NovaTears (perfluorohexyloctane) / Novaliq, Jiangsu Hengrui Pharma, Bausch Health, AFT Pharma, Ursapharm - LARVOL DELTA

Early Patient-Reported Satisfaction in Patients Initiated on Perfluorohexyloctane for Dry Eye Disease (ISPOR 2025) - "PFHO patients reported high satisfaction with their medication, with a majority refilling their prescription. Almost all PFHO patients had prior OTC eye drop usage for over 12 months, potentially identifying a subset of the patient population likely to benefit from the novel treatment."

Clinical • Dry Eye Disease • Ophthalmology

In vitro biophysical and biological profiling of commercial lipid-based dry eye products. (PubMed, Eur J Pharm Sci) - "Seven commercial lipid-based eye drops (Cationorm®, Desodrop®, Evotears®, Oxyal® Triple Action, PuroTM Suoja, Systane® Complete, Thealipid®) were selected for the in vitro biophysical and biological profiling studies. Clear differences in cell viability and recovery were observed, with three of the products being able to promote the recovery of damaged cells. However, the significance of our findings with regards to DED treatment outcomes will require additional studies."

Journal • Preclinical • Dry Eye Disease • Ophthalmology

Early symptom relief and satisfaction with perfluorohexyloctane ophthalmic solution in dry eye disease: a prospective, open-label, multicenter study (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Dry Eye Disease • Ophthalmology

Perfluorohexyloctane ophthalmic solution in patients with dry eye disease and cataract: post hoc analysis of pooled data from pivotal trials (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Retrospective data • Cataract • Dry Eye Disease • Ophthalmology

Early adoption and utilization of perfluorohexyloctane ophthalmic solution for dry eye disease (ARVO 2025) - "CsA 0.05% (21.8%) and lifitegrast (17.1%) were most commonly used...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Dry Eye Disease • Ocular Inflammation • Ophthalmology

The effect of Perfluorohexyloctane on a mouse model of blue light-induced meibomian gland dysfunction (ARVO 2025) - "Perfluorohexyloctane (SHR8058), a clear, low-surface-tension liquid with a refractive index similar to water, has shown promise in stabilizing the tear film and delaying MGD progression...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Preclinical • Dry Eye Disease • Ophthalmology • IFNG • IL1B • IL4 • IL6 • NFKB1 • NOX4 • TNFA

Effect of the dry eye drop perfluorohexyloctane and comparator semifluorinated alkanes on the evaporation rate of saline in vitro (ARVO 2025) - "This in vitro study evaluated the impact of chain length on SFA evaporation rate (Revap) and inhibition of Revap of saline by assessing several SFAs including two dry eye drops, one consisting of 100% SFA (perfluorohexyloctane; F6H8; MIEBO®) the other which includes the SFA perfluorobutylpentane (F4H5) as a vehicle (cyclosporine ophthalmic solution 0.1%; CsA 0.1%; VEVYE®)...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Preclinical • Dry Eye Disease • Ophthalmology

Early Effects of Perfluorohexyloctane Ophthalmic Solution on Patient-Reported Outcomes in Dry Eye Disease: A Prospective, Open-Label, Multicenter Study. (PubMed, Ophthalmol Ther) - P4 | "Early in the course of treatment with PFHO, patients with DED experienced significant reductions in dry eye symptom frequency and severity. Treatment satisfaction with PFHO was high."

Clinical • Journal • Dry Eye Disease • Ophthalmology • Pain

In Vitro and In Vivo Visualization of Perfluorohexyloctane, an Eye Drop for Dry Eye Disease, Using Infrared Emissivity. (PubMed, Cornea) - "PFHO quickly spread to form a layer over the surface of saline or meibum in vitro and was detected on the ocular surface in vivo for ≥5 hours after topical administration. This supports findings that PFHO forms a long-lasting barrier to evaporation at the air-liquid interface of the tear film and thus reduces signs and symptoms of DED."

