IN THE NEWS

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.

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 (GA) secondary to AMD. The J-code for SYFOVRE became effective on Oct. 1, 2023.

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.

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.

Harrow changed its corporate name from “Harrow Health, Inc.” to “Harrow, Inc.” The company say the change aligns with its current 5-year strategic plan, which includes an exclusive focus on eye-care pharmaceuticals.

Iveric Bio, an Astellas company, reported positive 24-month topline results from the Phase 3 GATHER2 clinical trial evaluating the efficacy and safety of IZERVAY (avacincaptad pegol intravitreal solution), a complement C5 inhibitor for the treatment of GA secondary to AMD. Topline results demonstrated that the IZERVAY monthly dosing regimen met the primary objective to significantly slow GA growth compared to sham at 24 months.

Alphaeon Credit announced a strategic alliance with iOR Partners that offers vision providers exclusive financing rates and enhances the in-office surgery experience for patients. According to the announcement, iOR provider partners will benefit from special AC rates; enhanced credit limits and approval rates where Alphaeon’s offerings will be available to iOR provider partners; and a revolving line of credit as part of the partnership.

Novartis discontinued the development of its GA gene therapy candidate GT005 (PPY988). The company says 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.

ZEISS Medical Technology and Boehringer Ingelheim announced a long-term strategic collaboration to develop predictive analytics to enable early detection of eye diseases and more personalized treatments to prevent vision loss for people with serious eye diseases.