million in Q1-2023. Vision Care segment revenue in Q1-2024 was $635 million...

Dry Eye Screening Before Surgery Seems Logical, but Hurdles Remain

The need to continue lobbying for dry eye evaluation prior to patients undergoing anterior segment surgery is somewhat baffling. Such testing seems like an obvious approach for the many patients wh...

Eyecelerator Celebrates Fourth Anniversary While Showcasing Innovation in Ophthalmology

A nor’easter storm that disrupted many travel itineraries failed to deter the nearly 600 industry personnel and clinicians who attended Eyecelerator ahead of the 2024 ASCRS meeting. This year’s con...

April 2024 Ophthalmic News Briefs

Alexion, the rare disease unit of AstraZeneca, announced March 25 that the US FDA had approved its long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for adults with neuromyelitis opt...

Aldeyra Outlines New Reproxalap Trial, Aims to Resubmit NDA in Dry Eye

Aldeyra Therapeutics on March 28 outlined its new clinical development plan for reproxalap eye drops, with the goal of resubmitting its new drug application (NDA) to the US FDA. The company said it...

2023 Ophthalmic Revenue Roundup for Iridex and NovaBay

Iridex, of Mountain View, California, reported March 26 that its 2023 revenue was $51.9 million, a 9 percent decrease from $57 million in 2022. Cyclo G6 product revenue was $13.4 million, a 9 perce...

Okyo’s Dry Eye Candidate Hits Multiple Phase II Endpoints, Including Ocular Pain Relief

London’s Okyo Pharma released additional findings on March 22 from its Phase II trial of topical dry eye candidate OK-101. The company had previously reported statistically significant improvements...

2023 Ophthalmic Revenue Roundup for Harrow, Alimera Sciences, and EyePoint

Nashville, Tennessee-based Harrow reported March 19 that its 2023 revenue was $130.2 million, a 47 percent increase over $88.6 million in 2022. The company generated record quarterly revenue in Q4-...

Amring Adopts Name Nordic Pharma Amid Ownership Change

Amring Pharmaceuticals announced March 4 that it had changed its name to Nordic Pharma Inc., following the change in ownership of the company from Sever Life Sciences to Nordic Group in June 2023. ...

Eye Ointments Sold at Walmart, CVS Recalled Due to Infection Risk

India’s Brassica Pharma announced Feb. 12 that it was voluntarily recalling eye ointments sold by retailers such as Walmart and CVS due to a danger of infection. The company said an inspection by t...

Clinical Trial Updates for Ophthalmic Candidates, March 2024

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

Ocular Tx Leads Latest Ophthalmic Fundraising with $325 Million Private Placement

Ocular Therapeutix led recent ophthalmic fundraising efforts with a $325 million private placement to advance its candidate for wet age-related macular degeneration. Financing announced in the past...

March 2024 Ophthalmic News Briefs

Germany’s VSY Biotechnology launched its Enova Maestro trifocal toric preloaded intraocular lens (IOL) at the European Society of Cataract and Refractive Surgeons (ESCRS) Winter Meeting, held Feb. ...

Weekly Surgeon Poll, March 2024

Emerging Companies Pursuing Ophthalmic Indications, March 2024

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

2023 Ophthalmic Revenue Roundup for Sight Sciences and Ocular Therapeutix

Sight Sciences reported March 7 that it generated 2023 total revenue of $81.1 million, an increase of 14 percent over $71.3 million in 2022. Surgical glaucoma revenue in 2023 was $74.3 million, a 1...

NovaBay, Eyenovia Team Up to Co-promote Ophthalmic Products

Eyenovia and NovaBay Pharmaceuticals announced March 13 the signing of a co-promotion agreement to commercialize their prescription ophthalmic products. Under the agreement, NovaBay will market Eye...

Richard Lindstrom, MD, Becomes Chairman of Surface Ophthalmics

Surface Ophthalmics, of Pleasanton, California, has named co-founder and director Richard Lindstrom, MD, as chairman. The company, which is developing dry eye drugs, was formed in 2018. Lindstrom w...

Vital Tears Appoints Joseph Tauber, MD, as Chief Medical Officer

Vital Tears announced March 6 that it had appointed Joseph Tauber, MD, as its chief medical officer. In 2023, Vital Tears added mobile phlebotomy services to its system of providing autologous seru...

Tarsus Prices $100 Million Public Offering

Tarsus Pharmaceuticals, of Irvine, California, announced March 1 that it had priced an underwritten public offering of shares and warrants, with expected gross proceeds of $100 million. Goldman Sac...

