Dioptin (lipoic acid choline ester chloride) / Novartis - LARVOL DELTA

One-Month Topical Treatment with LB-01, a Novel Small Molecule Treatment for Presbyopia, Significantly Restores Lens Flexibility Lost to Aging in Mice and is Superior to LACE (ARVO 2024) - "Our data shows that LB-01 is an effective lens stiffness reducing agent. Notably, Lipoic Acid Choline Ester (which was being developed under the name UNR844) proved insufficiently efficacious in the Phase 2B READER trial for presbyopia conducted by Novartis and development was discontinued. Superior efficacy to this molecule in direct comparison, as well as strong overall results over just 1 month of treatment, suggest that LB-01 has significant potential in the treatment of presbyopia."

Preclinical • Ophthalmology

A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia. (clinicaltrials.gov) - P2 | N=235 | Terminated | Sponsor: Novartis Pharmaceuticals | Completed ➔ Terminated; The study was discontinued by the Sponsor because it did not achieve the primary objective of demonstrating a statistically significant dose response at Month 3.

Trial termination • Ophthalmology

A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia. (clinicaltrials.gov) - P2 | N=235 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology

"Really disappointing that UNR844 is being dropped." (@idiot3qu3)

"What a shame - .@Novartis is dropping UNR844 https://t.co/IyNiSHkyhT" (@idiot3qu3)

Pharmacological treatment of presbyopia: A systematic review. (PubMed, Eur J Transl Myol) - "Currently there is no pharmacological agent available to treat presbyopia. Although there are limited number of peer-reviewed articles available, the outcome for future agents under investigation are promising."

Journal • Review • Ophthalmology

A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia. (clinicaltrials.gov) - P2 | N=235 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Apr 2023 ➔ Sep 2022

Trial completion date • Ophthalmology

"UNR844. Where is it?" (@Raytional)

A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia. (clinicaltrials.gov) - P2 | N=235 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology

A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia. (clinicaltrials.gov) - P2 | N=225 | Recruiting | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Recruiting

Enrollment open • Ophthalmology

A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia. (clinicaltrials.gov) - P2 | N=238 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology

Unr-844 (ASCRS-ASOA 2022) - No abstract available

Presbyopia - A Review of Current Treatment Options and Emerging Therapies. (PubMed, Clin Ophthalmol) - "Non-invasive therapies with novel mechanisms of action are currently being investigated; these include miotic agents and UNR844, a lipoic acid choline ester...The diagnosis pathway and patient journey in presbyopia are outlined, and various treatment options are analyzed. The data reviewed herein reveals significant gaps in the provision of vision correction for this common condition, with a paucity of effective, non-invasive treatment options broadly accessible to presbyopic individuals."

Journal • Review • Dry Eye Disease • Ophthalmology • Retinal Disorders

A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia. (clinicaltrials.gov) - P2; N=225; Recruiting; Sponsor: Novartis Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Ophthalmology

A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia. (clinicaltrials.gov) - P2; N=225; Not yet recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Sep 2022 ➔ Mar 2023; Trial primary completion date: Jan 2022 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • Ophthalmology

A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia. (clinicaltrials.gov) - P2; N=225; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

Clinical • New P2 trial • Ophthalmology

Topical lipoic acid choline ester eye drop for improvement of near visual acuity in subjects with presbyopia: a safety and preliminary efficacy trial. (PubMed, Eye (Lond)) - "These results support further development of UNR844 ophthalmic solution for the treatment of presbyopia."

Clinical • Journal • Ophthalmology

"@NovartisUS @NovartisUSMed any projection when UNR844 will be available to the public??" (@minnie_jax)

[VIRTUAL] Clinical Evaluation of a Mobile Application for Home near Visual Acuity Monitoring (AAOPT 2020) - P2 | "We evaluated a novel mobile application (app) for near VA self-monitoring in presbyopic subjects both at home and at the clinic. Methods The app was evaluated as part of a clinical trial of the investigational drug UNR844 (NCT03809611)...In addition, it is possible that the clinically significant difference between ETDRS and Landolt C acuities observed in several visual diseases may also apply in this setting in a way that would also impact the LOA. Encouraging data from this study is informing the development and validation of this mobile app for near VA monitoring at home."

Clinical • Ocular Infections • Ophthalmology

[VIRTUAL] UNR844 Ophthalmic Solution for the Topical Treatment of Presbyopia: Results of a Phase II Randomised Controlled Trial (AAOPT 2020) - P2 | "There were no clinically meaningful differences in ocular or systemic side effects between UNR844 and placebo. Conclusion On the basis of the median improvement in DCNVA from baseline with UNR844 versus placebo and Phase I/II results, further clinical development is planned in a Phase IIb dose-finding study. Future studies will also include mitigation strategies to minimize DCNVA variability."

Clinical • P2 data • Ophthalmology

[VIRTUAL] Clinical evaluation of a mobile application for near visual acuity monitoring at home (EURETINA 2020) - P2 | "Setting: Evaluation of VA assessment performance by a mobile app used at home and at the clinic in presbyopic subjects participating in a three-month, multi-center, double-masked, placebo-controlled, randomized, parallel-group clinical trial of the investigational drug UNR844 (NCT03809611)... The mobile app measured near VA in less than one minute at high and low contrast conditions both at the clinic and at home, with an inter-visit variability of the app comparable to the eVA measured at the clinic. The present oLOAs, which are slightly above 0.3 logMAR, are strongly influenced by the higher than expected variability observed for the reference eVA measurements at the clinic. A possible explanation may be the effect of optical defocus on the test/retest variability of visual acuity measurements which has been reported previously in the literature."

Clinical • Diabetic Retinopathy • Ocular Infections • Ophthalmology • Retinal Disorders

A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia. (clinicaltrials.gov) - P2; N=124; Completed; Sponsor: Novartis Pharmaceuticals; Recruiting ➔ Completed; Trial primary completion date: Jul 2019 ➔ Dec 2019

Clinical • Trial completion • Trial primary completion date

Pharmacologic solutions to presbyopia (Cataract & Refractive Surgery Today) - "Pupillary miotics will be the first pharmacologic treatments for presbyopia to market. These agents have demonstrated safety, efficacy, and ease of use in early studies. It remains to be seen which patient populations will be best suited to this form of treatment, and further research is required to demonstrate these agents’ long-term tolerability. Results thus far, however, suggest that pupillary miotics will enable many people to function without wearing glasses. Lens-softening drops also hold promise for the treatment of presbyopia, and the results of a phase 2 trial are currently being evaluated."

Online posting

A Clinical Study Evaluating the Safety and Efficacy of UNR844 Chloride 1.5% Topical Ophthalmic Solution in Subjects with Presbyopia (ASCRS-ASOA 2020) - "The adverse events were recorded. Conclusion These Results further guide the development of UNR844 ophthalmic solution for the treatment of presbyopia."

Clinical

Novel eye drops may improve farsightedness and replace reading glasses, finds study (Speciality Medical Dialogues) - "'Presbyopia literally means ‘old eye’ and results in a gradual decrease in lens accommodation, leading to a significant lack of functional near vision,' said Sheri Rowen, MD of NVISION Eye Centers in Newport Beach, during her presentation. 'It affects the majority of people over the age of 40, with a target population of 30 to 40 million in the United States, and we have no approved pharmacologic treatment.'"

Media quote