Sensory
4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.
Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.
Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.
Series B cash will be used to advance its Stargardt disease gene therapy.
The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.
Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.
Deal snapshot: With several internal non-opioid pain candidates in Phase II or earlier, Lilly looks to add R&D potential in pain with $1bn buyout of SiteOne.
Roche Pharmaceuticals’ area head, Asia Pacific, outlines how the Swiss group is helping nurture the wider ecosystem and setting itself up for a bigger play in the ophthalmology space by combining scientific expertise with regional insights.
Chief medical officer Eliav Barr discussed Merck’s investment in new therapeutic areas and business development in an interview with Scrip.
Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.
The company said the NORSE EIGHT trial of ONS-5010 did not meet the primary endpoint of showing noninferiority to ranibizumab, but it still plans to file for US FDA approval.
But differences in trial design means it is hard to handicap GSK’s product against Mirum’s volixibat.
The company is developing the drug as a way to reduce injection burden for wet AMD patients and plans to meet with the US FDA early next year to discuss Phase IIb topline results.
The dual agonist of the FP and EP3 receptors has shown efficacy in a Japanese Phase III trial and completed its US Phase II study, which aligns with the Japanese firm’s global expansion strategy for glaucoma products.
New hi-tech labs in Basel are aimed at boosting Roche’s R&D productivity, but despite streamlining in San Francisco, its twin-track drug discovery with Genentech will remain.
Results from the Phase III THRIVE trial in active thyroid eye disease had analysts calling veligrotug “best-in-class” as they anticipate results from THRIVE-2 in chronic TED later this year.
The group has stopped further development of the IL-17A inhibitor in hidradenitis suppurativa and psoriatic arthritis, and intends to pivot to a thyroid eye disease therapy.
Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.
The company said earlier this year that it would resubmit reproxalap for US FDA approval before the end of 2024 once it completed another Phase III trial and is eyeing both acute and chronic use.
Sales of the Swiss group’s bispecific in retinal vein occlusion are forecast to increase out to 2030 as sales of Eylea and Lucentis fall.