After Outlook Therapeutics Inc. took receipt of another complete response letter (CRL), Wall Street focused on the odds that the U.S. FDA will demand a new study with ONS-5010, or Lytenava (bevacizumab-vikg) against wet age-related macular degeneration (AMD).
Showing similar results as the first phase III trial completed in 2022, Nicox SA’s nitric oxide-donating bimatoprost eye drop, NCX-470, met the primary endpoint in the phase III Denali trial for open-angle glaucoma or ocular hypertension, clearing the way for regulatory filings in both the U.S. and China.
After announcing in April that it would discontinue development of its lead candidate, sozinibercept (OPT-302), in wet age-related macular degeneration (AMD), Opthea Ltd. has come to a settlement agreement that will allow it to avoid bankruptcy and continue operations.
Remegen Co. Ltd. is out-licensing its VEGF/FGF dual-target fusion protein drug, RC28-E, to Santen Pharmaceutical (China) Co. Ltd. in a carve-out deal worth more than ¥1.3 billion (US$180 million).
Aussie gene therapy company Mirugen Pty Ltd. has emerged from stealth mode from the Center for Eye Research Australia in Melbourne, toting a AU$4.5 million (US$2.9 million) seed round that will see it optimize its lead candidate to treat retinitis pigmentosa.
With the U.S. FDA’s approval of Lenz Therapeutics Inc.’s Vizz (aceclidine ophthalmic solution), there is a third eye drop on the market for treating presbyopia. Vizz, however, is the first aceclidine-based eye drop for adults.
Torrent Pharmaceutical Ltd. will buy J. B. Chemicals and Pharmaceuticals Ltd. (JB Pharma) from private equity firm KKR & Co. Inc. at an equity valuation of ₹256.89 billion (US$3 billion), which will then merge into one entity under Torrent Pharma.
Three months after dosing the first patient with its dual vector gene therapy, Splicebio SL has closed a $135 million series B to fund the phase I/II trial of SB-007 in the treatment of Stargardt’s disease to completion. Other adeno-associated viru gene therapies for the inherited retinal disorder have entered the clinic, but SB-007 is the first with the capacity to deliver a full version of the ABCA4 gene that underlies Stargardt’s.
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in phase II, showing a gain of 10 or more letters in visual acuity from baseline at one year in Chinese patients with neovascular age-related macular degeneration.
Aldeyra Therapeutics Inc. is making another run at U.S. FDA clearance for reproxalap in dry eye disease (DED) after nailing the primary endpoint in a phase III randomized, double-masked, vehicle-controlled dry eye chamber trial of 0.25% ophthalmic solution.
RSS
-and-Raymond-Wong-(R).webp?height=488&t=1755204408&width=650 "Mirugen co-founders Keith Martin (L) and Raymond Wong (R)")
