As Johnson & Johnson's (J&J) first-quarter revenue missed Wall Street estimates for medical devices on April 16, CEO Joaquin Duato noted that the company will continue to look for major M&A plays to boost long-term growth in the wake of its recently reported $13.1 billion buy of Shockwave Medical Inc.
The notion of using vacuum pressure on the anterior portion of the human eye as a treatment for open-angle glaucoma might be a clinical novelty, but Balance Ophthalmics Inc. is poised to change that. The company recently won a favorable outcome at a U.S. FDA advisory panel for its Fsyx negative pressure pump for ocular use, although the company is likely to have to drum up a large body of data in post-approval studies, assuming the FDA gives the Fsyx the nod.
The U.S. Department of Justice (DOJ) announced in May 2023 that it had obtained a judgment of more than $487 million against the parent company of Precision Lens for alleged violations of the False Claims Act (FCA), but the amount of that decision has been overturned. In a Feb. 8 decision, the U.S. District Court for the District of Minnesota decreed that the judgment be reduced to less than $217 million, an outcome which suggests that some of the more excessive fines levied against health care companies will be viewed with more skepticism upon appeal.
Spyglass Ophthalmics Inc. is seeking patent protection for intraocular drug delivery devices and methods of delivering therapeutic agents to the eye. The methods include implanting an intraocular implant into the eye and adjacent to a fluid-permeable membrane of the patient’s eye.
Carl Zeiss Meditec AG recently received U.S. FDA clearance for the latest generation of its femtosecond laser, the Visumax 800, with its Smile pro software, for surgically treating nearsightedness, with or without astigmatism.
Ophthalmology company Polyactiva Pty Ltd.’s biodegradable ocular implant provides six months of sustained drug delivery for patients with glaucoma and is the first biodegradable ocular implant that has the potential to be used safely for repeat dosing, Polyactiva CEO Vanessa Waddell told BioWorld.
Ilasis Laser SAS said it raised $4.8 million to finance commercial development in Europe of its femtolaser surgical instrument, Rx. A group made up of French business angels, Irdi Capital investment SAS, and Nouvelle Aquitaine Coinvestiment SAS (NACO) were involved in this funding round.
Luminopia Inc. reeled in $16 million in an oversubscribed series A financing led by U.S. Venture Partners. The funds will support full commercial launch of the company’s U.S. FDA-cleared digital therapeutic for the treatment of children ages 4-7 with amblyopia. “We are thrilled to announce the successful close of our oversubscribed series A round, which will allow us to advance our mission of pioneering a new class of treatments for the 15 million Americans who suffer from neuro-visual disorders,” said Scott Xiao, Luminopia’s co-founder and CEO.
Manufacturers of contact lenses may or may not want prescribers to be agnostic as to brand, but the U.S. Federal Trade Commission’s (FTC) contact lens rule requires that prescribers give the prescription to the customer when the eye exam is complete.
Eyenuk Inc. is significantly extending the scope of its artificial intelligence system for the automatic analysis of retinal images, adding the diagnosis of age-related macular degeneration (AMD) and glaucoma to the EU approved uses of Eyeart AI.