Upneeq (oxymetazoline hydrochloride) / RVL Pharma, Santen - LARVOL DELTA

A Multiple-Dose Pharmacokinetics (PK) Study of STN1013800 in Healthy Adults (ChiCTR) - P1 | N=8 | Completed | Sponsor: Beijing Chaoyang Hospital, Capital Medical University; Beijing Chaoyang Hospital, Capital Medical University

New P1 trial

A Pharmacokinetics (PK) Study in Healthy Adults (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Santen Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion

A Pharmacokinetics (PK) Study in Healthy Adults (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Santen Pharmaceutical Co., Ltd.

New P1 trial

LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) in the Treatment of Acquired Blepharoptosis. (clinicaltrials.gov) - P3 | N=234 | Recruiting | Sponsor: Santen SAS | Not yet recruiting ➔ Recruiting

Enrollment open

LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) in the Treatment of Acquired Blepharoptosis. (clinicaltrials.gov) - P3 | N=234 | Not yet recruiting | Sponsor: Santen SAS | Initiation date: Nov 2024 ➔ Mar 2025

Trial initiation date

Oxymetazoline Drops for Acquired Blepharoptosis from Synkinesis (clinicaltrials.gov) - P3 | N=48 | Enrolling by invitation | Sponsor: Milton S. Hershey Medical Center | Trial completion date: Jan 2025 ➔ Jul 2026 | Trial primary completion date: Oct 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • CNS Disorders • Ophthalmology

A Study in Chinese Patients With Acquired Blepharoptosis (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Santen Pharmaceutical Co., Ltd.

New P3 trial • Ophthalmology

LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) in the Treatment of Acquired Blepharoptosis. (clinicaltrials.gov) - P3 | N=234 | Not yet recruiting | Sponsor: Santen SAS

New P3 trial

Oxymetazoline Drops for Acquired Blepharoptosis From Synkinesis (clinicaltrials.gov) - P3 | N=48 | Enrolling by invitation | Sponsor: Milton S. Hershey Medical Center | Recruiting ➔ Enrolling by invitation

Enrollment status • CNS Disorders • Ophthalmology

Oxymetazoline Drops for Acquired Blepharoptosis From Synkinesis (clinicaltrials.gov) - P3 | N=48 | Recruiting | Sponsor: Milton S. Hershey Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Ophthalmology

Oxymetazoline Drops for Acquired Blepharoptosis From Synkinesis (clinicaltrials.gov) - P3 | N=48 | Not yet recruiting | Sponsor: Milton S. Hershey Medical Center | Initiation date: Aug 2023 ➔ Nov 2023

Trial initiation date • CNS Disorders • Ophthalmology

Oxymetazoline Drops for Acquired Blepharoptosis From Synkinesis (clinicaltrials.gov) - P3 | N=48 | Not yet recruiting | Sponsor: Milton S. Hershey Medical Center

New P3 trial • CNS Disorders • Ophthalmology

The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance (clinicaltrials.gov) - P4 | N=114 | Completed | Sponsor: University of Miami | Active, not recruiting ➔ Completed

Trial completion

Management of Severe Botulinum-Induced Eyelid Ptosis With Pre-tarsal Botulinum Toxin and Oxymetazoline Hydrochloride 0.1. (PubMed, Aesthet Surg J) - "This is the first documented case series of patients effectively treated with Oxymetazoline HCl 0.1% and pre-tarsal BoNT-A injections in the setting of botox-induced ptosis. This treatment combination is a safe and effective option in these cases."

Journal

"Looking forward to our 2022 #AntiAging #Eyecare #Innovations Day @VisionOptique @JNJVision #AcuvueMAX @abbvie #vuity #upneeq #EverTear @EyesaretheStory #ocularaesthetics #digitaleyehealth #digitaleyedoc https://t.co/uPkCdQWjqQ" (@DrBridgitte)

The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance (clinicaltrials.gov) - P4 | N=114 | Active, not recruiting | Sponsor: University of Miami | Recruiting ➔ Active, not recruiting

Enrollment closed

"$RVLP UPNEEQ® Wins Best Professional-Treatment Product by Shape Magazine in the 2022 "Shape Healthy Skin Awards" https://t.co/VtlM7HjsVc" (@stock_titan)

Clinical

"$OSMT RVL Pharmaceuticals to Host UPNEEQ® Overview and Business Update Webcast on January 19, 2022 https://t.co/IFjCrmlmH1" (@stock_titan)

The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance (clinicaltrials.gov) - P4; N=110; Recruiting; Sponsor: University of Miami; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

[VIRTUAL] Clinical responsiveness to RVL-1201, a novel oxymetazoline 0.1% ophthalmic solution for the treatment of acquired blepharoptosis: results from two phase 3 clinical studies (ARVO 2021) - "These data support previously reported efficacy findings from phase 3 clinical studies. A large proportion of subjects demonstrated a positive response to once-daily RVL-1201 administration (superior visual field improvement). These results substantiate RVL-1201 as a potentially promising non-surgical treatment option for patients with acquired blepharoptosis."

Clinical • P3 data • Ophthalmology

[VIRTUAL] PO298: Efficacy and Safety of RVL-1201 (Oxymetazoline 0.1%) for Acquired Blepharoptosis: Patient Subgroup Analysis from Two Phase 3 Studies (AAO 2020) - "Adverse event rates with RVL-1201 were comparable across subgroups, ranging from 24.3% to 38.5%. Conclusion RVL-1201 used once daily for 42 days had a consistent efficacy and safety profile across subgroups based on age or race."

Clinical • P3 data • Ophthalmology

Dr. John Hovanesian TV6 Interview- Upneeq (YouTube) - "Harvard Eye offers the first FDA-approved prescription eye drop indicated for the treatment of acquired blepharoptosis, also known as 'droopy eyelid' called Upneeq."

Interview • Video

[VIRTUAL] Industry Innovation Lunch sponsored by RVL Pharmaceuticals, Inc. - Managing Ptosis in Your Practice (AAOPT 2020) - "Dr. Walter Whitley will review the mechanism of action and clinical data for RVL-1201, a new prescription eyedrop to treat acquired blepharoptosis in adults"

Ophthalmology

[VIRTUAL] Safety Profile of a Novel Oxymetazoline Hydrochloride Ophthalmic Solution in Development for the Treatment of Acquired Blepharoptosis: Integrated Results from Four Clinical Studies (AAOPT 2020) - "RVL-1201 was reported to cause “no discomfort” by 100%, 95.5%, and 92.0% of subjects using RVL-1201 once-daily for 2 weeks, 6 weeks, and 12 weeks, respectively. Conclusion The data from four double-masked, controlled clinical trials support the safety and tolerability of once-daily administration of RVL-1201 dosed up to 12 weeks. Taken together with previously reported efficacy data, these results support RVL-1201 as a potentially promising non-surgical treatment option for patients with acquired blepharoptosis."

Clinical • Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology

Managing Ptosis with RVL-1201/Upneeq - Drs. Melissa Barnett, Susan Resnick & Jason Bacharach (YouTube) - "...Melissa Barnett...will help us learn more about ptosis, including causes, diagnosis, treatment landscape, impact on patients, and opportunity for your practice."

Video