Our clients’ affinity for us continues to grow. Aagami has received another contract extension. The client is developing small molecule eye drops as First-in-Class, Non-Invasive Treatment of Pre-Surgical Age-Related Cataract.
Highlights of Livionex small molecule eye drops
- Daily dosing of an eye drop, which has shown clinically significant improvements in visual function (contrast sensitivity and low-contrast visual acuity)
- Modulates Iron (Fe) & Calcium (Ca) in therapeutic targets
- Down-Regulating Multiple Inflammatory Mediators, Targeting the Apex of Inflammation and Cell Death Processes
- Multiple Mechanisms of Action
- Established Proof of Concept to Improve Visual Function while Reducing Lens Opacity by breaking up Light Scattering Aggregates.
- Active ingredient is topically delivered at therapeutic levels to the eye. Breakthrough PK Study Results (Intraocular Drug Delivery to the aqueous, lens and retina)
- Excellent Safety Profile without Serious AEs
- Data published on Journal of American Ophthalmology and presented to FDA as part of an End-of-Phase 2 Meeting
- Phase 3 initiation approved by US FDA.
- Robust and Broad worldwide patent protection until 2044
- Research collaborations include NIH, DoD & Harvard and other leading US Universities.
Market Approval timeline in the US with Sales projection
- Phase 3A (1H2026 – 2H2027) [estimated cost $50 M]
- Phase 3B (1H2027 – 2H2028) [estimated cost $50 M]
- NDA & Approval (2H2029)
- $960 M Estimated US Sales at 10% penetration
The client is seeking to out-license their Eye drop asset for various regions, and also open to strategic investments which will help in funding the Phase 3 trials and take the product across the finish line.
If you would like to know more, please contact us on action@aagami.com.