Yuvezzi (brimonidine/carbachol) / Tenpoint Therapeutics - LARVOL DELTA

Tenpoint Therapeutics Announces United Kingdom YUVEZZI Submission of Marketing Authorization Application to the Medicines and Healthcare Products Regulatory Agency (MHRA) for the Treatment of Blurry Close-Up Vision (Presbyopia) in Adults (Businesswire) - "The MAA was submitted via the MHRA’s International Recognition Procedure (IRP), which is a streamlined regulatory pathway, and will consider the U.S. Food and Drug Administration (FDA) approval as part of the Procedure...The MAA submission is supported by positive data from two Phase 3, randomized, double-masked, controlled studies, BRIO I and BRIO II."

MHRA filing • Ophthalmology

Yuvezzi - a carbachol/brimonidine solution for presbyopia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Ophthalmology

Yuvezzi™ (carbachol and brimonidine tartrate) dual-agent eyedrops: a new option for presbyopia. (PubMed, Ann Med Surg (Lond)) - "Current management options include spectacles, contact lenses, pharmacologic agents such as pilocarpine, and surgical interventions; however, each approach carries limitations related to convenience, adaptability, or visual compromise. Common adverse effects included ocular discomfort, irritation, visual disturbances, and headache. Yuvezzi™ offers a noninvasive, reversible alternative for presbyopia management; however, long-term safety and sustained efficacy require further evaluation."

Journal • Ophthalmology • Pain

Tenpoint Therapeutics…announced that the U.S. Food and Drug Administration (FDA) approved YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as BRIMOCHOL PF, the first and only dual-agent eye drop for the treatment of presbyopia in adults (Businesswire) - "YUVEZZI is expected to be broadly commercially available in the U.S. in Q2 2026. The FDA approval of YUVEZZI is based on positive data from two Phase 3 studies. The Phase 3 BRIO I study demonstrated a superior benefit of the combination therapy over the individual actives....In the second Phase 3 study, BRIO II, which was vehicle-controlled, YUVEZZI achieved all primary near vision improvement endpoints with statistically significant three-lines or greater improvement in binocular uncorrected near visual acuity (BUNVA) over 8 hours, without the loss of one line or more in binocular uncorrected distance visual acuity (BUDVA)."

FDA approval • Launch US • Ophthalmology

Tenpoint Therapeutics Ltd. Announces Submission of a New Drug Application for BRIMOCHOL PF for the Treatment of Presbyopia to the MFDS in South Korea (Businesswire) - "The NDA submission in South Korea was supported by positive data from the first pivotal Phase 3 BRIO-I study....In the second vehicle-controlled Phase 3 BRIO-II study, BRIMOCHOL PF achieved all primary near vision improvement endpoints....Tenpoint Therapeutics has received a Prescription Drug User Fee Act (PDUFA) date from the U.S. Food and Drug Administration (FDA) of January 28, 2026."

Korea filing • PDUFA • Ophthalmology

Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia (clinicaltrials.gov) - P3 | N=629 | Completed | Sponsor: Visus Therapeutics | Active, not recruiting ➔ Completed | N=450 ➔ 629

Enrollment change • Trial completion • Ophthalmology

Tenpoint Therapeutics Ltd. Announces FDA Acceptance of New Drug Application for BRIMOCHOL PF for the Treatment of Presbyopia (Businesswire) - "Tenpoint Therapeutics, Ltd...announces that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for BRIMOCHOL PF for the treatment of presbyopia. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of January 28, 2026, for BRIMOCHOL PF. The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application...'With our commercial leadership team now in place, we are fully engaged in launch preparations as we anticipate a product availability in 1H 2026.'"

FDA filing • Launch US • PDUFA • Ophthalmology

Efficacy and Safety of BRIMOCHOL PF and CARBACHOL PF in Chinese Presbyopia Patients (clinicaltrials.gov) - P2 | N=119 | Recruiting | Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

New P2 trial • Ophthalmology

Tenpoint Therapeutics Ltd. Submits New Drug Application to U.S. FDA for BRIMOCHOL PF for the Treatment of Presbyopia (Businesswire) - "Tenpoint Therapeutics, Ltd....announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for BRIMOCHOL PF for the treatment of presbyopia, an age-related near-vision loss condition impacting approximately two billion people globally and 128 million people in the United States....The NDA submission is supported by positive data from the first pivotal Phase 3 BRIO-II study, which demonstrated the benefit of the combination therapy over the individual components – a requirement for FDA approval of a fixed-dose combination."

FDA filing • Ophthalmology

Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia (clinicaltrials.gov) - P2 | N=18 | Completed | Sponsor: Visus Therapeutics | N=81 ➔ 18

Enrollment change • Monotherapy • Ophthalmology

Tenpoint Therapeutics Announces Positive Topline Data from Phase 3 Pivotal Study, BRIO-II, of BRIMOCHOL PF for the Treatment of Presbyopia (Businesswire) - P3 | N=450 | BRIO-II (NCT05135286) | Sponsor: Visus Therapeutics | "BRIMOCHOL PF, successfully met the pre-specified visual acuity primary endpoints for both the US and EU/UK with highly statistically significant near vision improvements over 8 hours, paving the way for US filing in 1H, 2025; BRIMOCHOL™ PF was well-tolerated with no serious treatment-related adverse events in the largest and longest safety study ever conducted in the presbyopia eye drop category; BRIMOCHOL™ PF demonstrated a statistically significant improvement in ocular hyperemia over the investigational carbachol arm of the study."

FDA filing • P3 data: top line • Ophthalmology

Advantages of eliminating the cataract surgery post-operative day 1 appointment in a rural practice. (PubMed, Can J Rural Med) - "En éliminant des centaines de visites postopératoires du premier jour dans une région rural, les patients, leurs amis et leurs proches n'ont pas à SE rendre au cabinet (ce qui peut représenter des centaines de kilomètres aller-retour). L'emploi du temps du cabinet est libéré pour accueillir davantage de patients et l'empreinte carbone des patients liée à leur déplacement au cabinet est réduite."

Journal • Retrospective data • Surgery • Cataract • Infectious Disease • Novel Coronavirus Disease • Ophthalmology

Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia (clinicaltrials.gov) - P3 | N=450 | Active, not recruiting | Sponsor: Visus Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology

Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Visus Therapeutics | Trial completion date: May 2023 ➔ Dec 2024 | Trial primary completion date: Mar 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Ophthalmology

Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia (clinicaltrials.gov) - P3 | N=182 | Completed | Sponsor: Visus Therapeutics | Recruiting ➔ Completed | Trial completion date: Jan 2023 ➔ Apr 2023

Trial completion • Trial completion date • Ophthalmology