Oyster Point announced that top-line results from its Phase III Onset-2 trial evaluating OC-01 for dry eye disease (DES) in early May. The results demonstrated a statistically significant improvement in patients gaining ≥10mm in Schirmer’s score at Week 4 versus control. The positive results from this late-stage clinical trial could trigger a wave of hope for those affected and those caring for patients with dry eye syndrome (DES), says GlobalData, a leading data and analytics company.

Vinie Varkey, Senior analyst, Neurology & Ophthalmology at GlobalData comments: “Current treatment options for DES in the US are mainly dominated by a mix of prescription, off-label, and over-the-counter (OTC) products. Since Restasis’ first-to-market launch in the US in 2003, Novartis’ Xiidra’s (lifitegrast ophthalmic solution) launch in the US in 2016, and Cequa’s launch in 2019, there have been no other approved therapies for DES in this market. Corticosteroids are currently used as off-label options and OTC products are represented by artificial tears.” 

OC-01 is understood to be a highly selective nicotinic acetylcholine receptor agonist, which is a first-in-class approach for DES. When combined with OC-01’s novel ROA, this particular therapy’s potential in DES increases compared to currently available treatment options.

Varkey continues: “The novel ROA associated with OC-01, such as in nasal sprays, may have a positive effect on the patient compliance of this particular therapy compared to currently available marketed therapies – all of which have an ophthalmic ROA (eye-drops). Key opinion leaders (KOLs) interviewed by GlobalData have emphasized this feature as an interesting differentiator, but have also stated that the therapy will need to establish a strong efficacy profile in order for it to witness commercial success.

“Given the low levels of drug approvals historically for this indication, any advancements in the DES field are likely to raise excitement. As Oyster Point Pharma prepares to submit a new drug application in the second half of 2020 for OC-01 for treatment of signs and symptoms of DES, there is an anticipation that this excitement is expected to be shared by DES patients and their physicians should this therapy receive an approval from the US FDA.”