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Research: Healthcare
EyeGate recently delivered positive top-line data in a 20-patient trial studying the firm’s lead product, Ocular Bandage Gel (OBG), in patients with moderate dry eye disease (DED). Compared to the positive control, Allergan’s Refresh Preservative-Free OTC lubricant, OBG eye drops showed improvements in central corneal region staining, high order ocular aberrations (HOA) and best corrected visual acuity (BCVA). These results are indicative of therapeutic benefits and EyeGate is gearing to potentially launch a pivotal trial programme in H220.
EyeGate Pharmaceuticals |
OBG shows benefits in pilot dry eye study
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Pharma & biotech |
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16 April 2020 |
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EyeGate recently delivered positive top-line data in a 20-patient trial studying the firm’s lead product, Ocular Bandage Gel (OBG), in patients with moderate dry eye disease (DED). Compared to the positive control, Allergan’s Refresh Preservative-Free OTC lubricant, OBG eye drops showed improvements in central corneal region staining, high order ocular aberrations (HOA) and best corrected visual acuity (BCVA). These results are indicative of therapeutic benefits and EyeGate is gearing to potentially launch a pivotal trial programme in H220.
Improvements shown in ocular surface measures
EyeGate’s OBG is a topical eye drop based on its proprietary, crosslinked thiolated carboxymethyl-hyaluronic acid (CMHA-S). OBG is intended to create a thin, durable and protective coating to a damaged or disrupted ocular surface, and the crosslinking may resist degradation. In the 14-day pilot study, OBG demonstrated a 25% improvement in corneal staining vs 15% for control, and a 10% improvement at day 7 (vs no improvement with control). For BCVA and HOA, OBG demonstrated trends of improvement over the two-week period, whereas the control did not. EyeGate plans to meet with the FDA in coming months to go over the design of a pivotal study in DED. Since OBG is classified as a device rather than a drug, the company may only require one DED pivotal trial to obtain approval and, depending on FDA guidance, it is possible that it may not require lengthy duration of therapy to achieve the endpoints needed for approval.
DED is a significant market opportunity
DED is one of the largest therapeutic areas in eyecare, as it is estimated to affect over 16 million US adults, and the market size in North America alone was recently estimated at $2.4bn. Currently only two topical eye medications have been FDA-approved to treat DED, lifitegrast (Xiidra by Novartis) and cyclosporine (Restasis by Allergan). While both are effective at treating the inflammatory factors that contribute to DED, OBG can potentially fill a need for a more durable and stable lubricant formulation that supports corneal health and re-epithelialization, as has been shown in the recent pivotal study on post-operative PRK patients.
Valuation: EV of $19m; funded through Q420
EyeGate ended 2019 with $3.78m cash and since raised $4.5m (net) in equity. Its 2019 operating burn rate was $8.16m, but H120 burn should decrease given the completion of the OBG studies. The company estimates that cash on hand should be sufficient through Q420, but we expect the funding needs could increase if a pivotal study in DED is started by YE20, although the current COVID-19 pandemic may affect timing for study commencement.
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Research: Healthcare
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