WHAT’S NEW IN CATARACT AND REFRACTIVE SURGERY
Bruder released the Bruder Sx Pre-Surgical Patient Prep Kit for use before corneal surgery, particularly cataract surgery. The kit includes Bruder Hygienic Eyelid Cleansing Wipes, Bruder Hygienic Eyelid Solution (0.02% pure hypochlorous acid) and the The Bruder Sx Pre-Surgical Compress.
Harrow Health acquired AMP-100, a patented topical intraoperative anesthetic pain medication that provides ocular surface anesthesia during ophthalmic interventions such as cataract surgery and intravitreal injections, from Sintetica S.A. The FDA accepted the new drug application filing for AMP-100 in February 2022 and assigned the application standard review and a Prescription Drug User Fee Act target action date of Oct. 16, 2022.
Heine launched its newest indirect ophthalmoscope, the Omega 600. This device includes a lightweight design that utilizes an ultralight battery and features Heine’s vision-BOOST technology to improve retina exams for cataract patients. The Omega 600 is now available in the United States and Canada.
Johnson & Johnson Vision received FDA approval for the TECNIS Eyhance and TECNIS Eyhance Toric II IOLs for the treatment of cataract patients. The company also launched the VERITAS Vision System, a phacoemulsification system with Hybrid Fluidics Technology that minimizes post-occlusion surge.
Salvat completed Phase 3 clinical trials on its drug for the treatment of ocular inflammation and pain after cataract surgery. The treatment is reported to increase tolerability, easily reach the entire eye, prevent blurred vision and improve comfort.
IN THE NEWS
Alcon launched the Clareon family of IOLs in the United States. The IOLs deliver consistent visual outcomes and continuous clarity in a glistening-free IOL material. IOLs in the Clareon family includes: Clareon Monofocal, Clareon PanOptix and Clareon Vivity IOLs. Clareon Toric will be available later this year.
DORC International launched EVA NEXUS for efficiency and control in retina, cataract and combined surgery. Some features include: SmartIOP combined with EquiPhaco technology for anterior surgery; EVA INICIO for precise, ± 1psi control of sub 1ml injections with complimentary cannula systems for sub-retinal injections; and EVA AVETA with a push-fit, Hi-Flow infusion connection.
The FDA accepted LENSAR’s 510(k) submission for its next-generation ALLY Adaptive Cataract Treatment System for substantive review. ALLY is designed to improve surgical workflow, ensure less energy is delivered to the eye and significantly reduce cataract surgery times. The company plans to submit an additional 510(k) application seeking clearance for the phacoemulsification features within the ALLY system later in 2022.
Genentech received FDA approval for Vabysmo (faricimab-svoa) for the treatment of neovascular AMD and diabetic macular edema. Vabysmo targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).
Théa completed its acquisition of seven branded ophthalmic products from Akorn — Zioptan, AcellFX, Betimol, Cosopt, Cosopt PF, AzaSite and Akten — expanding its presence into the US eye-care industry. Additionally, Théa filed its first new drug application with the FDA for a version of the glaucoma treatment latanoprost.
Quantel Medical, a fully-owned subsidiary of the Lumibird Group, launched the C.STIM IPL system to treat dry eye disease. The system is based on intense pulsed light technology and provides a safe and effective treatment for phototypes 1 to 5. Some of the features of the C.STIM IPL include: an ergonomic design for ease of use, an intuitive interface with large HD screen, a handpiece with integrated water-based cooling for precise treatment and a trolley with multiple storage areas.
The FDA approved the first generic version of Restasis (Allergan). Mylan Pharmaceuticals is the sponsor of the approved generic cyclosporine ophthalmic emulsion 0.05% single-use vials.