2023 Ophthalmic Revenue Roundup for Alcon, Bausch + Lomb, STAAR, Glaukos, Apellis, and Tarsus

Alcon reported Feb. 27 that its full year 2023 net sales totaled $9.4 billion, an 8 percent increase (+10 percent cc) over $8.7 billion in 2022. Q4-2023 sales were $2.3 billion, an 8 percent increa...

Eye Ointments Sold at Walmart, CVS Recalled Due to Infection Risk

India’s Brassica Pharma announced Feb. 12 that it was voluntarily recalling eye ointments sold by retailers such as Walmart and CVS due to a danger of infection. The company said an inspection by t...

China’s LianBio to Wind Down Operations, Sell Off Pipeline Assets

Chinese biotech company LianBio announced Feb. 13 that it would wind down operations—including selling its pipeline assets, delisting its American Depositary Shares from the Nasdaq, and cutting its...

Clinical Trial Updates for Ophthalmic Candidates , February 2024

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

February 2024 Ophthalmic News Briefs

Amneal Pharmaceuticals announced Jan. 10 that it had received US FDA approval for and launched generic fluorometholone eye drops. The product is indicated for the treatment of corticosteroid-respon...

Harrow Licenses Rights to Five Drugs to Apotex for Canada

Harrow reported Feb. 15 that it had licensed to Apotex exclusive marketing and distribution rights to Verkasia and over-the-counter Cationorm Plus in the Canadian market. In addition, Apotex will p...

China’s LianBio to Wind Down Operations, Sell Off Pipeline Assets

Chinese biotech company LianBio announced Feb. 13 that it would wind down operations—including selling its pipeline assets, delisting its American Depositary Shares from the Nasdaq, and cutting its...

Sylentis’ Topical Candidate for Sjögren’s Dry Eye Misses Endpoints in Phase III

Spain’s Sylentis, a PharmaMar Group company, announced Feb. 9 that tivanisiran, a topical treatment candidate for dry eye disease associated with Sjögren’s syndrome, did not meet primary efficacy e...

2023 Ophthalmic Revenue Roundup for Regeneron, AbbVie, Amgen, and Astellas

Regeneron, of Tarrytown, New York, reported Feb. 2 that its 2023 US revenue for Eylea 2 mg (aflibercept 2 mg) and Eylea HD (aflibercept 8 mg) totaled $5.9 billion, a 6 percent decline from $6.3 bil...

2023 in Review: Bausch + Lomb Makes Big Moves, Adding Product Lines and Building Partnerships

Bausch + Lomb made a flurry of big moves in 2023, with product approvals, acquisitions, leadership changes, and strategic partnerships and collaborations following the company’s IPO in mid-2022. In...

Select US FDA Approvals and Clearances in December 2023

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

Clinical Trial Updates for Ophthalmic Candidates, January 2024

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

2023 in Review: US FDA Cracks Down on OTC Eye Drops Amid Fatal Infections

Makers of over-the-counter eye drops came under increased surveillance from the US FDA in 2023, in part because contaminated products manufactured in India caused at least 81 people to become infec...

2023 in Review: Two Drugs with New Mode of Action Mark Upheaval in Dry Eye

The US FDA approved a new class of drugs to treat the signs and symptoms of dry eye disease in 2023. Two new treatments in the class, Miebo and Vevye, are both based on perfluorocarbon (PFC) molecu...

Alcon Reports Positive Topline Results in Phase III for AR-15512 in Dry Eye

Alcon reported Jan. 9 that it saw positive topline results from two pivotal Phase III clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512 in dry eye. AR-15512, a TR...

Ji Xing Leads Latest Ophthalmic Fundraising with $162 Million in Series D Round

China’s Ji Xing Pharmaceuticals led recent ophthalmic fundraising efforts with $162 million in Series D funding to advance its pipeline, which includes five ophthalmic candidates. Financing announc...

January 2024 Ophthalmic News Briefs

Maker of Sophi Phaco Machines UK-based Rayner announced Jan. 17 that it had acquired Switzerland’s This AG, the maker of Sophi phacoemulsification machines. No financial details were disclosed. Sop...

Harrow Launches Dry Eye Drug Vevye in US

Harrow, of Nashville, Tennessee, reported Jan. 11 that dry eye drugVevye is now available in the US. Vevye (cyclosporine ophthalmic solution) 0.1% is a non‑preserved, twice-daily-dosed prescription...

