Ocular Therapeutix, a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced topline Phase 1 clinical trial results of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease (DED).
“The results of the Phase 1 clinical trial provide an early look at the safety, tolerability, durability, and potential biological activity of OTX-CSI,” said Michael Goldstein, MD, MBA, Chief Medical Officer. “While the study enrolled a small number of subjects and was open-label, the results seen thus far are very encouraging.
Our novel intracanalicular insert delivered a consistent dose of cyclosporine without preservatives over approximately 12 weeks, in a manner we believe to be both less irritating to the ocular surface and also faster acting than current standard of care eye drop therapies. We believe that if approved by the FDA, OTX-CSI has the potential to become a highly differentiated treatment that would provide significant benefit to patients with dry eye disease and allow them a hands-free alternative to current therapies.”
The Phase 1, U.S.-based, open label, single-center clinical trial was intended to evaluate safety, tolerability, durability, and biological activity of OTX-CSI by measuring signs and symptoms of DED in five subjects (10 eyes) over approximately 16 weeks (a 12-week study period, with an additional 4-week safety follow-up).
In the clinical trial, OTX-CSI was administered by a physician as a bioresorbable intracanalicular insert to both eyes in five subjects with DED. All subjects completed the 16-week study period with no drop-outs. No serious adverse effects were reported. The inserts were observed to be well-tolerated, and there were no adverse events of stinging, irritation, blurred vision or tearing reported or observed.
Tear production as measured by the Schirmer’s test improved from mean values of 4.2 mm at baseline to 8.2 mm at Week 12. One of five (20%) subjects had a ≥ 10mm increase in Schirmer’s score at Week 12 from baseline. Subjects treated with OTX-CSI demonstrated an improvement in signs of DED as measured by corneal total fluorescein staining (a mean value of 6.7 at baseline, improved to a mean value of 2.7 at Week 12, on a scale of 0 to 15) and an improvement in symptoms of DED as measured by the visual analog scale (VAS) eye dryness severity score (a mean value of 51 at baseline, improved to a mean value of 33 at Week 12, on a scale of 0 to 100) and the VAS dry eye frequency score (a mean value of 51 at baseline, improved to a mean value of 31 at Week 12, on a scale of 0 to 100).
The onset of action of OTX-CSI was seen as early as two weeks for both signs and symptoms of DED and continued over the 16 week study period.
The Company recently announced that the first patient was dosed in a Phase 2, U.S.-based, randomized, masked, vehicle controlled, multi-center clinical trial evaluating two different formulations of OTX-CSI with vehicle insert in approximately 105 subjects who will be followed for a period of 16 weeks.
Dry eye disease is a common, multifactorial disease of the tears and ocular surface that results in symptoms of discomfort (such as burning sensation, itching, redness, stinging, pain and foreign body sensation), visual disturbance, and tear film instability that can cause potential damage to the ocular surface.
Inflammation of the lacrimal gland and ocular surface have been shown to play a key role in dry eye disease, resulting in a reduction in tear production. Dry eye disease is one of the most common ophthalmic disorders presenting to clinicians and the Market Scope 2019 Dry Eye Products Market Report estimated that more than 17.2 million adults in the United States have been diagnosed with the disorder, including an estimated 8.6 million classified as having a moderate to severe form of the disease.
Source: Company Press Release