Aldeyra’s sights set on November PDUFA; Synbio startup scores cash

07 Feb 2023
endpts.com
Phase 3NDA
Aldeyra Therapeutics has a date at the FDA, specifically Nov. 23 for its dry eye disease drug. After boldly claiming “ approvability has been put to bed ” last summer with a crossover study win, Aldeyra said Tuesday morning the US agency accepted its drug, reproxalap , for review. Reproxalap failed a Phase III trial in late-2021, but the drug’s maker followed up with another late-stage study testing a new primary endpoint and succeeded last June. A month later, the drug cleared a crossover study, in which it met the primary endpoints tested in both of the previous Phase III trials. FDA’s outside expert panel will not convene to discuss the drug, as of current plans, Aldeyra said. CEO and president Todd Brady said an approval could mean a “rapid and durable” new treatment option for patients “dissatisfied with currently available therapies.” The small biotech is going up against Novartis’ Xiidra and AbbVie/Allergan’s Restasis. A Phase III is also testing the drug in allergic conjunctivitis , with two late-stage win s already under Aldeyra’s belt in that indication. The company submitted the NDA last November, and Aldeyra submitted the approval request paperwork for another drug, ADX-2191 , for primary vitreoretinal lymphoma a month later. Cambridge, England, company Evonetix reeled in another $24 million for its Series B , bringing the round to more than $54 million. The proceeds will help Evonetix build out its semiconductor chips and its technology for gene-length DNA for research across a variety of fields: biopharma, food, agriculture and data storage. “Evonetix is in a very exciting phase, having recently opened our early access program. This investment will support us as we execute on our commercial strategy to put benchtop gene synthesis in the hands of users,” CEO Colin McCracken said in a statement. Financial backers include Foresite Capital, Molten Ventures, Morningside, DCVC, Cambridge Consultants, Civilization Ventures and Providence.
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