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

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

Osmotica Pharmaceuticals plc to Provide Second Quarter 2020 Business and Financial Update and Presentation on Upneeq on August 11, 2020 (BioSpace) - "Company to discuss launch plans for Upneeq and will be joined by Dr. Derek Cunningham, OD, FAAO."

Launch