Lerdelimumab Prevents Excessive Postoperative Scarring.(Brief Article)

2001 DEC 19 - (NewsRx.com & NewsRx.net) -- Cambridge Antibody Technology (CAT) announced the 6-month follow-up results from a Phase II clinical trial using CAT-152 (lerdelimumab; human anti-TGF(beta)2 monoclonal antibody) in patients undergoing surgery for glaucoma and cataract.

CAT-152 has been designed to prevent excessive postoperative scarring which is the major reason why glaucoma surgery can fail to lower intraocular pressure in the long-term.

The trial results were presented by consultant ophthalmic surgeon Dr. David Broadway, at the 2001 American Academy of Ophthalmology meeting which was held in New Orleans, Louisiana.

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 postoperatively), 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 exploration of efficacy of CAT-152.

As previously reported in August 2001 (3-month data), 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. Six months after operation the achieved IOP was lower in patients receiving CAT-152 (mean value 14.5 mmHg) compared with those receiving placebo (mean value 16.7 mmHg). The proportion of patients achieving IOP below 22 mmHg was: CAT-152 100%, placebo 80% (p=0.013). At lower IOP thresholds a similar trend was seen (less than 18 mmHg: CAT-152 83%, placebo 65%; less than 15 mmHg: CAT-152 50%, placebo 30%). In the early postoperative period intervention with 5FU injection was used in 10 of 36 (28%) CAT-152 treated patients compared with 2 of 20 (10%) on placebo.

By six months after surgery resumption of long-term topical IOP lowering medication was needed in 3 of 36 (8%) CAT-152 treated patients compared with 3 of 20 (15%) on placebo. One of these three placebo patients subsequently underwent repeat trabeculectomy to control IOP.