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Anti-scarring agent well tolerated in glaucoma/cataract clinical trial
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MELBOURN, England — A drug to prevent postop scarring was found to be safe and well-tolerated in a small clinical trial in combined cataract and glaucoma surgery. Developers hope the drug will be useful in preventing excessive scarring after glaucoma surgery, a major factor in the failure of filtering operations.
The drug, CAT-152 (lerdelimumab; human anti-TGF-beta-2 monoclonal antibody), was evaluated in a phase 2 trial of 56 patients who underwent combined cataract and glaucoma surgery, said researchers with Cambridge Antibody Technology (NASDAQ: CATG), based here.
In the clinical trial, patients were randomized to receive either CAT-152 (36 patients) or placebo (20 patients) in a series of four subconjunctival injections given on the day of surgery (both immediately preop and postop), the day after surgery and 1 week after surgery.
CAT-152 was found to be safe and well tolerated in this trial with no serious drug-related adverse events and no severe injection site reactions reported. There was no evidence of increased inflammation in the anterior chamber, according to Cambridge researchers.
Intraocular pressure (IOP) was successfully lowered by surgery in both patient groups. The differences between groups were not statistically significant. Three months postop, the achieved IOP was slightly lower in patients receiving CAT-152 (mean 14.7 mm Hg) compared with those receiving placebo (mean 15.5 mm Hg). IOP of 22 mm Hg or lower was achieved by 100% of CAT-152 treated patients compared with 85% of placebo treated patients. IOP of 18 mm Hg or lower was achieved by 86% of CAT-152 treated patients.
"We will be following up these combined glaucoma and cataract surgery patients for up to 3 years postop. The next CAT-152 clinical trial — phase 2/3 — will be in simple glaucoma surgery, not combined with cataract surgery. We expect that trial to enroll around 350 patients in 6 European countries and to start in the fourth quarter of this year," said David Glover, MD, Cambridge's medical director.
CAT-152 is a fully human anti-TGF-beta-2 monoclonal antibody developed specifically to neutralize the cytokine TGF-beta-2, overactivity of which is thought to cause scarring in and around the eye.
Detailed results of this trial will be presented at the American Academy of Ophthalmology in New Orleans this November; results from a phase 1/2a trial were presented at the Association for Research in Vision and Ophthalmology earlier this year.