EYELID SURGERY DEVICE TAKES FIRST PLACE
Winning Pitch Challenge at Eyecelerator provides platform for innovation.
Patricia Buehler, MD, MPH, and co-founder, Knute Buehler, MD, of Bend, Ore.-based Osheru — the company they founded to develop the Ziplyft device for minimally invasive lid surgery — won first place in the Winning Pitch Challenge and a check for $25,000 for Ziplyft during Eyecelerator at ASCRS 2023 in San Diego. Osheru was one of three finalists chosen to pitch live on stage.
“It’s great to have an idea, but it’s really wonderful when people from industry and ophthalmology leaders like Dick Lindstrom, MD, and Jim Mazzo, think it’s a good idea too,” says Dr. Patricia Buehler.
FROM IDEA TO DEVELOPMENT
When performing eyelid surgery, a lot of time is spent on cauterization of bleeding vessels to reduce bruising as well as the suturing process — which is tedious, she says.
To make eyelid surgery a better experience for the patient and the surgeon, Dr. Patricia Buehler took an ancient treatment and modernized it. “I was inspired by an ancient Egyptian medicine exhibit showing how Egyptian healers removed excess lid skin by compressing the skin between two small twigs, depriving it of blood supply — the excess skin fell off within 5 days,” she says.
Impressed by this idea, Dr. Patricia Buehler designed the Ziplyft device (www.ziplyft.com ) and worked with an engineering firm to create it. Ziplyft, a patented FDA Class 1 device, features a clear plastic design allowing the surgeon to see the skin markings of the tissue to be removed. The device fits up against the nasal bone, so it has symmetric placement between the two lids. The guarded blade then runs across and removes that excess skin followed by the use of commercially available tissue glue to seal the incision. The device also eliminates the need for IV sedation, cauterization and suturing.
“Blepharoplasty can normally take up to 60 minutes in a surgery center, but with minimally invasive Ziplyft, excess skin can be removed from the upper lid in 10 minutes in the office,” Dr. Patricia Buehler says. “By using Ziplyft, we are giving surgeons back their time.”
Additionally, she says, the patient minimizes the bruising and swelling they can get for up to 2 weeks after a typical blepharoplasty. “This procedure gives the patient a very natural look with little downtime. Why look bad to look good?”
ENTERING THE WINNING PITCH CHALLENGE
All Winning Pitch Challenge submissions are reviewed by the session moderators and panel of judges. The semi-finalists that advance to Round 2 are matched with a mentor. Applicants then submit a recording of their pitch before three finalists are chosen.
“My mentor, Gary Berman of greyspace, was wonderful,” she says.
After her presentation, Dr. Buehler says she received positive feedback and support from other ophthalmologists. “It’s really been an amazing process to watch all the ophthalmologists get together and support each other to try to bring what’s best for the patient forward. We’re really fortunate in ophthalmology that so many of our colleagues believe in innovation.”
WHAT’S NEXT
Osheru intends to engage six early adopters in Q4 2023 to do a clinical evaluation of 20 patients each. Dr. Buehler says she plans to use the prize money from the Winning Pitch Challenge to help fund this.
For more information, visit www.eyecelerator.com . OM
WHAT’S NEW RETINA
AEYE Health received 510(k) clearance from the FDA to market its diagnostic screening system, the AEYE-DS, for diabetic retinopathy. It can be used with Topcon’s NW-400 desktop retinal camera.
Aldeyra Therapeutics submitted an NDA to the FDA for ADX2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma.
Apellis Pharmaceuticals announced the FDA approval of SYFOVRE (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to AMD. It is the first FDA-approved treatment for GA.
Bausch + Lomb and Modulight Corp. announced the FDA approved the ML6710i photodynamic laser for equivalent use with Bausch + Lomb’s VISUDYNE (verteporfin for injection) photodynamic therapy for the treatment of patients with predominantly classic subfoveal choroidal neovascularization, or the creation of abnormal choroidal blood vessels, due to AMD.
BVI launched CryoTreq, the first handheld, all-in-one, single-use device for cryosurgery. The device provides ophthalmologists with an effective tool to treat certain potentially sight-threatening retinal tears and detachments.
C. Light Technologies announced its device, the Retitrack, the first retinal eye-movement monitor for non-invasive, objective clinical assessments, has been cleared for marketing through premarket notification 510(k) from the FDA.
Focus Vitamins launched new Focus PI (post-injection) eyedrops to provide relief from irritation and dryness from eye injections. The eyedrops are extra viscous with 0.7% hypromellose and offer enhanced lubrication that helps alleviate discomfort in the eyes after injections, including anti-VEGF injections to treat AMD.
The FDA accepted Genentech’s supplemental Biologics License Application for Vabysmo (faricimabsvoa) for treatment of macular edema following retinal vein occlusion.
Iridex Corp. announced the full US market launch of the next-generation Iridex PASCAL laser with MicroPulse. The platform combines fast and precise pattern-scanning capabilities in a smaller integrated laser platform and includes three tissue-sparing technology options.
Optos Plc expanded the optomap ultra-widefield (UWF) retinal imaging modalities available with the California FA device to now include the first UWF color rgb (red/green/blue) image. This new modality is captured simultaneous to the optomap color rg (red/green) image — a single capture delivers two color UWF images.
IN THE NEWS
Bausch + Lomb and Novaliq GmbH announced the FDA approved MIEBO (perfluorohexyloctane ophthalmic solution; formerly known as NOV03), for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO is the first FDA-approved treatment for DED that directly targets tear evaporation.
Cassini launched the Cassini Connect digital cataract surgery suite. Compatible with most leading microscope brands, Cassini Connect provides an integrated cataract surgery workflow and data solution — from preop diagnostics, digital ocular registration and marking to cloud-based surgery planning and intra-op visualization and guidance.
Alimera Sciences announced its acquisition of additional commercialization rights for YUTIQ (fluocinolone acetonide intravitreal insert) 0.18 mg, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, from EyePoint Pharmaceuticals. Alimera will immediately assume control of all commercial activities related to YUTIQ in the United States.
Seenu M. Hariprasad, MD, the Shui-Chin Lee Professor of Ophthalmology, was appointed Chair of the Department of Ophthalmology and Visual Science at the University of Chicago Medical Center. He has been serving as interim chair since 2020. Dr. Hariprasad has served as an investigator in more than 45 national and international retina clinical trials evaluating various medications, sustained drug-delivery devices and surgical innovations.
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