Vuity (pilocarpine) / AbbVie - LARVOL DELTA

Evaluation of NV701 (Pilocarpine 1.25%) Compared With Vuity (Pilocarpine 1.25%) on Pupil Size in Subjects With Presbyopia (clinicaltrials.gov) - P1 | N=55 | Completed | Sponsor: Novus Vision LLC | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology

Short-term Efficacy and Safety of Pilocarpine Ophthalmic Solution for Presbyopia: A Systematic Review and Meta-Analysis. (PubMed, Am J Ophthalmol) - "Pilocarpine demonstrated short-term efficacy in improving near vision in presbyopic patients, with an increased incidence of specific, mostly mild and transient adverse events and a consistent miotic effect. Further large-scale, long-term RCTs are warranted to confirm benefits, optimize dosing, and fully characterize its safety profile."

Clinical • Journal • Retrospective data • Review • Ophthalmology • Pain

Evaluation of NV701 (Pilocarpine 1.25%) Compared with Vuity (Pilocarpine 1.25%) on Pupil Size in Subjects with Presbyopia (clinicaltrials.gov) - P1 | N=52 | Active, not recruiting | Sponsor: Novus Vision LLC | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology

A Systematic Review and Meta-Analysis on the Efficacy and Safety of Topical Pilocarpine 1.25% in Presbyopia Treatment. (PubMed, J Curr Ophthalmol) - "Relevant articles were extracted from the online database using keywords - "pilocarpine and presbyopia", "AGN-190584 and presbyopia", and "Vuity and presbyopia". The available evidence documents significant improvement in near and intermediate vision in presbyopia participants with pilocarpine 1.25% drop. However, more RCTs, involving a wider age group, larger refractive error, longer follow-up, and clinical testing in a real-world scenario are required to conclusively prove its role in presbyopia management."

Journal • Retrospective data • Review • Ophthalmology • Pain • Retinal Disorders

Pharmacological Treatment of Presbyopia Using Pilocarpine 1.25% Eye Drops. (PubMed, J Ophthalmic Vis Res) - "To assess the efficiency and safety of pilocarpine eye drop 1.25% analogue (IR- Pilo) in comparison with its original brand-name drug (Vuity). IR-Pilo and Vuity eye drops had comparable results; both were effective and led to stable distance vision and improved near vision. Both ophthalmic drugs were safe and none of them were associated with significant adverse effects."

Journal • Ophthalmology

Evaluation of NV701 (Pilocarpine 1.25%) Compared with Vuity (Pilocarpine 1.25%) on Pupil Size in Subjects with Presbyopia (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: Novus Vision LLC

New P1 trial • Ophthalmology

Horseshoe Retinal Tear Minutes After Use of a New Pilocarpine Formulation in a Presbyopic, Emmetropic Man. (PubMed, J Vitreoretin Dis) - " This case highlights the need for comprehensive eye examinations and patient education about the warning signs of retinal tears or detachments before prescribing pilocarpine for presbyopia. Vigilance regarding the potential rare adverse effects of this new pilocarpine ophthalmic solution is warranted."

Journal • Hematological Disorders • Ophthalmology • Pain • Retinal Disorders

New Trents In Eye Care In Bahrain Most Recent Advances In Our Daily Eye Care Practice (ESCRS 2024) - "Purpose: This Abstract Explores The Integration Of New Trends In Ophthalmic Practice, Encompassing The Use Of Vuity Eye Drops, Tyrvaya Nasal Spray, Durysta, Cxl Unbound, Light Adjustable Lenses, Capsulaser, And Tepezza... Doing bilateral eye surgey whether refractive, ICL, or cataract surgery under topical anaesthesia as a day case have tremendous benefits to the patients and increased turnover of patients in eye care establishments in Bahrain."

Cataract • Ophthalmology • Strabismus

Understanding Perspectives on Presbyopia and Use of Pilocarpine HCl 1.25% Twice Daily from Participants of the Phase 3 VIRGO Study. (PubMed, Ophthalmol Ther) - "Findings validate the VIRGO results and improve our understanding of the patient experience, demonstrating improved vision and satisfaction with Pilo (vs. vehicle) when performing daily activities."

Journal • P3 data • Ophthalmology

Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: Gordon Schanzlin New Vision | N=30 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Ophthalmology

Impact of presbyopia treatment pilocarpine hydrochloride 1.25% on night-driving performance. (PubMed, Clin Exp Optom) - P3 | "The overall performance of night driving was inferior with pilo, compared with placebo. The study findings are consistent with the current class labelling and provide evidence to inform regulators and assist clinicians considering prescribing pilo to adults who seek treatment of presbyopia symptoms and drive at night.ClinicalTrials.gov identifier: NCT04837482."

