Qlosi (pilocarpine low dose) / Orasis Pharma - LARVOL DELTA

Orasis Pharmaceuticals and Aspen Australia announced that Aspen has submitted a New Drug Application in Australia to the Therapeutic Goods Administration (TGA) for the review and approval of BESKA (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults (known as QLOSI in the US market). (Yahoo Finance) - "Aspen will be responsible for the distribution and marketing of BESKA in Australia."

Filing • Ophthalmology

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

Journal • Ophthalmology

Effect of 0.4% and 2% pilocarpine on the pupil, lens, and ciliary muscle accommodative response in presbyopes (ARVO 2026) - "Conclusions Pilocarpine has a dose-dependent effect on pupil diameter. Pilocarpine 2% produces a small residual lens accommodative effect, with a statistically significant change in ciliary muscle that is not observed in the control or pilocarpine 0.4% groups."

Ophthalmology • Retinal Disorders

Aceclidine (Vizz) for presbyopia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Ophthalmology

Quality of Life in Presbyopic Patients Who Are Treated With Qlosi (clinicaltrials.gov) - P4 | N=36 | Recruiting | Sponsor: Southern College of Optometry

HEOR • New P4 trial • Dry Eye Disease • Ophthalmology

Orasis Pharmaceuticals’ prescription pilocarpine hydrochloride ophthalmic solution 0.4% (Qlosi) for presbyopia available in the US (Optometry Times) - "Orasis Pharmaceuticals announced that its novel corrective eye drop for the treatment of presbyopia in adults (Qlosi; pilocarpine hydrochloride ophthalmic solution 0.4%) is available to prescribe in the US."

Launch US • Ophthalmology

Qlosi - pilocarpine 0.4% ophthalmic solution for presbyopia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Ophthalmology

Combination Low-Dose Pilocarpine/Diclofenac Sodium and Pilocarpine Alone for Presbyopia: Results of a Randomized Phase 2b Clinical Trial. (PubMed, Clin Ophthalmol) - "CSF-1 demonstrated significant improvements in mesopic DCNVA and favorable safety. Pilocarpine HCl as a single active ingredient, at the concentration of 0.4% (CSF-1), provided a transient, therapeutic effect for presbyopia."

Clinical • Journal • P2b data • Ophthalmology • CSF1

Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials. (PubMed, Clin Ther) - P3 | "CSF-1, a low-dose pilocarpine ophthalmic solution, demonstrated superiority to vehicle in improving near vision in individuals with presbyopia without compromising distance vision. CSF-1 demonstrated a favorable safety profile."

Journal • P3 data • Ophthalmology • CSF1

Orasis Pharmaceuticals Announces FDA Approval of QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia (PRNewswire) - "Orasis Pharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has approved QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. QLOSI is expected to be commercially available in the U.S. in the first half of 2024....The FDA approval is based on results from the Phase 3 NEAR-1 and NEAR-2 clinical trials..."

NDA • Ophthalmology

An Evaluation of the Safety of CSF-1 in Presbyopic Subjects (clinicaltrials.gov) - P3 | N=178 | Completed | Sponsor: Orasis Pharmaceuticals Ltd. | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology

An Evaluation of the Safety of CSF-1 in Presbyopic Subjects (clinicaltrials.gov) - P3 | N=178 | Active, not recruiting | Sponsor: Orasis Pharmaceuticals Ltd. | Recruiting ➔ Active, not recruiting | N=495 ➔ 178 | Trial completion date: Jul 2023 ➔ Dec 2022 | Trial primary completion date: Jul 2023 ➔ Dec 2022

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

An Evaluation of the Long-Term Safety of CSF-1 in Presbyopic Subjects (clinicaltrials.gov) - P3 | N=495 | Recruiting | Sponsor: Orasis Pharmaceuticals Ltd.

New P3 trial • Ophthalmology