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

NGL-Long Term: A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Bausch & Lomb Incorporated | N=150 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Dry Eye Disease • Ophthalmology

A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear (clinicaltrials.gov) - P4 | N=100 | Active, not recruiting | Sponsor: Bausch & Lomb Incorporated | Recruiting ➔ Active, not recruiting

Enrollment closed • Dry Eye Disease • Ophthalmology

Factors Associated With Perfluorohexyloctane Treatment Response in Dry Eye Disease Associated With Meibomian Gland Dysfunction. (PubMed, Cornea) - P3 | "Baseline tCFS score and ametropia are critical factors associated with SHR8058 treatment response. Patients with a baseline tCFS score ≥6 and those with ametropia are more likely to achieve greater overall improvements of corneal surface condition and dry eye symptoms."

Journal • Dry Eye Disease • Ophthalmology

NGL-Long Term: A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Bausch & Lomb Incorporated

New P3 trial • Dry Eye Disease • Ophthalmology

A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Bausch & Lomb Incorporated | Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Ophthalmology

A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease (clinicaltrials.gov) - P2 | N=423 | Not yet recruiting | Sponsor: Bausch & Lomb Incorporated

New P2 trial • Dry Eye Disease • Ophthalmology

A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: Bausch & Lomb Incorporated

New P4 trial • Dry Eye Disease • Ophthalmology

Early Adoption and Utilization of Perfluorohexyloctane for Dry Eye Disease in the United States. (PubMed, Clin Ophthalmol) - "To characterize early adopters of perfluorohexyloctane (PFHO) and 90-day refill rates after the first prescription, overall and compared to a cohort initiating cyclosporine ophthalmic emulsion 0.05% (CsA)...High DED medication use among PFHO patients in the 12-month period prior to treatment initiation suggests that prior medication may not have resolved their DED symptoms. The higher 90-day refill rate for PFHO versus CsA indicates a higher degree of patient satisfaction with this new, first-in-class treatment for DED."

Journal • Dry Eye Disease • Ophthalmology

Corneal Staining Responder Analysis: A Clinically Meaningful Dry Eye Outcome. (PubMed, Ophthalmology) - "This analysis demonstrates that ≥ 3 severity grade improvement in corneal staining score is consistently associated with significant corresponding symptom improvement and may represent a clinically meaningful DED outcome measure for clinical studies and patient care."

Journal • Dry Eye Disease • Ophthalmology

Breakthrough in Ophthalmology! Hengrui’s Heng Qin (Perfluorohexyloctane Eye Drops) Approved as First Treatment for Dry Eye Disease Associated with MGD (Businesswire) - "Jiangsu Hengrui Pharmaceuticals..and Novaliq GmbH...announce today that the China National Medical Products Administration (NMPA) has approved Heng Qin (Perfluorohexyloctane Eye Drops) for the treatment of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Heng Qin is the first and only drug approved to treat DED associated with MGD and will be available to patients in China in the coming months...The NMPA approval of Heng Qin was based on a multi-center, randomized, controlled, double-blind, pivotal phase 3 clinical study in Chinese patients."

China approval • Dry Eye Disease

Ocular Pharmacokinetics and Biodistribution of Perfluorohexyloctane after Topical Administration to Rabbits. (PubMed, J Ocul Pharmacol Ther) - " Exposure of PFHO was highest in tears, consistent with its anti-evaporative mode of action, followed by the Meibomian glands. PFHO exposure was very low in posterior ocular tissues and negligible in systemic circulation, consistent with the clinical safety profile."

Journal • PK/PD data • Preclinical • Dry Eye Disease • Gastrointestinal Disorder • Ophthalmology

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