Journal • CNS Disorders • Cognitive Disorders • Dry Eye Disease • Ophthalmology • Pain

Google Search Trends to assess public interest in and concern about Vuity for treating presbyopia. (PubMed, PLoS One) - "Google Trends is a useful tool for monitoring increases in public interest in Vuity for presbyopia. Public concerns regarding side effects warrant further real-world investigations of the causal relationship between Vuity and retinal detachment."

Journal • Ophthalmology • Retinal Disorders

Pilocarpine HCl 1.25% for Treatment of Presbyopia After Laser Vision Correction: A Pooled Analysis of Two Phase 3 Randomized Trials (GEMINI 1 and 2). (PubMed, J Cataract Refract Surg) - "Pilo treatment effectively and similarly improved DCNVA in presbyopes with or without a history of laser vision correction."

Journal • P3 data • Retrospective data • Ophthalmology

Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia (clinicaltrials.gov) - P1/2 | N=80 | Terminated | Sponsor: AbbVie | N=144 ➔ 80 | Trial completion date: Jun 2023 ➔ Dec 2022 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2023 ➔ Dec 2022; Company Decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Ophthalmology

Pilocarpine 1.25% Ophthalmic Solution (Vuity) for the Treatment of Presbyopia. (PubMed, Am Fam Physician) - No abstract available

Journal • Ophthalmology

SAFETY AND EFFICACY OF TWICE-DAILY PILOCARPINE HCL IN PRESBYOPIA: THE VIRGO PHASE 3, RANDOMIZED, DOUBLE-MASKED, CONTROLLED STUDY. (PubMed, Am J Ophthalmol) - "Near-vision improvements were statistically greater with Pilo BID than vehicle, without compromising distance acuity. Pilo BID's safety profile was consistent with that of Pilo once daily, and systemic accumulation was minimal, supporting BID administration."

Journal • P3 data • Ophthalmology • Pain

"@allerganeye @abbvie Are there any plans to launch Vuity in India anytime soon?" (@UgraPraani)

Increased Public Interest in Pilocarpine Drops for Presbyopia following Regulatory Approval and Direct-to-Consumer Ad Campaigns: A Google Trends Analysis (ARVO 2023) - "Changes in monthly relative search volumes were calculated for keywords “presbyopia”, “vuity”, “pilocarpine”, and “pilocarpine presbyopia”, following October 2021 FDA approval and March 2022 commercial advertisement...This may indicate that DTC advertising is playing a role in public interest in these eye drops. Furthermore, GT represents a powerful resource for providers to monitor these trends as they are emerging and anticipate the needs of our patients."

Ophthalmology

"FDA APPROVED: Twice-daily dosing option of Vuity for presbyopia. https://t.co/zgFkBJ5SrT @US_FDA @abbvie #OcularNews #Ophthalmology #OcularSurgery" (@Healio_OSN)

FDA event • Surgery • Ophthalmology

Persistence of Effect of Twice-Daily Pilocarpine HCl 1.25 % on Near Vision: Results of the Phase 3 VIRGO Study in Presbyopia (ASCRS-ASOA 2023) - "Purpose This exploratory analysis evaluated the progressive efficacy improvement of twice-daily (BID) pilocarpine HCl ophthalmic solution 1.25% (Vuity®, Pilo hereafter) on mesopic (10-11 lux at target) and photopic (≥251 lux) distance-corrected near visual acuity (DCNVA) in the 14-day, phase 3, randomized, double-masked, VIRGO study.MethodsParticipants (40‒55 yrs) with objective/subjective evidence of presbyopia impacting daily activities and mesopic, high-contrast, binocular DCNVA ranging from 20/40‒20/100 were randomized 1:1 to Pilo (N=114) or vehicle (N=116) BID, with doses 6 hours apart.On Days 1, 7, and 14, mesopic and photopic DCNVA (letters) were assessed at 40 cm before the first daily dose (baseline) and at Hours (H) 1, 3, 6 (pre-2nd dose), 7, and 9.Using a mixed effect model for repeated measures with day, age group, baseline DCNVA severity, iris color, and emmetrope status as fixed effects, least squares mean differences (standard error) in change in..."

