• The FDA approved Regeneron Pharmaceuticals’ EYLEA HD (aflibercept) Injection 8 mg for the treatment of patients with wet AMD, diabetic macular edema (DME) and diabetic retinopathy (DR). The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) every 4 weeks (monthly) for the first 3 months across all indications, followed by 8 mg every 8 to 16 weeks (2 to 4 months) in wet AMD and DME and every 8 to 12 weeks (2 to 3 months) for DR. The FDA approval is based on the pivotal PULSAR and PHOTON trials in which EYLEA HD demonstrated clinically equivalent vision gains to EYLEA (aflibercept) Injection 2 mg that were maintained with fewer injections.

• Tarsus Pharmaceuticals announced that XDEMVY (lotilaner ophthalmic solution) 0.25% is now available at pharmacies nationwide for prescription. The FDA approved XDEMVY on July 24, 2023, for the treatment of Demodex blepharitis. It is the only FDA-approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis. XDEMVY is a prescription eyedrop that is administered with one drop in each eye twice daily (approximately 12 hours apart) for 6 weeks. Tarsus developed Tarsus Connect, a suite of assistance programs that provide financial support for eligible patients. More information about Tarsus Connect can be found on xdemvy.com or by calling: 1-866-846-3092.

• Apellis Pharmaceuticals provided an update on SYFOVRE injection kits supplied by Apellis. As part of the comprehensive investigation into the real-world safety events, internal structural variations were identified in the specific 19-gauge x 1½ inch filter needle included in certain injection kits. A causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis in the real world, but the company recommends that practitioners immediately discontinue use of any injection kits that contain the 19-gauge filter needle and use injection kits with the 18-gauge filter needle, which are already in distribution. While injection kits previously contained one of two types of filter needles (either 18- or 19-gauge), Apellis is now exclusively distributing injection kits with the 18-gauge filter needle. For more information, and an update on the rare events of retinal vasculitis reported in real-world treatment with SYFOVRE (pegcetacoplan injection) for geographic atrophy secondary to AMD, click here.

• Bausch + Lomb announced expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976, as amended, with respect to the previously announced agreement to acquire XIIDRA (lifitegrast ophthalmic solution) 5%, a non-steroid eyedrop specifically approved to treat the signs and symptoms of dry eye disease focusing on inflammation associated with dry eye, and certain other ophthalmology assets. Expiration of the HSR Act waiting period occurred on Aug. 23, 2023. Completion of the transaction is expected to occur at or around the end of September, subject to satisfaction of the remaining customary closing conditions.

• The FDA is warning consumers not to purchase and to immediately stop using Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops - Eye Repair due to bacterial contamination, fungal contamination, or both. Dr. Berne’s products are distributed by Dr. Berne’s Whole Health Products; LightEyez’ products are distributed by LightEyez Limited. The FDA recommends consumers properly discard these products as the FDA describes. Using contaminated eyedrops could result in minor to serious vision-threatening infection, which could possibly progress to a life-threatening infection. The FDA is not aware of any adverse event reports associated with use of either products at this time. Patients who have signs or symptoms of an eye infection should talk to their health-care professional or otherwise seek medical care immediately. The Dr. Berne’s and LightEyez eyedrop products also contain methylsulfonylmethane (MSM) as an active ingredient. These products are unapproved drugs and illegally marketed in the United States. There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient. The FDA conducted sampling and testing based on these products’ intended use in the eyes, which showed the products were contaminated with microbes and were not sterile. Dr. Berne verbally agreed on Aug. 21, 2023, to voluntary recall the Dr. Berne’s MSM Drops 5% Solution. However, LightEyez Limited has not responded to the FDA or taken action to protect consumers. Read the FDA’s full statement here.

• Amber Ophthalmics announced that Dr. Mark S. Gorovoy from Gorovoy M.D. Eye Specialists enrolled the first patient in the AMB-01-006 (NEXPEDE-1) study, a randomized, double-masked, vehicle-controlled Phase 2/3 clinical trial designed to evaluate two concentrations of Nexagon (lufepirsen ophthalmic gel) for the treatment of persistent corneal epithelial defects (PCED). The study evaluates the safety and efficacy of Nexagon, in a dosing regimen that utilizes as few as five topical in-office administrations for subjects with confirmed non-infectious PCED. Subjects who do not re-epithelialize within the first 4 weeks of treatment will continue to receive weekly administrations until subjects either achieve re-epithelialization or complete 8 weeks of therapy. The primary endpoint for the NEXPEDE-1 study will be complete corneal healing as determined by corneal fluorescein staining.

• A new study by researchers from the University College London and Moorfields Eye Hospital found that eye scans can detect signs of Parkinson’s disease up to 7 years before diagnosis. The study, published in Neurology, identified markers of Parkinson’s in eye scans with the help of artificial intelligence. Its analysis of the AlzEye dataset was repeated using the wider UK Biobank database (healthy volunteers), which replicated the discoveries. The use of these two datasets has enabled the team to identify these subtle markers, even though Parkinson’s disease has a relatively low prevalence. The study confirmed previous reports of a significantly thinner ganglion cell-inner plexiform layer, while for the first time finding a thinner inner nuclear layer. It further found that a reduced thickness of these layers was associated with increased risk of developing Parkinson’s disease, beyond that conferred by other factors or comorbidities. For more, see the study results here.

• Scientists have discovered an external protein network that can help stabilize neural connections. The Noelin family of secreted proteins bind to the external portion of AMPA glutamate receptors and stabilize them on the neuronal cellular membrane, a process necessary for transmission of full-strength signals between neurons, according to a study in mice from the National Eye Institute and the University of Freiberg. Without this external, stabilizing protein network, the AMPA receptors are no longer retained at the synapse, leading to weak, short-lived synaptic signals. The findings not only provide insight into processes such as learning and memory, but also the development of blinding conditions such as glaucoma. The study was published in the journal Neuron. For more information, see the study results here. 

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.