Outlook Therapeutics' Vision Loss Drug Matches Novartis' Drug in Efficacy

Outlook Therapeutics' ONS-5010, an ophthalmic formulation of bevacizumab, has shown promising results in clinical trials, matching the efficacy of Novartis' Lucentis (ranibizumab) in treating wet age-related macular degeneration (AMD). The NORSE TWO pivotal trial demonstrated that ONS-5010 is non-inferior to Lucentis in terms of visual acuity improvement and durability of effect.



In the NORSE TWO trial, ONS-5010 showed a mean change in best-corrected visual acuity (BCVA) from baseline of 11.2 letters gained at 12 weeks, compared to 5.8 letters gained in the ranibizumab arm (p = 0.0043). Additionally, 41% of patients in the ONS-5010 group gained at least 15 letters, compared to 23% in the ranibizumab group (p = 0.0052). These results indicate that ONS-5010 is non-inferior to Lucentis in terms of visual acuity improvement and durability of effect.

The potential cost savings and accessibility benefits of ONS-5010 compared to Lucentis are significant. Off-label bevacizumab (Avastin) is significantly cheaper than approved biologics like ranibizumab and aflibercept, with one dose ranging from $50 to $150 compared to around $2000 per injection for approved biologics. If approved, ONS-5010 would provide an FDA-approved option for physicians, potentially reducing the financial burden on patients and healthcare systems.

Moreover, the repackaging process at compounding pharmacies for off-label bevacizumab raises concerns about impurities, sterility, and dosage consistency. ONS-5010, if approved, would be available in a single-use vial, addressing these concerns and providing a more accessible and reliable treatment option for patients with wet AMD.

The FDA's decision on ONS-5010's Biologics License Application (BLA) will significantly impact Outlook Therapeutics' financial outlook and market position. If approved, ONS-5010 would be the first and only FDA-approved ophthalmic formulation of bevacizumab for treating wet AMD, providing the company with a significant competitive advantage. This approval would likely lead to increased revenue and market share, as clinicians would have an FDA-approved alternative to the off-label repackaged bevacizumab currently used.

However, if the FDA does not approve ONS-5010, the company's financial outlook could be negatively affected. The company has invested significant resources into the development and clinical trials of ONS-5010, and a rejection of the BLA could result in additional costs and delays in bringing the product to market. Furthermore, the company's market position could be weakened if competitors introduce similar products or if the off-label use of bevacizumab remains prevalent.

In conclusion, Outlook Therapeutics' ONS-5010 has shown promising results in clinical trials, matching the efficacy of Novartis' Lucentis in treating wet AMD. The potential cost savings and accessibility benefits of ONS-5010 compared to Lucentis are significant, and the FDA's decision on ONS-5010's BLA will have a substantial impact on the company's financial outlook and market position.