P3 data • Ophthalmology

Phase 3, Randomized, Controlled VIRGO Study of Twice-Daily Pilocarpine HCl 1.25% in Presbyopia: Primary and Key Secondary Efficacy Endpoints (ASCRS-ASOA 2023) - "Purpose To report the primary and key secondary efficacy endpoints of the randomized, double-masked, controlled, phase 3 VIRGO study of pilocarpine hydrochloride 1.25% ophthalmic solution (Vuity®, Pilo hereafter) compared with vehicle (placebo) when administered bilaterally, twice daily (BID, 6 hours apart) for 14 days in participants with presbyopia.MethodsParticipants (40‒55 yrs) with objective/subjective evidence of presbyopia impacting daily activities and mesopic, high-contrast (HC), binocular distance-corrected near visual acuity (DCNVA) 20/40‒20/100 were randomized to Pilo BID or vehicle, packaged identically for masking.Primary efficacy endpoint: participants (%) gaining ≥3 lines in mesopic, HC, binocular DCNVA on Day 14 (last visit) Hour 9 (3 hrs postsecond dose) with ≤5-letter loss in mesopic corrected distance visual acuity with the same refractive correction.Key secondary efficacy endpoint: same as primary but in photopic conditions.Participants with..."

Clinical • P3 data • Ophthalmology

Mesopic Vision Improvement Aligns with Pupil Size Reduction in the VIRGO Study of Twice-Daily Pilocarpine HCl 1.25% in Presbyopia (ASCRS-ASOA 2023) - "Purpose Decreasing pupil size decreases defocus blur and the impact of peripheral aberration to improve vision.This exploratory analysis evaluated the changes in near visual acuity and pupil size from baseline with twice-daily pilocarpine HCl ophthalmic solution 1.25% (Vuity®, Pilo hereafter) in the 14-day, phase 3, randomized, double-masked, VIRGO study.MethodsParticipants (40‒55 years) with objective/subjective evidence of presbyopia impacting daily activities, mesopic (10-11 lux at target), high-contrast, binocular distance-corrected near visual acuity (DCNVA) of 20/40‒20/100, and pupil diameter 50 years of age, and 78.3% were emmetropes.On day 14, the mean (SD) change in mesopic pupil diameter (mm) from a baseline of 4.37 (0.82) was -2.15 (0.95), -1.77 (0.91), -1.23 (0.85), -2.17 (0.90), and -1.86 (0.87) at Hours 1, 3, 6, 7, and 9, respectively.Similarly, the mean (SD) change in mesopic DCNVA (letters) from a baseline of 31.9 (8.9) was 12.8 (7.3), 10.3 (7.2),..."

Ophthalmology

Twice- Vs Once-Daily Pilocarpine HCl 1.25% for Presbyopia: Safety Profiles from Randomized, Masked, Controlled, Prospective, Phase 3 Studies (ASCRS-ASOA 2023) - "Purpose To report key safety results from the phase 3 VIRGO study of pilocarpine hydrochloride 1.25% ophthalmic solution (Vuity®, Pilo hereafter) administered bilaterally, twice daily (BID, 6 hours apart) for 14 days in participants with presbyopia, in comparison with once-daily administration bilaterally for 30 days in the pooled phase 3 GEMINI studies.MethodsIn VIRGO, participants (40‒55 years) with evidence of presbyopia impacting daily activities and mesopic, high-contrast, binocular (HCB) distance-corrected near visual acuity (DCNVA) 20/40‒20/100 were randomized to Pilo (N=114) or vehicle (N=116).Individuals with retinal findings at screening on dilated fundoscopy were excluded.Safety measures: treatment-emergent adverse events (TEAEs); intraocular pressure (IOP); mesopic/photopic HCB corrected distance visual acuity (CDVA); slit-lamp biomicroscopy; and dilated fundoscopy.Key safety measures were similar in the GEMINI studies (Pilo, N=375; vehicle, N=374).In..."

Clinical • P3 data • Ophthalmology • Pain • Retinal Disorders

Google Search Trends to Assess Public Interest and Concern Related to Vuity for Presbyopia (WEC 2023) - "Purpose: To understand public awareness, interest, and concerns regarding Vuity (1.25% pilocarpine), an eye drop for presbyopia, based on Google Trends. We used Google Trends to evaluate searches for Vuity in the United States. Since the approval of Vuity on October 29, 2021, notable increases in the relative search volumes occurred for Vuity in October 2021, December 2021, and from March to April 2022, which coincided with its approval, availability, and subsequent direct-to-consumer advertising. Google Trends is a useful tool for monitoring public interest in Vuity. Public concerns regarding side effects warrant further real-world investigations of the causal relationship between Vuity and retinal detachment."

Ophthalmology • Retinal Disorders

"@Allergan #Botox #Vuity #Restasis revenue to cover #Humira's $20 bln shortfall isn't possible, because generics competition in arthritis, eye, cosmetic, and CNS areas and #Skyrizi #Rinvoq lackluster performance make @abbvie $ABBV stock to fall min 20% & max 50% from current $154" (@VVurimindi)

Immunology • Rheumatology