Bausch boosted ahead of eye spin-off

NOV03 posts a pivotal win but the late-stage dry eye pipeline is crowded.

Despite various products being marketed for dry eye disease, there is still an unmet need in the disorder. This explains why the late-stage pipeline is relatively crowded, with many different mechanisms being tested.

One of these projects, Bausch Health Companies' NOV03, yesterday succeeded in its first phase 3 trial, Gobi. The project will have to repeat the trick in its second pivotal study, Mojave, but if it does NOV03 could become a key product for the new-look Bausch & Lomb, which is set to spin off from its parent company.

Still, getting products approved for dry eye disease has not always been easy – just ask Kala, which finally got the go-ahead for Eysuvis last year after having to carry out three pivotal trials. One of Eysuvis’s initial studies had shown a benefit on signs but not symptoms of dry eye disease, which spurred the FDA to ask for data from a third trial (Persistence pays off for Kala, March 10, 2020).

Signs and symptoms

In a positive sign for NOV03, Gobi hit on both signs and symptoms. On signs, there was a statistically significant reduction in total corneal fluorescein staining, a measure of eye damage, with NOV03 versus saline at 57 days. On symptoms, there was a statistically significant decrease in the dryness score with NOV03 versus saline at 57 days. Bausch said the p values for both co-primary endpoints were less than 0.001, but did not disclose the numerical reductions.

On the face of it the win looks impressive. But Evercore ISI’s Umer Raffat noted that an oil-based eye drop would have been a more stringent comparator, though he added that Bausch had presumably been guided by the FDA on the comparator to use.

He also questioned whether the project could ultimately compete with approved dry eye drugs like Abbvie’s Restasis and Novartis’s Xiidra – unlike studies of these products, the Gobi trial did not allow the use of artificial tears, a mainstay of dry eye therapy.

Finally, NOV03 is given four times per day, which could cause problems with compliance.

Stifel analysts were more optimistic about NOV03’s chances, saying the data, along with the project's novel mechanism, “position it perfectly” in the dry eye disease landscape. The semiflourinated alkane is designed to improve the function of the meibomian glands in the eye; these are responsible for secreting an oil that helps keep the eyes moist, and Bausch says their dysfunction is the cause of most cases of dry eye disease.

NOV03 is already marketed in Europe as Evotears by its originator, Novaliq. Bausch licensed the asset in the US and Canada in 2019.

Room for improvement

There is room for improvement in the treatment of dry eye disease. Stifel noted that the likes of Restasis and Xiidra do not provide patients with full relief and that, “due to the inadequacies of current therapies”, only two million of the 16 million US dry eye disease patients are receiving treatment.

Despite its shortcomings Xiidra is still forecast to make $688m in 2026, according to Evaluate Pharma, and tempted Novartis to shell out $3.4bn, so perhaps it is no wonder that many groups are still trying to crack dry eye disease.

One of the more interesting is Oyster Point, which has reformulated smoking-cessation drug Chantix as a nasal spray known as OC-01. The company is expecting an approval decision in October after posting positive pivotal data last year; only one of the doses tested improved symptoms of dry eye (Remember Chantix? It’s back – for dry eye disease, May 11, 2020).

Only one pipeline project, Aldeyra’s reproxalap, currently has sellside forecasts attached – Evaluate Pharma consensus puts 2026 dry eye sales at $391m. The Tranquility and Tranquility-2 phase 3 trials, evaluating signs of dry eye disease, are due to read out in the second half.

Ultimately, several different mechanisms might be needed to address this underserved market, Stifel reckons. To get a piece of it, all Bausch now needs to do is replicate the Gobi results in Mojave.

Selected novel agents in late-stage development for dry eye disease
Project Company Description Note
OC-01 Oyster Point Pharma Nicotinic acetylcholine receptor agonist, nasal spray Reformulation of Chantix; Pdufa date on October 17, 2021
Phase 3
SkQ1  Essex Bio-Technology/Mitotech  Mitochondria-targeted antioxidant Ph3 Vista-2 study hit in Feb 2021, Vista-3 study planned
Nov-03 Bausch Health Companies/Novaliq  Lipid regulator  Ph3 Gobi study hit Apr 2021, Mojave study completes Sep 2021
Reproxalap ophthalmic solution Aldeyra Therapeutics Aldehyde inhibitor Ph3 Tranquility & Tranquility-2 planned to start H1, both studies to read out H2 2021
Tivanisiran Pharmamar RNAi eye drop inhibiting TRPV-1 Ph3 SYL1001 _V study in dry eye with Sjögren 's Syndrome began Mar 2021
Tavilermide Mimetogen Pharmaceuticals Nerve growth factor mimetic Ph3 MIM-728 study completed enrolment in Mar 2020, results had been due in Q4 2020
RGN-259 Regenerx Biopharmaceuticals/GtreeBNT Thymosin β-4 receptor agonist Ph3 Arise-3 study failed in Mar 2021 but companies plan to meet FDA
HL036 Daewoong Pharmaceutical/Hanall Biopharma TNFa inhibitor Ph3 Velos-2 study failed in Jan 2020 but showed some benefits; second ph3 completes Feb 2022
Source: Evaluate Pharma,

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