libvatrep eye drop (SAF312 eye drops) / Bausch Health - LARVOL DELTA

Ocular Pharmacology and Toxicology of TRPV1 Antagonist SAF312 (Libvatrep). (PubMed, Transl Vis Sci Technol) - "Ocular tissue and plasma pharmacokinetics (PK) were assessed following a single topical ocular dose of SAF312 (0.5%, 1.0%, 1.5%, 2.5%) in rabbits. SAF312 is a potent, selective, and noncompetitive antagonist of hTRPV1 with an acceptable preclinical safety profile for use in future clinical trials. SAF312, which was safe and well tolerated without causing delay in wound healing after PRK in rabbits, may be a potential therapeutic agent for ocular surface pain."

Journal • Pain • TRPV1

Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP) (clinicaltrials.gov) - P2 | N=153 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Surgery • Trial completion • Cataract • Pain

Topical Ocular TRPV1 Antagonist SAF312 (Libvatrep) for Postoperative Pain After Photorefractive Keratectomy. (PubMed, Transl Vis Sci Technol) - "SAF312 was well tolerated and effective in reducing ocular pain post-PRK. Topical SAF312 presents a new therapeutic option for patients undergoing PRK."

Journal • Pain • TRPV1

Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP) (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Surgery • Cataract • Pain

"Monish Jain et al. @NovartisScience evaluated the safety, tolerability, pharmacokinetics, and effect on corneal sensitivity of topical ocular SAF312 in healthy participants. https://t.co/GeeYT3gnjx" (@ARVOtvst)

Clinical • PK/PD data

Topical Ocular TRPV1 Antagonist SAF312 (Libvatrep) Demonstrates Safety, Low Systemic Exposure, and No Anesthetic Effect in Healthy Participants. (PubMed, Transl Vis Sci Technol) - "This first-in-human (FIH) study evaluated the safety, tolerability, pharmacokinetics, and effect on corneal sensitivity of topical ocular SAF312 in healthy participants. SAF312 was well tolerated, with no ocular or systemic safety concerns; had no anesthetic effect, and demonstrated rapid topical absorption with low systemic exposure. This work bridges the gap between basic research and clinical care by providing FIH data of SAF312, supporting the further investigation as a potential treatment for ocular surface pain."

Journal • Anesthesia • Pain • TRPV1

PO080 - Chronic Ocular Surface Pain: Patient Journey and Results From Topical Ocular SAF312 (Libvatrep) Clinical Trials (AAO 2022) - "Early data show SAF312 is well tolerated and can effectively manage ocular pain in the immediate post-PRK period."

Clinical • Ophthalmology

Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP) (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Dec 2022 ➔ Apr 2023 | Trial primary completion date: Dec 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Cataract • Pain

[VIRTUAL] Topical ocular TRPV1 antagonist SAF312 was well tolerated and effectively reduced pain after photorefractive keratectomy (PRK) (ARVO 2021) - P2 | "Topical SAF312 was well tolerated and effective in reducing ocular pain in the immediate post-PRK period. SAF312 is currently under evaluation for postop corneal induced chronic pain (NCT04630158)."

Astigmatism • Ophthalmology

[VIRTUAL] Topical ocular TRPV1 antagonist SAF312 demonstrated safety, low systemic exposure, and no anesthetic effect in healthy volunteers (ARVO 2021) - "Topical ocular SAF312 was well tolerated with no ocular or systemic safety concerns up to a supratherapeutic (8x daily) dose of the maximum concentration (2.5%); it had no anesthetic effect on the cornea and demonstrated a rapid topical absorption with low systemic exposure in healthy volunteers."

Clinical • Ocular Inflammation • Ophthalmology

Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP) (clinicaltrials.gov) - P2; N=150; Recruiting; Sponsor: Novartis Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Pain

Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP) (clinicaltrials.gov) - P2; N=150; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

Clinical • New P2 trial • Pain