Journal • Preclinical • Dry Eye Disease • Ophthalmology

A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months. (clinicaltrials.gov) - P4 | N=216 | Active, not recruiting | Sponsor: Bausch & Lomb Incorporated | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2026 ➔ Nov 2025 | Trial primary completion date: Feb 2026 ➔ Nov 2025

Enrollment closed • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

Perfluorohexyloctane ophthalmic solution for dry eye disease: pooled analysis of two phase 3 clinical trials. (PubMed, Front Ophthalmol (Lausanne)) - P3 | "Compared with a hypotonic saline control, perfluorohexyloctane improved both the signs and symptoms of DED, including in patients with greater self-reported severity of eye dryness. This study represents an integrated analysis of 2 previous clinical trials: GOBI (ClinicalTrials.gov, NCT04139798) and MOJAVE (ClinicalTrials.gov, NCT04567329)."

Journal • P3 data • Retrospective data • Dry Eye Disease • Ophthalmology

Factors associated with the speed of response to perfluorohexyloctane eye drops (SHR8058) in dry eye disease associated with meibomian gland dysfunction: a post-hoc analysis of a randomized, phase 3 trial (EVER 2024) - No abstract available

Clinical • P3 data • Retrospective data • Dry Eye Disease • Ophthalmology

A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months. (clinicaltrials.gov) - P4 | N=200 | Recruiting | Sponsor: Bausch & Lomb Incorporated

New P4 trial • Dry Eye Disease • Ophthalmology

Effects of perfluorohexyloctane on the ocular pharmacokinetics of latanoprost and prednisolone acetate after topical administration to rabbits (ARVO 2024) - " Male Dutch Belted rabbits received a single topical ocular dose of either latanoprost ophthalmic solution 0.005% (Group 1), PFHO followed by latanoprost (Group 2), prednisolone acetate ophthalmic suspension 1% (Group 3), or PFHO followed by prednisolone acetate (Group 4)... In this preclinical rabbit study, prior instillation of PFHO had no effect on the ocular PK profile of latanoprost acid or prednisolone, suggesting there would be no impact of PFHO on the efficacy of these medications. Based on these findings, the presence of PFHO on the ocular surface appears unlikely to affect absorption of other topical ocular drops in patients with DED on multiple medications."

PK/PD data • Preclinical • Dry Eye Disease • Ophthalmology

Effects of perfluorohexyloctane on corneal healing in an ex vivo study of rabbit corneas (ARVO 2024) - "In these ex vivo eye irritation tests, PFHO was found to promote corneal healing of the epithelium of abraded rabbit corneas. These findings are consistent with the improvements in the signs and symptoms of DED observed in clinical studies of PFHO."

Preclinical • Corneal Abrasion • Dry Eye Disease • Ophthalmology

Preclinical Toxicity Profile of Perfluorohexyloctane Ophthalmic Solution (ARVO 2024) - "These preclinical findings, including ocular dosing for up to 6 months duration, support the safety of PFHO for the treatment of patients with signs and symptoms of dry eye disease. The safety and efficacy of PFHO in patients with dry eye disease was further assessed in one phase 2 clinical trial (SEECASE) and three phase 3 clinical trials (GOBI, MOJAVE, and KALAHARI)."

Preclinical • Dry Eye Disease • Ophthalmology

Efficacy of perfluorohexyloctane ophthalmic solution in patients with dry eye disease stratified by baseline severity (ARVO 2024) - "Results of the post-hoc analysis indicate that PFHO is efficacious in the treatment of signs and symptoms of DED in patients with mild or moderate disease."

Clinical • Dry Eye Disease • Ophthalmology

Early Adoption and Utilization of Perfluorohexyloctane for Treatment of Dry Eye Disease (ISPOR 2024) - " Adults (≥18 years) in the Veradigm Network Electronic Health Record (VNEHR) Database initiating DED treatment with either perfluorohexyloctane, cyclosporine ophthalmic solution 0.05% (CYC-S) (Restasis), lifitegrast (LFT) (Xiidra), and cyclosporine ophthalmic emulsion 0.09% (CYC-E) (Cequa) from September 2023 to December 2023 were selected... Early adopters of PHO were slightly younger and had a higher proportion of patients with a DED diagnosis compared to other agents. PHO tended to have more treatment-experienced patients in the 12 months prior to initiation, potentially highlighting a subgroup of the patient population who were waiting for a new treatment option for evaporative DED in addition to inflammation."