Alcon Reports Positive Topline Results in Phase III for AR-15512 in Dry Eye

Alcon reported Jan. 9 that it saw positive topline results from two pivotal Phase III clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512 in dry eye. AR-15512, a TR...

Nordic Pharma Subsidiary Acquires Visant Medical, Will Launch Lacrifill for Dry Eye in US

Nordic Pharma subsidiary Amring Pharmaceuticals announced Dec. 18 that it had completed its acquisition of Visant Medical. Visant received US FDA 510(k) clearance in 2022 for its Lacrifill cross-li...

Tarsus Reports Positive Topline Results from Phase IIa Trial of TP-03 for MGD with Demodex

Tarsus Pharmaceuticals, of Irvine, California, reported Dec. 11 that TP-03 (lotilaner ophthalmic solution, 0.25%) saw positive topline results in the Phase IIa Ersa trial of patients with meibomian...

US FDA Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for New Trial to Show Symptom Relief

Aldeyra Therapeutics reported Nov. 27 that the US FDA had, as expected, issued a complete response letter rejecting the company’s new drug application (NDA) for topical reproxalap as a treatment fo...

FDA Report Details Problems Found at Indian Manufacturer of Recalled OTC Eye Drops in US

The US FDA has released its preliminary report of an inspection conducted Oct. 12-20 at Kilitch Healthcare India, manufacturer of 27 over-the-counter eye drop products that were recalled Nov. 13 du...

Clinical Trial Updates for Ophthalmic Candidates, December 2023

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

FDA Approves 11 Ophthalmic Drug Products in 2023, Rejects Three More

2023 was a busy year for the US FDA in ophthalmology. Among the 11 drug products approved were the first two therapies in the US to treat geographic atrophy; two new drops for dry eye; and a second...

US FDA Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for New Trial to Show Symptom Relief

Aldeyra Therapeutics reported Nov. 27 that the US FDA had, as expected, issued a complete response letter rejecting the company’s new drug application (NDA) for topical reproxalap as a treatment fo...

US FDA Report Details Problems Found at Indian Manufacturer of Recalled OTC Eye Drops

The US FDA has released its preliminary report of an inspection conducted Oct. 12-20 at Kilitch Healthcare India, manufacturer of 27 over-the-counter eye drop products that were recalled Nov. 13 du...

Amazon Removes Seven Eye Drop Products After FDA Warning

Online retailer Amazon has removed seven eye drop products from its site after the US FDA warned the company that the products were unapproved drugs, making claims to relieve conjunctivitis or floa...

New Products, Shift to Generic Cyclosporine Expected to Shake Up Slumping Dry Eye Market

Dry eye revenue continues to fall in the US this year, despite new products, as generic cyclosporine ophthalmic solutions and emulsions increase market share at the expense of brand name Restasis. ...

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...

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 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...

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

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 ...

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

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...

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...

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

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...

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 ...

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...

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 ...

Acquisitions and OUS Investments Drive Ophthalmic Deals in Third Quarter of 2023

Ophthalmic deals in Q3-2023 reached nearly $2.8 billion and involved 22 transactions. This compares with $6.9 billion from 24 transactions in Q2-2023 and $1.0 billion from 20 transactions in Q3-202...

Tilak Leads Latest Ophthalmic Fundraising with $10.6 Million Round

France’s Tilak Healthcare led recent ophthalmic fundraising efforts with a $10.6 million funding round for its medical video games for chronic vision disorders. Financing announced in the past four...

Buzzworthy Topics at the 2023 ESCRS Congress

Minimally Invasive Glaucoma Surgery (MIGS): The ESCRS highlighted the growing importance of MIGS this year by holding the meeting’s first MIGS master class. Several speakers in other sessions extol...

Clinical Trial Updates for Ophthalmic Candidates, October 2023

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

October 2023 Ophthalmic News Briefs

Théa Pharma, the US subsidiary of France’s Laboratoires Théa, announced the launch Sept. 26 of once-daily Iyuzeh (latanoprost ophthalmic solution) 0.005% in the US market. Iyuzeh is the first prese...

Emerging Companies Pursuing Ophthalmic Indications, October 2023

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

Sight Sciences to Cut 25 Employees as it Awaits MACs’ Coverage Decision

Sight Sciences, of Menlo Park, California, has informed its employees that it will cut its workforce of 250 by 25 employees as it awaits a final decision by five of the seven Medicare Administrativ...

US FDA Finds ‘Substantive’ Issues with Aldeyra’s NDA for Reproxalap in Dry Eye

Aldeyra Therapeutics reported in a securities filing on Oct. 16 that the US FDA had found “substantive” issues with the company’s new drug application (NDA) for topical dry eye candidate reproxalap...

