Xdemvy (lotilaner ophthalmic) / Tarsus Pharma, LianBio - LARVOL DELTA

Pediatric blepharokeratoconjunctivitis: review of epidemiology, pathophysiology, and current treatments. (PubMed, Curr Opin Ophthalmol) - "Pediatric blepharokeratoconjunctivitis is a chronic inflammatory condition affecting the eyelids, conjunctiva, and cornea. It is underdiagnosed and associated with significant vision-threatening complications. While there is no established consensus on the most effective therapeutic strategy, management currently includes lid hygiene, topical/systemic antibiotics, corticosteroids, immunosuppressants, lubricants, and dietary supplements. Challenges arise from its chronicity, recurrence, and lack of standardized treatment protocols. This underscores the importance of early diagnosis, education, and continued research on treatment methods to prevent severe outcomes."

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

Abstracts Highlighting the Global Prevalence of Demodex Blepharitis and the Clinical Impact of XDEMVY at the American Society of Cataract and Refractive Surgery (ASCRS) 2025 Annual Meeting (GlobeNewswire) - "Tarsus Pharmaceuticals, Inc...will present four distinct data sets highlighting the global prevalence and real-world patient burden of Demodex blepharitis, as well as the impact of XDEMVY (lotilaner ophthalmic solution) 0.25% in addressing objective measures of disease at the American Society of Cataract and Refractive Surgery (ASCRS) 2025 Annual Meeting, taking place April 25-28, 2025, in Los Angeles, Calif."

Clinical data • Ophthalmology

Meibomian Gland Function and Patient-Reported Outcomes with Lotilaner Ophthalmic Solution, 0.25% on Demodex Blepharitis Patients with Meibomian Gland Disease (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 • Patient reported outcomes • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Comparison of the in Vitro Efficacy of Tea Tree Oil vs. Lotilaner on Ocular Demodex (ARVO 2025) - "After the FDA approved a new medication containing lotilaner, Xdemvy has become more prominent and is advertised to be safer and more effective than other methods...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 • Ocular Inflammation • Ophthalmology

Lotilaner for Demodex Blepharitis: The Journey from Veterinary Use to Human Medicine. (PubMed, J Ocul Pharmacol Ther) - "In 2023, Xdemvy® (0.25% lotilaner ophthalmic solution) was approved by the U.S. FDA for treating Demodex blepharitis in humans...Other products evaluated for treating Demodex blepharitis include ivermectin eye ointment, ivermectin-metronidazole gel, permethrin cream, terpinen-4-ol wipes, and hypochlorous acid spray. Along with these, azithromycin eye drop, azithromycin/loteprednol eye drop, and other treatments are being evaluated for treating blepharitis. Other drugs from the isoxazoline drug class including afoxolaner, sarolaner, and fluralaner, could also be potentially explored for human use."

Journal • Review • Dry Eye Disease • Infectious Disease • Inflammatory Arthritis • Lyme Disease • Ocular Inflammation • Ophthalmology

Tarsus Reports Strong Fourth Quarter and Full-Year 2024 Financial Results and Recent Business Achievements (GlobeNewswire) - "XDEMVY continued to be one of the fastest growing therapeutics in eye care. Generated $66.4 million and $180.1 million in XDEMVY net product sales for the fourth quarter and full-year 2024, respectively. Dispensed more than 58,500 and 163,000 bottles to patients in the fourth quarter and full-year 2024, respectively."

Sales • Dry Eye Disease • Ocular Inflammation

Tarsus Reports Strong Fourth Quarter and Full-Year 2024 Financial Results and Recent Business Achievements (GlobeNewswire) - "Additional Potential Growth Drivers in 2025 and Beyond: On-track for potential European regulatory approval of a preservative-free formulation of XDEMVY in 2027. Initiated market development work, including Key Opinion Leader engagement, disease education and scientific presentations at major conferences. In Japan, the Company expects to share results from a DB prevalence study in the first half of 2025, and meet with Japanese regulatory authorities to help determine a regulatory path forward. The Chinese regulatory agency, National Medical Products Administration, accepted the New Drug Application (NDA) submitted by Tarsus’ partner, Grand Pharmaceutical Group Ltd., for TP-03 for DB."

