Notal Vision Inc. released two clinical reports it said prove the feasibility and efficacy of its patient-operated, home-based optical coherence tomography (OCT) device for monitoring wet age-related macular degeneration (AMD). This comes in the wake of a 2021 report that concluded patient operation of the Notal Vision Home OCT (NVHO) and its machine learning algorithm were generally on par with human experts evaluating retinal fluid and fluid volume in patients with AMD.
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.
Aldeyra Therapeutics Inc. CEO Todd Brady said that, with new data from a crossover trial with reproxalap in dry eye disease (DED), the question of “approvability has been put to bed,” and the company plans a pre-NDA meeting with U.S. FDA in the third quarter of this year.
Samsara Vision Inc. signed a deal with China’s Lansheng Medical Corp. (Myvision) to bring Samsara’s next-generation visual prosthetic devices to mainland China, Macau, the Hanain Province, and Hong Kong.
Kriya Therapeutics Inc. has raised a $270 million series C financing to further develop its pipeline of gene therapies for treating cancer, ophthalmological problems, and rare and chronic diseases. The Redwood City, Calif.-based company has greatly expanded its employee roster, from about seven people to around 160 people, since its $80 million series A in May 2020 and scaled its learning-enabled tech and cloud computing abilities. It also further solidified its technology, manufacturing, R&D, and therapeutics units, something it plans to continue with the series C money.
Samsara Vision Inc. has received FDA approval to begin a U.S.-based PMA supplement trial to assess improvements in visual acuity and safety of its smaller-incision next-generation implantable miniature telescope, called SING IMT, in people with late-stage age-related macular degeneration (AMD). The device has been available in the EU since 2020.
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.
Shares in Gensight Biologics SA dropped by as much as 41% April 7 on news that the Paris-based gene therapy firm failed to complete a second manufacturing campaign within five months, a setback that could delay a commercial launch of its lead product, Lumevoq, by at least a year.
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.
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.
