The treatment paradigm for dry eye syndrome is set to look brighter as two late-stage pipeline therapies have recently posted significant updates. While the first update was about a corticosteroid therapy, the second is related to therapy with a novel route of administration (ROA) for dry eye syndrome. If approved, either or both of these therapies could raise enthusiasm among patients and physicians within this indication, although the extent of this enthusiasm may be subtle when looking at the broader impact of these treatment options on the treatment paradigm.
On May 4, Kala Pharmaceuticals announced that it had resubmitted new drug application (NDA) for Eysuvis, an ophthalmic solution of 0.25% loteprednol etabonate, for treatment of signs and symptoms of dry eye syndrome. The resubmission was in response to the FDA’s complete response letter to the company issued in August 2019. The basis of the NDA was the results of the Phase III STRIDE 3 trial, where Eysuvis met its primary endpoint of ocular discomfort severity (ODS) at Day 15 in the overall intent-to-treat (ITT) population and in a pre-defined subgroup of ITT patients with more severe ocular discomfort at baseline. The results were also positive on the secondary endpoint of conjunctival hyperemia at Day 15 in the ITT population and ODS at Day 8 in the ITT population.
Oyster Point Pharma’s OC-01 nasal spray for dry eye syndrome also had positive results. On 11 May, the company announced that top-line results from its Phase III Onset-2 trial had demonstrated a statistically significant improvement in patients gaining ≥10mm in Schirmer’s score at Week 4 versus control. The novel ROA associated with OC-01 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.
Current treatment options for dry eye syndrome in the US are mainly dominated by a mix of prescription, off-label, and over-the-counter (OTC) products. Since Restasis’ (cyclosporine ophthalmic emulsion) first-to-market launch in the US in 2003, Novartis’ Xiidra’s (lifitegrast ophthalmic solution) launch in the US in 2016, and Cequa’s (cyclosporine ophthalmic solution) launch in 2019, there have been no other approved therapies for dry eye syndrome in this market. Additionally, corticosteroids are currently used as off-label options for the condition. Therefore, any advancements in the dry eye syndrome field are likely to raise excitement given the low levels of drug approvals historically for this indication.
OC-01 is understood to be a highly selective nicotinic acetylcholine receptor agonist, which is a first-in-class approach for dry eye syndrome. When combined with OC-01’s novel ROA, this particular therapy’s potential in the condition increases compared to currently available treatment options. However, Eysuvis’ mechanism of action is similar to that of other off-label corticosteroid therapies that are currently being used for the treatment of DES. The general consensus among KOLs interviewed by GlobalData was that a corticosteroid therapy would be prescribed with caution. If Eysuvis does receive an FDA nod, it is likely that this will raise confidence among physicians when it comes to prescribing this particular corticosteroid therapy.
It still remains to be seen how a branded corticosteroid therapy will play out in the dry eye syndrome market in the US when compared to off-label options, which are likely to be priced at a lower price point. Nonetheless, the aforementioned advancements of late-stage pipeline therapies are cause for anticipation for dry eye syndrome patients and their physicians.