Regulatory Roundup FINAL

September 20, 2023 - Regulatory Roundup

Updated every Wednesday

Ocugen provided an update on its Phase I/II trial for OCU400, a therapy for retinitis pigmentosa (RP) and Leber congenital amaurosis. Relaying results that include additional subjects, the data show 83% of OCU400-treated subjects demonstrated stabilization or improvements in best corrected visual acuity and 42% of the OCU400-treated patients experienced four-letter improvement, among other findings.

The FDA granted 510 (k) clearance for an AI-powered ophthalmic image management system from Altris AI. Called Altris IMS, the platform is designed to store, organize, and support in-depth analysis of Optical Coherence Tomography (OCT) scans. Altris AI Chief Medical Officer Maria Znamenska, MD, PhD, said in a statement that the platform helps physicians “detect retinal pathologies, pathological signs, and biomarkers. It means less human errors, early detection of the pathologies that can lead to blindness, and better patient outcomes as a result.”

Astellas Pharma, the new parent company of Iveric Bio, announced favorable 24-month topline results from its Phase III GATHER2 clinical trial. The trial evaluated the efficacy and safety of Izervay (avacincaptad pegol intravitreal solution), recently approved for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Results indicated slowed GA growth at 24 months and safety consistent with 12-month data.

Results from Santen’s MERCURY-3 trial support the addition of Roclanda as an alternative fixed-dose combination (FDC) treatment option for patients with primary open-angle glaucoma (POAG) or ocular hypertension. The trial compared Roclanda – an FDC of latanoprost 50 mcg/mL and netarsudil 200 mcg/mL ophthalmic solution – with FDC of bimatoprost 300 mcg and timolol maleate 500 mcg/mL. The results showed comparable intraocular pressure (IOP) lowering and sustained IOP reduction with no serious adverse events.

Tarsier Pharma announced findings from its Phase III trial on TRS01 (eye drop formulation of dazdotuftide). A post-hoc analysis that evaluated the total impact of the drug vs steroids suggests a benefit-risk advantage in noninfectious uveitis; specifically, in uveitic glaucoma. Inflammation parameters were comparable to steroids. While the trial did not meet its primary endpoint, Tarsier plans to meet with the FDA to determine the best path forward, according to a statement.

Myra Vision has launched a first-in-human study of its Calibreye System, a glaucoma drainage device with titratable outflow control designed for moderate to severe glaucoma patients.

Clinical Observations FINAL

September 21, 2023 - Clinical Observations

Updated every Thursday

NovaBay Pharmaceuticals has launched Avenova Allograft in the United States. The prescription product is the only optic allograft manufactured using proprietary processes from BioStem Technologies. It’s intended for use as a protective covering during ocular surface repair. [Learn More About Avenova]

Visual impairment and dementia go hand in hand. Dementia affects parts of the brain that process visual information; at the same time, people with both dementia and poor vision may have an even tougher time recognizing people they know.

A UK-based study found the prevalence of visual impairment is significantly higher in people with dementia, and higher still among those in assisted living and similar communities. Over half of these issues were correctable with either glasses or cataract surgery. The findings suggest a need for a specialized eye care pathway for people with dementia and perhaps specialized optometrists. [Read the Study]


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Heather Johnson

Heather Johnson

Contributing Editor


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