• Bausch + Lomb and Novaliq GmbH announced American Journal of Ophthalmology published results from MOJAVE, the second pivotal Phase 3 trial for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease associated with meibomian gland dysfunction. Second pivotal Phase 3 data showed least-squares mean change from baseline to Week 8 was statistically significantly greater for NOV03 compared with saline for both total corneal fluorescein staining and visual analog scale dryness score, with statistically significant between-group differences observed as early as Week 2. The incidence of ocular adverse events was similar for NOV03 (12.9%) and saline (12.3%). Results from the first pivotal Phase 3 trial, GOBI, were published earlier this year in Ophthalmology. The FDA assigned NOV03 a Prescription Drug User Fee Act action date of June 28, 2023. For more, see the study results here.

• The CDC reported more cases of vision loss and death due to the extensively drug-resistant strain of Pseudomonas aeruginosa found in some artificial tears and urged patients to stop using EzriCare or Delsam Pharma’s Artificial Tears pending additional information and guidance from the CDC and FDA. As of March 14, 2023, CDC, in partnership with state and local health departments, identified 68 patients in 16 states (CA, CO, CT, FL, IL, NC, NJ, NM, NY, NV, PA, SD, TX, UT, WA, WI) with VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa. Thirty-seven patients were linked to four health-care facility clusters. Three people have died, and there have been eight reports of vision loss and four reports of enucleation. Most patients reported using artificial tears. Patients reported over 10 different brands of artificial tears, and some patients used multiple brands. EzriCare Artificial Tears packaged in multidose bottles, was the brand most commonly reported. Laboratory testing by CDC also identified the presence of VIM-GES-CRPA in opened EzriCare bottles from multiple lots. Read the full statement here. 

• Visus Therapeutics completed patient enrollment and the last visit has been conducted in BRIO-I, a pivotal Phase 3 trial for its lead asset, BRIMOCHOL  PF, a novel, preservative-free topical ophthalmic solution for the treatment of presbyopia. BRIMOCHOL PF is fixed-dose combination of carbachol and brimonidine tartrate that produces a robust and sustained “pinhole effect” by reducing the size of the pupil. This allows only the light rays focused on the retina to enter the eye, thereby sharpening vision. The result is an enhanced and durable clarity of vision for near tasks, like reading or using a smartphone, and intermediate tasks, such as looking at a computer screen. BRIO-I is a double-masked, randomized, multi-center, safety and efficacy study that enrolled emmetropic phakic and pseudophakic presbyopic subjects.

• Aviceda Therapeutics submitted an investigational new drug (IND) application to the FDA. The IND supports the use of its lead intravitreal ocular asset, AVD-104 (a novel glycan-coated nanoparticle), for the treatment of geographic atrophy secondary to AMD. Aviceda previously announced the successful completion of IND-enabling Good Laboratory Practice toxicity studies that showed positive safety data for multiple well-tolerated doses of AVD-104. This included dose-range finding studies in non-human primates and rabbits to support continued development and the initiation of human clinical trials. 

• NovaBay Pharmaceuticals announced the launch of OTC Avenova Eye Health Support oral supplement featuring a combination of MaquiBright, a nutrient-rich, antioxidant-dense extract of the superfruit maqui berry, and natural triglyceride omega-3 oils to comfort dry eyes and support overall eye health. Avenova Eye Health Support is sold as 60 softgel capsules (30-day supply) and is available at Amazon.com and Avenova.com for $41.95 and through optometrist offices participating in NovaBay’s physician-dispensed channel. Participants in a four-week, randomized, double-blind, placebo-controlled study on the effects of MaquiBright extract showed an 89% increase in tear production and reported a 57% improvement in dry eye discomfort with Avenova Eye Health Support. 

• The American Diabetes Association (ADA) and Genentech, a member of the Roche Group, announced a new partnership as part of the ADA’s Health Equity Now work to tackle access to screening and treatment for eye diseases that affect the diabetes community. The programming will kick off with a pilot in Birmingham, Ala., in collaboration with community partners to conduct focus groups with African Americans to understand the barriers to eye health in under-resourced communities and provide resources — including education and screenings — to address these barriers.

• Researchers at the University of Alabama at Birmingham discovered that night vision tests at a specific location in the retina will be suitable for assessing treatments and preventions for AMD. The Alabama Study on Early Age-related Macular Degeneration (ALSTAR2), prospectively assessed more than 500 persons over 3 years to determine the best vision test for signaling disease onset and worsening. The study shows that rod photoreceptors next to the fovea are few in number but are stronger indicators than the more numerous rods farther away. Learning that slowing is worse near the fovea links vision changes to specific cellular mechanisms. Whether dark adaptation slowing predicts disease progression will be learned from the ongoing 3-year follow-up visit of ALSTAR2. For more, see the study results here.

• Kuria Therapeutics completed a pre-IND interaction with the FDA and received positive feedback on its development program for KTX-1161 for corneal endothelial disease. KTX-1161 is a topical ophthalmic solution formulation of SCO-116, a novel Nrf2 activator being developed under a license from SCOHIA PHARMA. Kuria is developing KTX-1161 to treat patients with diseases of the corneal endothelium, including patients with Fuchs’ endothelial corneal dystrophy and patients undergoing cataract surgery.

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.