• IVERIC bio announced the FDA granted Breakthrough Therapy designation for avacincaptad pegol (ACP, also known as Zimura), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy secondary to AMD. To date, ACP is the first investigational therapy to receive Breakthrough Therapy designation status for this indication, which was granted based on the 12-month pre-specified primary endpoint data in the GATHER1 and GATHER2 pivotal clinical trials. Recently, Iveric bio announced the submission of the first part of its new drug application (NDA) for rolling review, which included the full clinical data package from the GATHER1 and GATHER2 pivotal trials. The company is on track to complete the final part of the NDA submission by the end of this year.

• AEYE Health received 510(k) clearance from the FDA to market its diagnostic screening system, the AEYE-DS, for diabetic retinopathy. AEYE's FDA approval is based on pivotal Phase 3 study results which showed both efficacy and usability of autonomous screening diagnostics in ophthalmology, which include: Clinical efficacy with 93% sensitivity and 91.4% specificity; recognition as the first solution that requires only a single image per eye, which shortens the screening process to one minute; and best-in-class imageability, delivering a diagnostic result for more than 99% of patients and rarely requiring dilation. The AEYE-DS is indicated for use with images obtained by the Topcon NW-400 desktop retinal camera.

• SVision Imaging, a company that develops advanced ophthalmic technologies, has rebranded to Intalight. The rebranding highlights the company’s mission and growth strategy to develop advanced ophthalmic technologies to target unmet needs across OCT imaging and its commitment to introducing this technology in the United States. Intalight is also in the process of submitting a 510(k) for its Swept Source platform, DREAM OCT. The structure of the DREAM OCT Swept-Source 12 mm super-depth scanning allows sharp imaging of the choroid and retina and a large portion of the vitreous space. 

• Nidek launched the NT-1p Non-Contact Tono/Pachymeter, a device that fully automates reliable non-contact tonometry and pachymetry. By placing the chin on the chinrest, the NT-1p automatically detects the position of the eyes and begins measurement without pressing any buttons. Voice guidance (available in nine languages) facilitates smooth measurement for any operator. An air-nozzle contact sensor ensures safety while performing fully automatic measurements. The continuous range of tilt and swivel of the screen allows the NT-1p to be placed anywhere in an examination room, including installation against a wall or in a corner. Models are available with or without a joystick, and the addition of a hand-held control and tablet control software allow for remote operation.

• Azura Ophthalmics Ltd., a clinical-stage biopharmaceutical company developing a new therapeutic class of ophthalmic keratolytics for ocular surface diseases, announced positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in meibomian gland dysfunction. The trial met its co-primary endpoints of significant improvements in Meibomian Glands Yielding Liquid Secretion score, with patients experiencing an average increase of 1.8 more open glands secreting meibum from baseline (p = 0.0004); and significant improvements in Ocular Surface Disease Index (OSDI) score, with patients reporting an average improvement of 3.5 from baseline (p = 0.0438). The trial also met its secondary endpoints.

• According to a National Institute on Aging (NIA)-funded study published in JAMA Neurology, up to 100,000 US dementia cases could have potentially been prevented with improved eye care. The Lancet Commission on Dementia Prevention, Intervention, and Care had previously expanded its list of other modifiable risk factors for dementia. This newer research featured data from the NIA-funded University of Michigan Health and Retirement Study. The scientists found that one of the top preventive actions that may reduce risk for Alzheimer’s and related dementias is getting vision problems corrected through methods such as eye exams, eyeglasses and cataract surgery. Investigators noted that about 1.8% of US dementia cases were associated with visual impairment, and projected that by 2050, that total would rise to around 250,000 cases.

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.