Cataract • Dry Eye Disease • Glaucoma • Inflammation • Ocular Inflammation • Ophthalmology

Effects of NOV03 on the Tear Film (clinicaltrials.gov) - P4 | N=27 | Completed | Sponsor: Bausch & Lomb Incorporated | Not yet recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

Long-Term Safety and Efficacy of Perfluorohexyloctane Ophthalmic Solution for the Treatment of Patients With Dry Eye Disease: The KALAHARI Study. (PubMed, Cornea) - "PFHO was safe and well tolerated and maintained efficacy for improving signs and symptoms of DED in this year-long study of patients with DED associated with Meibomian gland dysfunction."

Journal • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

Influence of perfluorohexyloctane (Evotears®) on higher order aberrations. (PubMed, Int Ophthalmol) - "F6H8 may be a suitable treatment option to improve the accuracy of refractive assessment, although it increases HOA. Further studies are needed to confirm the effect on HOA and the repeatability of measurement."

Journal • Dry Eye Disease • Ophthalmology

Oxygen-Carrying Capacity of Perfluorohexyloctane, a Novel Eye Drop for Dry Eye Disease. (PubMed, Curr Ther Res Clin Exp) - "The current study confirms that PFHO contains a significant amount of oxygen, more so than that calculated for tears in equilibrium with air. Once instilled on the eye, PFHO is not expected to be a barrier to the oxygen necessary for a healthy cornea and may in fact deliver nonreactive oxygen to the cornea to facilitate healing in patients with dry eye disease."

Journal • Dry Eye Disease • Ophthalmology

In Vitro Inhibition of Evaporation with Perfluorohexyloctane, an Eye Drop for Dry Eye Disease. (PubMed, Curr Ther Res Clin Exp) - "PFHO significantly inhibited the R of saline in this in vitro model. The data support the idea that PHFO may form an antievaporative layer on the tear film surface and may be a functional substitute for the native tear-film lipid layer in patients with dry eye disease."

Journal • Preclinical • Dry Eye Disease • Ophthalmology

Bausch + Lomb Announces New Scientific Data and Analyses Featuring Consumer, Vision Care and Pharmaceutical Products Will Be Presented During American Optometric Association's Optometry's Meeting (Businesswire) - "Bausch + Lomb Corporation...today announced that researchers will present the results of 11 scientific poster presentations involving the company’s consumer, vision care and pharmaceutical products during the American Optometric Association (AOA) Optometry’s Meeting e-posters Virtual Event, which is taking place from June 13-14, 2023. In addition, the company will host several sponsored education events at the Optometry’s Meeting in Washington, D.C. from June 21-24, 2023....The poster presentations will include data from the two pivotal Phase 3 trials, GOBI and MOJAVE, and 12-month KALAHARI safety extension study of MIEBO™ (perfluorohexyloctane ophthalmic solution)."

P3 data • Preclinical • Retrospective data • Dry Eye Disease • Ophthalmology

CORRECTING and REPLACING Senju Pharmaceutical and Novaliq Enter Into License Agreement For NOV03 (Perfluorohexyloctane Ophthalmic Solution) For the Treatment of Dry Eye Disease in Japan (Businesswire) - "Japan rights to develop, manufacture, and commercialize NOV03 (perfluorohexyloctane ophthalmic solution), the first and only prescription treatment for signs and symptoms of dry eye disease that directly targets tear evaporation....Under the terms of the license agreement, Novaliq is eligible to receive upfront and milestone payments contingent upon the achievement of regulatory and sales milestones as well as royalties on net sales of NOV03 in Japan."

Licensing / partnership • Dry Eye Disease • Ophthalmology