China filing • Clinical data • EMA approval • Dry Eye Disease

Safety and Efficacy of Lotilaner Ophthalmic Solution (0.25%) in Treating Demodex Blepharitis: Pooled Analysis of Two Pivotal Trials. (PubMed, Ophthalmol Ther) - P2/3, P3 | "Twice-daily treatment with lotilaner ophthalmic solution (0.25%) for 6 weeks demonstrated statistical significance for all outcome measures compared to the vehicle control, with low rates of adverse events and a high rate of drop comfort."

Clinical • Journal • Retrospective data • Dermatology • Dry Eye Disease • Ocular Inflammation • Ophthalmology

DEMODEX BLEPHARITIS- AN UNDERRECOGNIZED DIAGNOSIS (ACAAI 2024) - "Emerging therapies like lotilaner ophthalmic solution are being investigated for their efficacy in eradicating Demodex mites...We should consider routinely conducting an extended range of skin prick tests with different families of mites, as well as measuring specific IgE levels in cases where symptoms persist and traditional mites have tested negative. Targeted treatments like lotilaner can offer significant symptom relief and improve quality of life for patients suffering from Demodex blepharitis."

Allergic Rhinitis • Dry Eye Disease • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Pruritus

Safety & Efficacy Of Lotilaner Ophthalmic Solution, 0.25% In Treating Demodex Blepharitis: Pooled Analysis Of Two Pivotal Trials (ESCRS 2024) - "Results of the combined analysis of two pivotal trials demonstrated the safety and efficacy of lotilaner ophthalmic solution, 0.25% for the treatment of Demodex blepharitis."

Retrospective data • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Multidisciplinary perspectives in Demodex blepharitis: A new view of treatment from clinical, payer, and patient perspectives. (PubMed, J Manag Care Spec Pharm) - "Lotilaner ophthalmic solution 0.25%, the first approved therapy for treatment of Demodex blepharitis, has not only been shown to eradicate Demodex mites in one-half to two-thirds of patients following short-term treatment but also demonstrated continued benefits through 1 year of follow-up...As eye care professionals recognize Demodex infestation as a key mediator of ocular surface disease, increasing diagnostic awareness and addressing this underlying cause of Demodex blepharitis may reduce the need for specialist follow-up care, decrease the need for chronic therapy, and improve patient outcomes. Through routine screening for Demodex infestation and Demodex blepharitis, eye care professionals can now address an underlying factor in ocular surface disease to improve use of health care resources in the community."

Journal • Review • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Ocular and Systemic Pharmacokinetics of Lotilaner Ophthalmic Solution, 0.25%, Following a Single Dose or Repeated Doses in Dutch-Belted Rabbits. (PubMed, J Ocul Pharmacol Ther) - " Lotilaner ophthalmic solution, 0.25%, demonstrated rapid ocular tissue absorption into the eyelid margin tissue with a long half-life of almost a week. No adverse effects were observed following topical ocular administration in Dutch-belted rabbits."

Journal • PK/PD data • Preclinical • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis. (PubMed, Healthcare (Basel)) - "As high as 92% of the patients receiving lotilaner eyedrops in the phase 3 trials found it to be neutral to very comfortable. Given the positive safety and efficacy outcomes, the drug is likely to become the standard of care in the treatment of Demodex blepharitis."

Journal • Review • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Lotilaner (Xdemvy) for Demodex blepharitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study (clinicaltrials.gov) - P3 | N=163 | Completed | Sponsor: LianBio LLC | Active, not recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Effect of Management Options on Demodex Blepharitis Patients (ARVO 2024) - "Until recent FDA approval of lotilaner ophthalmic solution 0.25%, various management options and medications, were used off-label for symptom management in DB... The results highlight the unclear benefit of prescription immunomodulatory dry eye topical medications used off-label and other management options in alleviating ocular symptoms in patients with DB. Off-label use of therapies, including prescription anti-inflammatory topical medications, may worsen the symptomatology of DB patients."

