PL9643 / Palatin Technologies - LARVOL DELTA

Efficacy and safety of PL9643 in participants with dry eye disease: results from a phase 3, randomized, vehicle-controlled 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 • P3 data • Dry Eye Disease • Ocular Inflammation • Ophthalmology

MELODY-1: A Phase 3, Multi-Center Study Evaluating PL9643 in Patients with Dry Eye (clinicaltrials.gov) - P3 | N=575 | Completed | Sponsor: Palatin Technologies, Inc | Recruiting ➔ Completed | N=240 ➔ 575 | Trial completion date: Dec 2022 ➔ Nov 2023

Enrollment change • Trial completion • Trial completion date • Dry Eye Disease • Ophthalmology

Quintessence of currently approved and upcoming treatments for dry eye disease. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Currently, the US Food and Drug Administration (FDA)-approved medical treatments for treatment of DED include cyclosporine formulations (RESTASIS® [cyclosporine 0.05% ophthalmic emulsion], VEVYE® [cyclosporine 0.1% ophthalmic solution], and CEQUA™ [cyclosporine 0.09% ophthalmic solution]), XIIDRA® (lifitegrast), a leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor, EYSUVIS™ (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid, and MIEBO™ (perfluorohexyloctane ophthalmic solution), a semifluorinated alkane. TYRVAYA™ (varenicline solution nasal spray), a cholinergic agonist, is another formulation approved for the treatment of the signs and symptoms of DED...Cyclosporine formulations TJO-087 (cyclosporine A nanoemulsion 0.08%), SCAI-001 eye drops (cyclosporine 0.01%, 0.02%) are being evaluated against RESTASIS® and other approved treatments. The potential treatments being assessed include..."

Journal • Review • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • ICAM1

Efficacy and Safety of the Melanocortin Pan-Agonist PL9643 in a Phase 2 Study of Patients with Dry Eye Disease. (PubMed, J Ocul Pharmacol Ther) - P2 | " PL9643 showed no significant efficacy for the ITT population; however, efficacy results across several signs and symptoms in the subpopulation of moderate to severe DED patients, the low number of ocular AEs, and no tolerability issues suggest that PL9643 shows promise as a therapeutic for DED. Clinical Trial Registration number: NCT04268069."

Journal • P2 data • Dry Eye Disease • Ophthalmology

"$PTN Palatin Invites Investors to Listen to Replay of the PL9643 Dry Eye Disease Key Opinion Leader Webinar https://t.co/dv3Svd6F5L" (@stock_titan)

Dry Eye Disease • Ophthalmology

Effectiveness of PL9643 in treating the signs and symptoms of moderate to severe dry eye disease including a subpopulation of hyper-responders to CAE® challenge: results from 2 independent clinical trials (ARVO 2023) - "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 • Ocular Inflammation • Ophthalmology

Melanocortin agonist PL9643 significantly improves ocular signs and symptoms of moderate to severe dry eye disease (DED), including tear film break up time (TFBUT) (ARVO 2022) - "In subjects with moderate or severe DED, PL9643 led to significant improvement in TFBUT at week 12 and other subjective and objective benefits at 2 weeks which were maintained for 12 weeks vs placebo. PL9643 had a safety profile comparable to placebo. Results support the continued development of PL9643 as a novel therapeutic method for DED."

Dry Eye Disease • Ocular Inflammation • Ophthalmology

MELODY-1: A Phase 3, Multi-Center Study Evaluating PL9643 in Patients With Dry Eye (clinicaltrials.gov) - P3; N=240; Recruiting; Sponsor: Palatin Technologies, Inc

Clinical • New P3 trial • Dry Eye Disease • Ophthalmology

[VIRTUAL] Efficacy and Safety of the Melanocortin Agonist PL9643 in a Phase 2 Study of Subjects With Dry Eye Disease (ARVO 2021) - "In subjects with moderate or severe dry eye disease, ophthalmic PL9643 solution led to significant subjective and objective benefits by the first evaluation at 2 weeks and maintained for 12 weeks. PL9643 was well tolerated, with a safety profile comparable to placebo. Positive results across multiple signs and symptoms support the continued development of PL9643 as a novel therapeutic method for treating dry eye disease."

Clinical • P2 data • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye (clinicaltrials.gov) - P2; N=160; Completed; Sponsor: ORA, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Dry Eye Disease • Ocular Infections • Ophthalmology

Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye (clinicaltrials.gov) - P2; N=150; Active, not recruiting; Sponsor: ORA, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Jul 2020 ➔ Oct 2020; Trial primary completion date: Jul 2020 ➔ Oct 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Dry Eye Disease • Ocular Infections • Ophthalmology

Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye (clinicaltrials.gov) - P2; N=150; Recruiting; Sponsor: ORA, Inc.

Clinical • New P2 trial

Palatin Technologies, Inc. announces first patient enrolled in dry eye disease phase 2 clinical trial with PL9643 (PRNewswire) - "Palatin Technologies...today announced that it has enrolled the first patient in a Phase 2 clinical trial of topical PL9643, a melanocortin 1/5 receptor (MC1/5r) agonist, for the treatment of dry eye disease (DED)....We expect to report data from this study in the fourth quarter of this calendar year."

Enrollment open • P2 data