Product & Regulatory Milestones - ONS-5010/LYTENAVA is the first and only approved ophthalmic formulation of Bevacizumab for wet AMD in the EU and UK[5] - The US FDA has accepted the resubmission of the BLA for ONS-5010 with a PDUFA goal date of August 27, 2025[28, 39] - The company received 10 years of market exclusivity in Europe covering 31 countries[6, 39] - LYTENAVA has a list price of £470 (approximately $618) in the UK[12] and €751.61 (approximately $857) in Germany[14] Market Opportunity & Commercialization - The total European anti-VEGF retina market is valued at $3.6 billion[9] - The total US anti-VEGF retina market is valued at $8.5 billion[29] - In Europe, 2.8 million injections of repackaged off-label bevacizumab are administered annually[8] - In the UK, the estimated market share of off-label repackaged bevacizumab is 5%, with 1.3 million anti-VEGF units per annum[12] - In Germany, the estimated market share of off-label repackaged bevacizumab is 50%, with 1.7 million anti-VEGF units per annum[15, 14] - The company projects potential for gross peak sales of over $600 million[16] Financial Status - As of March 31, 2025, the company had $7.6 million in cash[36] - The company's cash position does not include proceeds from a $13 million public offering that closed on May 27, 2025[37]