By Brian Marckx, CFA
Earlier this week (Jan 30th) EyeGate (NASDAQ:EYEG) announced encouraging top-line results of its human pilot study of its Ocular Bandage Gel (OBG). While the study was small, results indicate that OBG may be associated with faster corneal healing following eye surgery as compared to standard of care. We view this as meaningfully positive as it sets the stage to move OBG into a larger study – which is now in the planning stage and, assuming IDE approval, could kick off in Q2.
As a reminder, OBG is the lead CMHA-S candidate which came from the Jade Therapeutics acquisition and is being developed for corneal repair indications. Given the strong safety profile of the compound and expected (relatively streamlined) De Novo 510(k) FDA pathway, we think OBG may represent one of EYEG’s most near-term commercialization opportunities.
The pilot study compared OBG to artificial tears with bandage contact lens (BCL) in patients undergoing bilateral photorefractive keratectomy (“PRK”). PRK is a type of vision-correction laser eye surgery - recovery from which includes regrowth of the epithelium (i.e. thin outer layer of the cornea).
Ocular Bandage Gel photoreactive keratectomy pilot study
- Objective: evaluate safety and performance of OBG eye drop administered 4x/day for 14 days with or without a BCL as compared to artificial tears and a BCL
- Primary efficacy endpoint: complete wound closure by Day 3
- Design: prospective, randomized, controlled study in up to 39 subjects undergoing bilateral PRK surgery.
Subjects randomized to one of three cohorts;
- Arm 1 (n=12): EyeGate Ocular Bandage Gel 4x/day for 2 weeks after surgery without a BCL
- Arm 2 (n=14): EyeGate Ocular Bandage Gel 4x/day for 2 weeks after surgery in combination with a BCL
- Arm 3 (n=13): Artificial tears 4x/day and BCL
Topline results of the pilot study, which was the first in-human study of OBG, showed a greater proportion of OBG-treated patients versus those treated with standard of care met the primary endpoint of complete wound closure by Day 3. 9 of the 12 (75%) patients treated with OBG alone (i.e. no BCL) met the primary endpoint, compared to 9 of the 14 (64.3%) OBG+BCL patients and just 7 of the 13 (53.8%) artificial tears+BCL patients.
Remaining wound surface area on Day 1 (24 hours following surgery) was also assessed and similarly favored the OBG-alone cohort which had an average wound size of just 18.5mm. This compares to 40.7mm of the OBG+BCL group and 39.5mm of the artificial tears+BCL cohort.
While specifics were not provided relative to adverse events, EYEG did note in their PR that the study demonstrated safety and tolerability.
Given the positive results of the pilot study, EYEG plans to move into a double-blinded study comparing OBG-alone (OGB monotherapy) to BCL and hopes to commence the study in Q2 of this year (following IDE approval). We look forward to hearing details about the planned design and size of this study and note that given the de-risked nature of OBG, if efficacy is confirmed in this follow-up study, we think the likelihood of eventual commercialization could at that point be reasonably high.
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