Glaucoma is an eye disease that damages the optic nerve, with the main cause being ocular hypertension due to high resistance to the outflow of aqueous humor.
The American Academy of Ophthalmology (AAO) annual meeting in Chicago Sept. 30 to Oct. 3 covered the waterfront in the ophthalmic market, with positive signs for continued or improving health as supply kinks work out. Hurricane Ian’s impact on the other side of the country was also a topic, as Florida accounts for a disproportionate percentage of cataract surgeries, which may be delayed as a result of the destruction in the state. We provide some highlights from the conference, analysts’ meetings with company executives and some timely new developments in the sector.
The U.S. FDA approved Santen Pharmaceutical Co. Ltd.’s and UBE Industries Ltd.’s Omlonti (omidenepag isopropyl) ophthalmic solution for reducing elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. It is the second FDA-approved product from Japan-based Santen in the last 15 months for patients in the U.S. with vision conditions.
A new technique may allow reduction of intraocular pressure (IOP) associated with glaucoma without opening the anterior eye chamber, eliminating much of the risk associated with current glaucoma procedures. The cilio-scleral inter-position device (CID) facilitates outflow without creating an artificial egress using a thin one-piece implant.
Abbvie Inc. and Istar Medical SA inked a deal to develop and commercialize Istar’s Miniject device to treat patients with primary open-angle glaucoma. The minimally invasive glaucoma surgical (MIGS) device won CE mark approval in November and has been available in some European countries since early 2022.
Less than two years on from its formation, central nervous system diseases specialist Accure Therapeutics SL has landed a $1 billion-plus agreement to out-license the lead program ACT-01, a first-in-class molecule with neuroprotective properties that is in a phase IIa study in acute optic neuritis. Taking on ACT-01 is ophthalmology specialist Oculis SA, which once it has positive data from the phase IIa, intends to expand to broader indications, including glaucoma and geographic atrophy.
With a round of conference presentations and a new marketing program launched this week, Sight Sciences Inc. kicked off a focused effort to increase awareness of its Omni surgical system’s FDA clearance for glaucoma procedures performed independently of cataract surgery. The coordinated push aims to further boost revenues, which saw an estimated 65% increase compared to 2020 and 12% increase quarter-on-quarter, based on preliminary fourth quarter and fiscal year 2021 results.
Glaukos Corp. received a green light from the FDA for its Iprime device for the delivery of viscoelastic fluid during ophthalmic surgery, which could help the company to recover some of the revenue lost by cuts to reimbursement for its minimally invasive glaucoma surgery (MIGS) product, Istent. A launch date has not been announced.
Israeli startup Ophthalmic Sciences Ltd. is targeting 2023 for regulatory clearance of its artificial intelligence (AI)-based contactless intraocular pressure (IOP) measuring device, IO Perfect. The technology, which combines AI visual analysis in a virtual reality headset, enables remote monitoring of glaucoma. The device is designed to be used at home, in eye clinics, emergency room departments, pharmacies and primary physician settings.
LONDON – The first commercial implantations of Istar Medical SA’s minimally invasive Miniject supraciliary glaucoma drainage device have taken place in Germany, following European CE approval for the product.