Cambridge Antibody Technology announced the early results from a Phase II clinical trial using CAT-152 (lerdelimumab; human anti-TGFBeta(2) monoclonal antibody) in patients undergoing surgery for glaucoma. CAT-152 has been designed to prevent excessive post-operative scarring which is the major reason why glaucoma surgery can fail to lower intraocular pressure in the long term.
The Phase II clinical trial studied 56 patients who were undergoing combined glaucoma and cataract surgery. Patients were randomized to receive either CAT-152 (36 patients) or matching placebo (20 patients) in a series of four subconjunctival injections which were given on the day of surgery (both immediately pre and post-operatively), the day after surgery and a week after surgery. The primary objective of the trial was to assess safety and tolerability of CAT-152 injection in this group of patients. A secondary objective was demonstration of efficacy of CAT-152.
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 of the eye.
Intraocular pressure (IOP) was successfully lowered by surgery in both patient groups. Three months after operation the achieved IOP was lower in patients receiving CAT-152 (mean value 14.7 mmHg) compared to those receiving placebo (mean value 15.5 mmHg). IOP of 22 mmHg or lower was achieved by 100 per cent of CAT-152 treated patients compared to 17 of 20 (85 per cent) of placebo treated patients. IOP of 18 mmHg or lower was achieved by 31 of 36 (86 per cent) of CAT-152 treated patients compared to 14 of 20 (70 per cent) of placebo treated patients.
Pharmacological intervention (5FU injection or topical IOP lowering medication) was used in 10 of 36 (28 per cent) of CAT-152 treated patients compared to 4 of 20 (20 per cent) of placebo treated patients. The differences between groups were not statistically significant.
The results of this trial have been accepted for presentation at the American Academy of Ophthalmology in New Orleans, November 2001 at which time six months follow up data will be available.