Bausch & Lomb option for Mimetogen dry eye drug terminated
This article was originally published in Scrip
Bausch & Lomb, a division of Valeant Pharmaceuticals, apparently did not exercise its option to license the Mimetogen Pharmaceuticals dry eye drug candidate MIM-D3 following recently reported positive Phase III results.
Montreal, Canada-based Mimetogen said on 11 September that the exclusive option agreement announced in July 2013 has been terminated. The deal with Bausch & Lomb gave Mimetogen an undisclosed upfront fee, but the company was not entitled to milestone payments and royalties unless Valeant's ophthalmology business group exercised its option for MIM-D3 based on the top-line Phase III results (scripintelligence.com, 19 July 2013).
Mimetogen's drugs are designed to mimic proteins called neurotrophins, such as nerve growth factor (NGF), which activates the tropomyosin-related kinase (TrkA) receptor. MIM-D3 is a partial TrkA receptor agonist.
Mimetogen's 403-patient Phase III clinical trial assessed MIM-D3 with the ophthalmology clinical research organization Ora's Controlled Adverse Environment (CAE) chamber to measure patients' ability to withstand a stressful drying environment on the eye. Trial participants also kept diaries to track dry eye symptom severity during the study period.
Mimetogen did not report measurements or percentage improvements for the Phase III study's primary endpoints (corneal fluorescein staining and ocular dryness) and secondary endpoints, but the company said patients treated with MIM-D3 had statistically significant improvements versus placebo at eight weeks. Ocular dryness results also were withheld.
Endpoint | P-value (MIM-D3 versus placebo) |
Central corneal fluorescein staining (change from pre to post CAE) measured by the Ora Calibra Scale | P=0.0134 |
Total corneal fluorescein staining (change from pre to post CAE) measured by the Ora Calibra Scale | P=0.05 |
Mean blurred vision improvements (via questionnaire) | P=0.0393 |
Reading improvements (via questionnaire) | P=0.0433 |
Watching TV improvements (via questionnaire) | P=0.0046 |
Mimetogen said its eye drops were comfortable and well-tolerated with no unexpected or serious ocular adverse events. All side effects were mild and transient.
The most common adverse events were reduction of visual acuity for 3% of MIM-D3 and 3% of placebo-treated patients; instillation site pain for 1% and 1.5% of MIM-D3 and placebo patients, respectively; and eye irritation for 1.5% of patients in the placebo group with no irritation reported in the MIM-D3 group.
"MIM-D3, a novel growth factor mimetic, represents a potential first-in-class therapy for the estimated $3bn US market," Mimetogen president and CEO Garth Cumberlidge said when the company announced its Phase III results.
Mimetogen has begun preparation for further clinical and non-clinical studies, but the private company did not indicate how it will fund additional research without a partner.
Sagient Research said in a 9 September BioMedTracker report that the company probably will need to do at least one more Phase III clinical trial to win US FDA approval for MIM-D3 in the treatment of dry eye.
The company will face tough competition if the drug ever reaches the market, since the dry eye field is dominated by at least one blockbuster. Allergan's Restasis (cyclosporine) generated $940m in 2013 sales and is expected to reach $1.04bn to $1.07bn in 2014 sales.
Also, the BioMedTracker database lists five drugs in Phase III development for dry eye disease, including MIM-D3, plus 14 treatments in Phase II or II/III and three drugs in Phase I or I/II development.