Ann: Becoming a substantial holder, page-42

For those who wish to understand reality:


Opthea faces several challenges in the competitive wet AMD market, despite its promising drug development efforts. These include:

1. Intense Competition

• The wet AMD market is highly competitive, dominated by established players like Regeneron (Eylea), Roche (Vabysmo), and Novartis (Beovu). These companies have significant resources and market presence, making it challenging for new entrants like Opthea to gain traction

• Emerging competitors, such as Ocular Therapeutix, are also developing novel therapies, adding pressure on Opthea to differentiate its drug
  

2. Biosimilar Threats

• Patent expirations for leading drugs like Eylea and Lucentis are expected to lead to the introduction of biosimilars, which are typically priced lower. This could create pricing pressure and reduce the market share available for Opthea's therapy
  

3. Regulatory Challenges

• The biotechnology sector faces stringent regulatory hurdles, with high rejection rates for first-time submissions (e.g., FDA: 68%, EMA: 55%). Additional clinical trial requirements or delays could slow down the approval and commercialization of Opthea’s OPT-302

4. Clinical Trial Risks

• Clinical trial failure rates in ophthalmology are significant, especially at Phase III (40–50%). Any setbacks in Opthea's ongoing Phase III trials could jeopardize its timeline for approval and market entry

5. Investor Sentiment and Funding Volatility

• Biotech companies often experience fluctuating investor sentiment and funding challenges, which can impact their ability to sustain operations during lengthy development cycles

6. Market Dynamics

• The wet AMD market is evolving with new therapies offering improved efficacy, longer treatment intervals, or novel mechanisms of action. Opthea must demonstrate clear advantages over both existing treatments and emerging options to secure a competitive edge