Clinical • Dry Eye Disease • Ocular Inflammation • Ophthalmology

A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Tarsus Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed

Trial completion

Rhea: Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: Tarsus Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Ariel: Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers (clinicaltrials.gov) - P4 | N=166 | Recruiting | Sponsor: Tarsus Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2024 ➔ Dec 2024 | Trial primary completion date: Aug 2024 ➔ Dec 2024

Enrollment open • Trial completion date • Trial primary completion date • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Rhea: Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Tarsus Pharmaceuticals, Inc. | Trial completion date: Jan 2024 ➔ Jun 2024 | Trial primary completion date: Jan 2024 ➔ Jun 2024

Trial completion date • Trial primary completion date • Dry Eye Disease • Ocular Inflammation • Ophthalmology

XdemvyTM (Lotilaner Ophthalmic Solution) 0.25% Topical Solution for the Treatment of Demodex Blepharitis. (PubMed, Skinmed) - "The adverse events were mild, with the most common being pain at instillation site. The recommended regimen for lotilaner 0.25% solution is one drop in each eye twice daily for 6 weeks."

Journal • Dermatology • Dry Eye Disease • Ocular Inflammation • Ophthalmology • Pain

Efficacy and Safety of Lotilaner Ophthalmic Solution (0.25%) for the Treatment of Demodex Blepharitis: A GRADE Assessed Systematic Review and Meta-Analysis of Observational & Experimental Studies. (PubMed, Am J Ophthalmol) - "Our results indicated that Lotilaner is an effective, well-tolerated, and promising drug in treating patients with Demodex blepharitis. Lotilaner administration and cost-effectiveness should now be contemplated for the study population as these constituents have a vital impact on its treatment success."

Journal • Retrospective data • Review • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Efficacy and Safety of Lotilaner Ophthalmic Solution 0.25% for the Treatment of Demodex Blepharitis: A Meta-Analysis of Randomized Controlled Trials. (PubMed, Cont Lens Anterior Eye) - "This systematic review and meta-analysis provides robust evidence supporting the efficacy of 0.25% lotilaner ophthalmic solution in treating Demodex blepharitis. Approval of this targeted therapy represents a significant milestone in ophthalmology and offers a promising treatment option for patients with Demodex blepharitis. Eye care professionals should consider the potential benefits of lotilaner in managing and alleviating the symptoms associated with Demodex infestations on the eyelids. Further research and long-term follow-up studies are warranted to assess the safety and effectiveness of lotilaner in treating Demodex blepharitis."

Journal • Retrospective data • Review • Dermatology • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology

A Systematic Review and Meta-Analysis of the Safety and Efficacy of 0.25% Lotilaner Ophthalmic Solution in the Treatment of Demodex Blepharitis. (PubMed, Cureus) - "It demonstrated safety with no reported side effects compared to the vehicle. Direct comparative studies with alternative treatments are recommended for a comprehensive assessment of efficacy and safety."

Journal • Retrospective data • Review • CNS Disorders • Dermatology • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology

Long-Term Outcomes of 6-Week Treatment of Lotilaner Ophthalmic Solution, 0.25%, for Demodex Blepharitis: A Noninterventional Extension Study. (PubMed, Cornea) - "After 6-week treatment with lotilaner ophthalmic solution, 0.25%, for Demodex blepharitis, no long-term concerns were observed during 1 year of follow-up. A high proportion of patients with 0 to 2 collarettes (grade 0) or ≤10 collarettes (collarette grade of 0 or 1) was observed throughout 1 year of follow-up, indicating that the efficacy of lotilaner ophthalmic solution, 0.25%, against Demodex blepharitis may last well after completion of therapy."

Journal • Dermatology • Dry Eye Disease • Ocular Inflammation • Ophthalmology