Outlook Therapeutics' (OTLK) shares were down more than 8% in Thursday trading after the company said it completed its analysis of the 12-week safety and efficacy results for its trial evaluating ONS-5010 in wet age-related macular degeneration.
The trial showed that ONS-5010 demonstrated noninferiority to ranibizumab at week 12, with ONS-5010 achieving a mean improvement of 5.5 letters in best corrected visual acuity, or BCVA, while ranibizumab showed a 6.5-letter improvement, the company said, adding that ONS-5010 was generally well-tolerated, with ocular adverse event rates similar to those of ranibizumab.
The company said it intends to resubmit its biologics license application in Q1, with ONS-5010 already authorized for marketing in the European Union and the UK, and a European launch expected in the first half of 2025.
Outlook also said it entered into warrant inducement transactions expected to generate up to $20.4 million in gross proceeds to fund clinical development programs, its European commercial launch of Lytenava, and working capital.
Price: 2.11, Change: -0.19, Percent Change: -8.26
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