• Bausch + Lomb announced the US commercial launch of MIEBO (perfluorohexyloctane ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO is the first prescription eyedrop approved for DED that directly targets tear evaporation. MIEBO is a single ingredient, water-, preservative- and steroid-free prescription eyedrop designed to address the signs and symptoms of DED by reducing tear evaporation at the ocular surface. The FDA approved MIEBO in May 2023, based on consistent results from two pivotal Phase 3 trials. Its clinical development program includes the first and only Phase 3 program for any FDA-approved prescription DED product composed entirely of patients with both DED and clinical signs of meibomian gland dysfunction.

• Novartis announced it discontinued the development of its geographic atrophy gene therapy candidate GT005 (PPY988), which it acquired though the acquisition of Gyroscope Therapeutics. The decision was based on a recommendation from the independent Data Monitoring Committee following an overall benefit risk assessment of available data from the program studies, which concluded futility criteria had been met. No new safety signals were identified. While Novartis has discontinued the program studies, the company says it is committed to ensuring patients treated with GT005 (PPY988) are provided with long-term safety follow up.

• The FDA issued warning letters to eight companies — Boiron Inc., CVS Health, DR Vitamin Solutions, Natural Ophthalmics, Inc., OcluMed LLC, Similasan AG/Similasan USA, TRP Company, Inc. and Walgreens Boots Alliance, Inc. — for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law. These warning letters are part of the agency's ongoing effort to protect Americans from potentially harmful ophthalmic products. Eye products addressed in the eight warning letters are illegally marketed to treat conditions such as conjunctivitis, cataracts, glaucoma and others. Some of the FDA warning letters also cite the companies involved for quality issues related to product sterility. Some of these eye products are labeled to contain silver, which may be characterized as silver sulfate, silver sulphate or argentum. Long-term use of drugs containing silver can cause some areas of the skin and other body tissues, including in the eye, to permanently turn gray or blue-gray. Consumers currently using eye products included in these warning letters are asked to speak to their health-care professional. The FDA encourages consumers and health-care professionals to report any adverse reaction to the agency's MedWatch program.

• The International Agency for the Prevention of Blindness (IAPB) announced that Johnson & Johnson Vision joined the global eye health body as a Band A Member. Johnson & Johnson Vision and the IAPB will focus on advocating for better eye health around the world. In addition, Johnson & Johnson Vision has joined the Love Your Eyes campaign by becoming World Sight Day Global Partners. This year, World Sight Day activities, which are coordinated by IAPB, its global partners and members, will spotlight the world of work under the theme of “Love Your Eyes at Work” emphasizing the critical importance of prioritizing eye health on employee productivity, safety and overall well-being.

• NovaBay Pharmaceuticals and BioStem Technologies announced an agreement under which NovaBay has been granted the right to commercialize BioStem Technologies’ Amniotic Tissue Allograft, which is intended for use as a protective covering during the repair of ocular surfaces. Amniotic Tissue Allograft provides a protective environment or covering for repair of the cornea and conjunctiva, helping ocular surface to return to a healthier state. NovaBay intends to commercialize the prescription-only product as Avenova Allograft to leverage its Avenova eye-care brand and encourage use with other Avenova products. Medically necessary procedures with the Avenova Allograft will be reimbursed through Medicare.

• Amgen and Horizon Therapeutics announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This clears the path to take the final steps to close Amgen's acquisition of Horizon. Amgen and Horizon expect that the parties will jointly file stipulated proposed orders to dismiss the preliminary injunction motion and dissolve the temporary restraining order in the U.S. District Court for the Northern District of Illinois, and that Amgen and Horizon will quickly seek the final approvals required under Irish law to close the acquisition. Amgen has consistently stated to the FTC, the courts and the public that it has no reason, ability or intention to bundle Horizon's TEPEZZA (teprotumumab-trbw) or KRYSTEXXA (pegloticase injection) with any of its products. The companies anticipate being able to close the acquisition in early fourth-quarter 2023.

• Alcon revealed final data from its Vivity Registry Study, which monitored real-world patient experiences for up to 12 months post cataract surgery with implantation of either AcrySof IQ Vivity or AcrySof IQ Vivity Toric presbyopia-correcting IOL. Data from more than 900 cataract patients demonstrated sustained clinical performance, high patient satisfaction and reduced dependence upon spectacles. Researchers also concluded that: Three-quarters of patients reported no difficulty with their sight for activities in everyday life, 92% reported they were satisfied with their sight, and more than 91% of patients reported no halos, glares or starbursts. For more, see the study results here.

• Lumibird finalized the acquisition of Convergent Photonics following the lifting of all conditions precedent and in particular the obtaining of regulatory approvals. The new subsidiary, named “Lumibird Photonics Italia,” is based in Turin, Italy. The Convergent assets held by Prima Industrie North America are taken over by Lumibird Photonics USA (formerly Quantel USA). This acquisition has a double strategic interest for Lumibird by strengthening its autonomy in semiconductors and high-power fiber laser technologies and by opening up new market segments. The arrival of semiconductors also complements the strategic investments already made in fiber optics and related components. 

