• Orasis Pharmaceuticals submitted a new drug application (NDA) to the FDA for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%), a novel corrective eyedrop candidate being investigated for the treatment of presbyopia. The NDA is based on data from the Phase 3 NEAR-1 and NEAR-2 clinical trials, involving more than 600 patients, which evaluated the efficacy and safety of CSF-1. Both trials met their primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity and no loss of 1-line or more in distance visual acuity.

• Kala Pharmaceuticals announced the FDA accepted an investigational new drug (IND) application for the company’s lead product candidate, KPI-012, a human mesenchymal stem cell secretome, initially in development for the treatment of persistent corneal epithelial defect (PCED). The company is on-track to initiate a Phase 2b trial in 1Q 2023 that will evaluate the safety and efficacy of two doses of KPI-012 ophthalmic solution compared to vehicle when dosed topically four times per day for 56 days. The trial is expected to enroll approximately 90 adult patients with PCED, and the primary endpoint of the trial will be complete healing of the PCED as measured by corneal fluorescein staining.

• Opus Genetics acquired the rights to two preclinical-stage AAV-based gene therapy product candidates for inherited retinal diseases from Iveric Bio. Opus will develop the novel gene therapy candidates to address bestrophin-1 (BEST1)-related inherited retinal diseases and rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP), respectively. Opus will also assume responsibility for the global research, development and commercialization of BEST1 and RHO-adRP programs. Opus anticipates completing additional IND-enabling studies and filing an IND for BEST1 in the second half of 2023.

• Harrow announced the availability, for in-office use, of Fortisite (compounded tobramycin 1.5% + vancomycin 5%) from its FDA-registered and FDA-inspected ImprimisRx 503B outsourcing facility. Fortisite formulations are patent-pending high-concentration, refrigeration-stable, fortified antibiotic formulations, in solution. The availability of Fortisite for in-office use represents the first time physicians have been able to stock a fortified or high-concentration compounded antibiotic formulation for the immediate treatment of patients in need. ImprimisRx offers a Fortisite patient access program and a 100% replacement guarantee for any expired 503B Fortisite product.

• Compulink Healthcare Solutions, a company that specializes in specialty specific all-in-one EHR solutions, has achieved the Office of the National Coordinator for Health Information Technology (ONC-Health IT) 2015 Edition Cures Update Health IT certification, which goes into effect in 2023. This includes the latest interoperability standards needed to support compliance with the 21st Century Cures Act information-sharing requirements.

• Bausch + Lomb announced the US launch of “Screen, Protect, Cure,” a campaign designed to provide educational resources and raise awareness of glaucoma during Glaucoma Awareness Month. During January, Bausch + Lomb and Glaucoma Research Foundation (GRF) will share educational resources to educate individuals who may be at risk for glaucoma and empower them to take an informed and active role in their eye health. The campaign also features a fundraising challenge that will match every dollar raised up to $20,000 in support of GRF research for a potential cure for glaucoma. People interested in participating in the fundraising challenge or testing their knowledge about glaucoma can take an interactive quiz and learn more at glaucoma.org/screen-protect-cure.

• As part of January’s National Glaucoma Awareness Month, Prevent Blindness is offering a variety of free resources. These include “The Glaucoma Community” that provides users with a toolkit of community-oriented features, along with a dedicated Facebook page; and the Prevent Blindness dedicated webpage, PreventBlindness.org/glaucoma, that provides information on glaucoma, a variety of downloadable fact sheets and a new resource, “Glaucoma Financial Assistance Information.” Also, as part of the Prevent Blindness Focus on Eye Health Expert Series, patients and their caregivers can watch the Understanding Glaucoma” episode. Lastly, Prevent Blindness is offering the newly updated Living Well With Low Vision resource, designed for patients, caregivers and health-care professionals.

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.