Pro-ocular (progesterone gel) / Glia, SIFI - LARVOL DELTA

Signal12 Achieves FDA Alignment, Accelerating Pro-ocular Towards Phase 3 Clinical Trials for Ocular Graft-versus-Host Disease (PRNewswire) - "Signal12, Inc...announced the alignment of its Phase 3 clinical trial strategy for Pro-ocular with the U.S. Food and Drug Administration (FDA). Pro-ocular is a novel drop-free therapy poised to revolutionize the treatment of ocular Graft-versus-Host Disease (oGvHD). This key regulatory milestone, achieved following a highly productive Type C meeting, sets the stage for Signal12's transformative Phase 3 clinical research in an area of high unmet medical need....'The FDA's positive feedback on our Phase 3 trial design underscores the urgent need for new and effective interventions for oGvHD.'"

FDA event • New P3 trial • Graft versus Host Disease

Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101 (clinicaltrials.gov) - P2 | N=49 | Completed | Sponsor: Glia, LLC | Unknown status ➔ Completed

Adverse events • Trial completion • Glaucoma • Ophthalmology

ProGIFT: Safety and Efficacy of Two Different Concentrations (0.5% and 1%) of Progesterone Topical Gel Compared to Placebo in Patients Diagnosed With Moderate to Severe Dry Eye Syndrome (clinicaltrials.gov) - P2 | N=96 | Completed | Sponsor: SIFI SpA | Recruiting ➔ Completed | Trial completion date: Mar 2022 ➔ Oct 2022 | Trial primary completion date: Feb 2022 ➔ Oct 2022

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

Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens Wearing Patients With Ocular Graft-versus-Host Disease (clinicaltrials.gov) - P2/3; N=38; Recruiting; Sponsor: Glia, LLC; Enrolling by invitation ➔ Recruiting

Clinical • Enrollment status • Graft versus Host Disease • Immunology

ProGIFT: Safety and Efficacy of Two Different Concentrations (0.5% and 1%) of Progesterone Topical Gel Compared to Placebo in Patients Diagnosed With Moderate to Severe Dry Eye Syndrome (clinicaltrials.gov) - P2; N=105; Recruiting; Sponsor: SIFI SpA; Trial completion date: Nov 2021 ➔ Mar 2022; Trial primary completion date: Oct 2021 ➔ Feb 2022

Clinical • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

Treatment of Dry Eye Disease Using Pro-ocular™ - A Proof of Concept, Safety, and Efficacy Study (clinicaltrials.gov) - P2; N=80; Enrolling by invitation; Sponsor: PharmaDax Inc.

Clinical • New P2 trial • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens Wearing Patients With Ocular Graft-versus-Host Disease (clinicaltrials.gov) - P2/3; N=38; Enrolling by invitation; Sponsor: Glia, LLC; Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Graft versus Host Disease • Immunology

ProGIFT: Safety and Efficacy of Two Different Concentrations (0.5% and 1%) of Progesterone Topical Gel Compared to Placebo in Patients Diagnosed With Moderate to Severe Dry Eye Syndrome (clinicaltrials.gov) - P2; N=105; Recruiting; Sponsor: SIFI SpA; Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Ocular Infections • Ophthalmology

Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT. (clinicaltrials.gov) - P2; N=33; Active, not recruiting; Sponsor: Glia, LLC; Enrolling by invitation ➔ Active, not recruiting; Trial completion date: Dec 2019 ➔ Nov 2021; Trial primary completion date: Oct 2019 ➔ Oct 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Graft versus Host Disease • Immunology • Transplantation

A Phase II/III Trial of Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens Wearing Patients With Ocular Graft-versus-Host Disease (clinicaltrials.gov) - P2/3; N=38; Not yet recruiting; Sponsor: Glia, LLC

Clinical • New P2/3 trial • Graft versus Host Disease • Immunology

ProGIFT: Safety and Efficacy of Two Different Concentrations (0.5% and 1%) of Progesterone Topical Gel Compared to Placebo in Patients Diagnosed With Moderate to Severe Dry Eye Syndrome (clinicaltrials.gov) - P2; N=105; Not yet recruiting; Sponsor: SIFI SpA

Clinical • New P2 trial • Dry Eye Disease • Ocular Infections • Ophthalmology

A clinical trial to evaluate the Safety and Efficacy of Pro-ocular™ topical gel in two different concentration, 0.5% and 1%, when administered in the forehead twice a day for 12 weeks in Patients diagnosed with Dry Eye Syndrome. Studio clinico per valutare la sicurezza e l'efficacia del gel topico Pro-ocular™ in due diverse concentrazioni, 0.5% e 1%, applicato sulla fronte due volte al giorno. (clinicaltrialsregister.eu) - P2; N=105; Ongoing; Sponsor: SOCIETÀ INDUSTRIA FARMACEUTICA ITALIANA (SIFI) SPA

Clinical • New P2 trial • Dry Eye Disease • Fatigue • Immunology • Inflammation • Ocular Infections • Ophthalmology • Pruritus