It's not known how age-related macular degeneration (AMD) converts from the dry, relatively benign form to the wet, sight-threatening form, or in which patients that progression is inevitable. It is known, however, that patients in the early stages face a 1.3 percent risk of developing wet AMD within five years, while people who have advanced to the intermediate stages of dry AMD face an 18% chance of progressing to the sight-threatening advanced dry or wet stages. For this latter group, Acuity Medical hopes to offer a safe, painless, non-invasive vision preserving device therapy for use in the physician's office and home care settings.
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
The Belgium-based group has collected heaps of long-term efficacy and safety data which will help stave off the competition.
The Phase III trial of the SERD has shown a significant benefit in the intent-to-treat and ESR1-mutated populations in post-CDK ER+/HER2- metastatic breast cancer but whether the data will be enough to support an equally broad approval remains to be seen.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
