The U.S. FDA inked a Dec. 20, 2022, warning letter to Righteye LLC that handed the company a list of quality system issues in dire need of redress, but the agency was more concerned about off-label promotion of the Righteye vision system as a method for evaluating the patient’s ocular tremors as a sign of Parkinson’s disease.
“If you can see the future, you can change it. People say your eyes are the window to your soul, but the eyes are actually the window to your future health,” Toku Eyes Ltd. Founder and CEO Ehsan Vaghefi told BioWorld.
Tears shed today by patients frustrated by an inability to obtain a diagnosis could speed diagnoses for others in the future. Researchers at Wenzhou Medical University, China, have developed a new nano membrane system, dubbed I-Tears, that harvests and purifies tiny droplets called exosomes from tears, allowing rapid analysis for disease biomarkers.
Ophthalmic and microsurgery device maker Carl Zeiss Meditec AG is investing in regenerative medicine startup Precise Bio Ltd. to jointly develop 4D bio-fabricated corneal transplants for diseases that require endothelial keratoplasty and natural lenticule transplants. Under the terms of the agreement, Carl Zeiss Meditec will lead a series B financing round in Precise Bio and fund development of two cornea transplant products.
China’s National Medical Products Administration (NMPA) approved Ocumension Therapeutics Ltd.’s and Eyepoint Pharmaceuticals Inc.’s drug-device combination product, Yutiq (fluocinolone acetonide intravitreal implant), for chronic non-infectious uveitis affecting the posterior segment of the eye.
A technology developed at the University of Birmingham, U.K., has been spun off as a potential treatment for ocular surface diseases. The platform technology from startup Healome Therapeutics Ltd. was developed by a team of material scientists at the University’s Healthcare Technologies Institute (HTI) that translates health technology concepts to products for clinical trials.
Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated.
Lumithera Inc. will acquire Diopsys Inc. for an undisclosed amount in an all-stock transaction expected to close in the next few months. The deal has been approved by shareholders of both companies. Together, they plan to form a theranostic company that can provide a continuum of care for patients with age-related macular degeneration and other degenerative ocular diseases or injury.
Alcon AG plans to acquire Ivantis Inc. for $475 million at closing, regaining a significant position in the lucrative minimally invasive glaucoma surgery (MIGS) space through the addition of the Hydrus microstent device to its ophthalmology portfolio. In addition to the up-front payment, the deal includes additional unspecified contingent payments dependent on achievement of certain milestones. The transaction is expected to close in the first quarter of 2022.