In Brief

Orasis Pharmaceuticals announced that the FDA approved QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. QLOSI is a prescription eye drop that can be used daily, or as needed, up to twice per day. QLOSI has demonstrated efficacy 20 minutes after administration and can last up to 8 hours, as measured on day 15, to improve near vision without impacting distance or night vision, the company says. QLOSI is expected to be commercially available in the first half of 2024.

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.

Théa Pharma announced the launch of IYUZEH (latanoprost ophthalmic solution) 0.005% in the US market. IYUZEH is the first preservative-free latanoprost for patients with primary open-angle glaucoma and ocular hypertension in the United States. IYUZEH is available through authorized distributors and the following wholesalers and order numbers: ABC (10282592), ANDA (603442), Cardinal (5865035), McKesson (2849651) and NDC (82584-003-30).

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. Bausch + Lomb also launched LUMIFY EYE ILLUMINATIONS, a new line of hypoallergenic specialty eye-care products.

Also, Bausch + Lomb announced the launch of the enVista Aspire monofocal and toric intraocular lenses (IOLs) with Intermediate Optimized optics. enVista Aspire is designed for a broad depth of focus and allows for a range of vision beyond one focal point. Similar to the company’s enVista MX60E, enVista Aspire offers a glistening-free optic material and its proprietary StableFlex technology, which is designed to aid in optic recovery.

The Centers for Medicare & Medicaid Services assigned a permanent and product-specific J-code (J2781) for Apellis Pharmaceuticals’ SYFOVRE (pegcetacoplan injection), the first-ever treatment for geographic atrophy secondary to age-related macular degeneration. The J-code for SYFOVRE became effective on Oct. 1, 2023.

Ocuphire Pharma and Viatris Inc. announced the FDA approved RYZUMVI (phentolamine ophthalmic solution) 0.75% eyedrops for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (eg, phenylephrine) or parasympatholytic (eg, tropicamide) agents. RYZUMVI is expected to be commercially available in the United States in the first half of 2024.

Heidelberg Engineering received FDA clearance for its Anterion platform, which the company says is designed to improve anterior segment diagnostics and streamline practice workflow. Anterion combines biometry, IOL power calculation with corneal topography and tomography, anterior chamber metrics, and high-resolution imaging. Additional proprietary features include patented eye tracking and composite imaging technologies.

NeoLight announced FDA Class 2 clearance for ICON GO, its portable ophthalmic retinal imaging system with expanded fluorescein angiography capabilities. The system is designed to provide sharp retinal imaging quality across diverse patient care environments such as pediatric and neonatal intensive care units, operating rooms and emergency rooms.

Altris received FDA 510(k) clearance for its image and data management platform, Altris IMS. The platform is designed to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including patient data, diagnostic data, clinical images and information, reports and measurement of DICOM-compliant images. It is also indicated for manual labeling and annotation of retinal optical coherence tomography scans.

NovaBay Pharmaceuticals announced the US commercial launch of Avenova Allograft through its physician-dispensed channel. This prescription product is the first optic allograft manufactured using BioStem Technologies’ proprietary process and is intended for use as a protective covering during the repair of ocular surfaces. It consists only of the amnion layer of the placental membrane and measures between 20-50 microns thick.

Tarsus Pharmaceuticals’ XDEMVY (lotilaner ophthalmic solution) 0.25% is now available at pharmacies nationwide for prescription. The FDA approved XDEMVY on July 24 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. OP