• OKYO Pharma Limited announced it completed full enrollment of patients in the randomized portion of the Phase 2 multi-center, double-masked, placebo-controlled clinical trial of topical ocular OK-101 to treat DED. A total of 240 patients enrolled in the study will randomly be divided into three cohorts of 80 patients. The cohorts include one treated with placebo, a second treated with 0.05% OK-101 and the third receiving 0.1% OK-101. The drug and placebo, respectively, are being administered in both eyes twice daily for 12 weeks. The duration of a patient’s treatment is approximately 14 weeks, including a 2-week run-in period, to address the placebo effect. The Phase 2 trial is designed as a potential registration trial, with pre-specified primary efficacy endpoints covering both a sign and symptom of DED. For more details, click here.

• Myra Vision, a Shifamed portfolio company, initiated its first-in-human clinical study of the Calibreye System, a next generation glaucoma drainage device with titratable outflow control designed to achieve optimal reduction of IOP for moderate to severe glaucoma patients. The prospective, non-randomized open-label feasibility study aims to evaluate the clinical procedure, safety and overall performance of the Calibreye System in open angle glaucoma patients. The system is engineered to put outflow control in the hands of glaucoma specialists, giving them the opportunity to provide personalized therapy while minimizing complications. Once implanted, the Calibreye shunt is designed to allow non-invasive in-office increases or decreases in outflow as a patient’s individual treatment needs change.

• EyePoint Pharmaceuticals announced positive interim masked safety data for its lead product candidate, EYP-1901, from the company’s ongoing trials. This includes the Phase 2 PAVIA trial evaluating EYP-1901 as a potential 9-month treatment for moderately severe to severe non-proliferative diabetic retinopathy and the DAVIO 2 trial as a potential 6-month sustained delivery maintenance treatment for wet AMD. All treatment arms in the PAVIA trial have reached at least 3-months post-dosing follow-up as of Sept. 1, 2023. Approximately 170 patients have received EYP-1901 with a minimum of 3 months of follow-up post injection from the ongoing Phase 2 PAVIA and DAVIO 2 clinical trials and the completed DAVIO 1 trial with no reported drug-related ocular severe adverse events (SAEs) and no reported drug-related systemic SAEs. In the PAVIA clinical trial, there have been no reported drug-related ocular SAEs and no reported drug-related systemic SAEs. 

• A team of scientists from the University of California, Irvine, believe they have discovered a special antibody that may lead to a treatment for retinitis pigmentosa (RP). Their study, “Structural basis for the allosteric modulation of rhodopsin by nanobody binding to its extracellular domain,” was published in Nature Communications. The researchers targeted their study on a specific molecule which they believe will provide a treatment for Rhodopsin-associated autosomal dominant RP (adRP). Rhodopsin is a key light-sensing molecule in the human retina found in rod photoreceptor cells, and mutations in the Rhodopsin gene are a primary cause of adRP. The researchers used a special type of llama-derived antibody, known as a nanobody, that can halt the process of Rhodopsin photoactivation, allowing it to be investigated at high resolution. The scientists discovered that these nanobodies target an unexpected site on the Rhodopsin molecule, near the location where retinaldehyde binds. They also found that the stabilizing effect of these nanobodies can be applied to Rhodopsin mutants that are associated with retinal disease, suggesting their use as therapeutics. 

• Stuart Therapeutics announced the United States Patent and Trademark Office issued U.S. Patent No. 11,684,651, with granted claims for compositions of matter and methods of use in a variety of anterior segment indications in ophthalmology. Stuart now controls a total of 10 granted patents, including five in the United States, with an additional 32 patents currently pending in the United States and other countries. The patents support a growing body of intellectual property supporting the PolyCol platform of Collagen Mimetic Peptide (CMP) therapeutic compounds. This family of peptides is designed to mimic natural collagen fragments, and certain of these peptides have been shown in both pre-clinical testing and clinical trial settings to provide an improvement in diseased and damaged tissues, including those tissues comprising epithelial cells and neuronal cells. The newly granted patent claims expand Stuart's intellectual property in ophthalmic anterior segment diseases and disorders. Stuart is currently developing PolyCol sequences for dry eye disease (entering Phase 3 clinical trials in 4Q, 2023), glaucoma, retinal diseases and disorders, and myopia. 

• Advancements that could lead to earlier diagnosis and treatment for diabetic retinopathy have been identified by a multi-department research team from Michigan State and other universities. Their findings were recently published in Diabetologia. Researchers found that diabetes, age-related health conditions and other metabolic disorders can lead to a buildup of cholesterol in the retina. This tends to crystalize and contribute to the development of diabetic retinopathy. Crystalized deposits are very reflective and can be seen in images of the retina. This is important because noninvasive retina evaluations can be done by most optometrists, creating an opportunity for earlier diagnosis for more people. A researcher from MSU Division of Cardiology, said that these cholesterol crystals are like the crystals found in atherosclerotic plaque that can form in arteries and cause heart attacks, a finding discovered in his lab at MSU. He helped the research team identify ways to scan retinas using modified tissue preparation for scanning electron microscopy.

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.