SYLENTIS

Sylentis, a subsidiary of PharmaMar, is a biotechnology company focused on developing novel medications using RNA interference gene silencing technology. The company's primary focus is on ophthalmology, with products in development for conditions such as glaucoma, ocular allergies, dry eye syndrome, and age-related macular degeneration (AMD). Sylentis utilizes its proprietary SirFinder artificial intelligence system, which employs neural network-based algorithms, support vector machine, and machine learning to analyze data and rationally design small interfering RNAs (siRNAs).

One of Sylentis' key products in development is tivanisiran, an siRNA therapy designed to inhibit the synthesis of Transient Receptor Potential Vanilloid-1 (TRPV1) for the treatment of dry eye disease. In December 2023, the company announced that its phase 3 FYDES trial of tivanisiran met its primary endpoint by demonstrating long-term safety in patients with dry eye disease. However, a separate phase 3 trial of tivanisiran failed to meet its primary endpoint of improving dry eye symptoms associated with Sjögren's Syndrome.

Another significant product in Sylentis' pipeline is SYL1801, an siRNA therapy being investigated for the treatment of wet age-related macular degeneration. SYL1801 is designed to transcriptionally down-regulate Nrarp expression, targeting a different vascularization factor than VEGF. As of November 2022, a phase 2 trial of SYL1801 was ongoing, evaluating its effect on visual acuity when administered as a daily eye drop.

In April 2022, Sylentis inaugurated Spain's first and Europe's third GMP-compliant plant for manufacturing oligonucleotides in the Madrid Technology Park in Tres Cantos. This facility is operational and capable of producing tivanisiran and SYL1801, as well as offering manufacturing and analysis services to other pharmaceutical companies requiring oligonucleotide production.