Merakris Unveils Nationwide At-Your-Door Autologous Serum Tears Program

Merakris Therapeutics unveiled its Opticyte Tears program on Oct. 12—offering to deliver personalized autologous serum tears in less than two hours, without patients ever having to leave home. Mera...

CS Pharmaceuticals acquires AxeroVision and Cream-Based Dry Eye Candidate

London-based CS Pharmaceuticals reported July 28 that it had acquired AxeroVision, of Carlsbad, California, and its AXR-270 candidate for dry eye disease. The company did not report financial detai...

Mati Completes Facility to Manufacture Evolute Punctal Plug Portfolio

Mati Therapeutics, of Austin, Texas, reported Sept. 12 that it had completed a 10 thousand square foot facility in Bryan, Texas, to manufacture the company’s Evolute sustained drug delivery platfor...

Bausch + Lomb Launches Dry Eye Drop Miebo in the US

Bausch + Lomb announced Sept. 12 the US launch of Miebo (perfluorohexyloctane ophthalmic solution) for dry eye disease. The US FDA approved Miebo in May for dosing four times daily. Bausch + Lomb a...

FDA Warns Eight Companies Over Marketing Unapproved or Unsafe Eye Drops in the US

The US FDA reported Sept. 12 that it had issued warning letters to eight companies for manufacturing or marketing unapproved eye drug products, expanding the list of companies that the FDA has targ...

Brim Leads Latest Ophthalmic Fundraising with $45.8 Million Rights Issue

Brim Biotechnologies, of Taiwan, led recent ophthalmic fundraising efforts with a $45.8 million rights issue to advance its lead dry eye candidate. Funding announced in the past four weeks totaled ...

Clinical Trial Updates for Ophthalmic Candidates, September 2023

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

September 2023 Ophthalmic News Briefs

Carl Zeiss Meditec announced Aug. 23 that more than 8 million eyes had been treated with the company’s SMILE procedure through the first half of 2023. SMILE, short for small-incision lenticule extr...

Bausch + Lomb Launches Dry Eye Drop Miebo in the US

Bausch + Lomb announced Sept. 12 the US launch of Miebo (perfluorohexyloctane ophthalmic solution) for dry eye disease. The US FDA approved Miebo in May for dosing four times daily. Bausch + Lomb a...

FDA Warns Eight Companies Over Marketing Unapproved Eye Drops

The US FDA reported Sept. 12 that it had issued warning letters to eight companies for manufacturing or marketing unapproved eye drug products, expanding the list of companies that the FDA has targ...

Link Biologics Partners with Théa Open Innovation to Develop Dry Eye Candidate

Link Biologics, of London, and France’s Théa Open Innovation announced Sept. 12 that they had agreed to co-develop Link’s topical anti-inflammatory candidate TSG6 for dry eye disease and other opht...

Viatris Reports Q2-2023 Tyrvaya Net Sales of $10.2 Million

Viatris, of Pittsburgh, reported Aug. 7 that its Tyrvaya nasal spray for dry eye accounted for net sales of $10.2 million in Q2-2023. The prescription treatment posted net sales of $6.3 million in ...

FDA Warns of Contamination in Certain MSM Eye Drops; Brand is Recalled

The US FDA issued a warning on Aug. 22 telling consumers not to purchase and to immediately stop using Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops—Eye Repair due to bacterial cont...

Q2-2023 Ophthalmic Revenue Roundup for AbbVie, Carl Zeiss Meditec, Alimera

AbbVie, of North Chicago, Illinois, reported July 27 that Q2-2023 net revenue for its eye care products totaled $617 million, a 13.9 percent decline from $717 million in Q2-2022. Restasis revenue w...

EMA Accepts Marketing Application for Dry Eye Candidate CyclASol from Novaliq

Novaliq, of Heidelberg, Germany, announced Aug. 24 that the European Medicines Agency (EMA) had accepted its marketing authorization application for dry eye candidate CyclASol (cyclosporine ophthal...

US FDA Approves Xdemvy Eye Drops from Tarsus for Demodex Blepharitis

Tarsus Pharmaceuticals announced July 25 that the US FDA had approved Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis. Xdemvy, formerly known as TP-03, is the ...

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

Kriya Therapeutics led recent ophthalmic fundraising efforts with $150 million in a Series C financing to advance its gene therapy candidates. Funding announced in the past four weeks totaled $456....

US FDA Target Action Dates for Ophthalmic Drug Candidates, August to December 2023

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