Table 1.
Summary Of Clinical Studies Evaluating Safety And Efficacy Of Recombinant Human Nerve Growth Factor (rhngf) Eye Drops
| Study | Design | Subjects | Study Groups | Treatment Regimen | Outcome Measures | Results |
|---|---|---|---|---|---|---|
| NGF0112 (Phase 1) NCT01744704 Ferrari et al 201420 |
RCT, double masked, dose ascending in Switzerland and UK | 74 healthy volunteers | 0.5–5 µg/mL NGF 20 µg/mL NGF 60–180 µg/mL NGF Vehicle (control) (1:1:1:1) |
One drop Up to 3 times/day for 1–5 days |
S (AEs) and PK | All doses were well tolerated Mild discomfort at highest dose No significant systemic effect |
| NGF0212 (Phase 1) NCT01756456 Bonini et al 201821 |
Multicenter, RCT, double-masked, vehicle-controlled in Europe |
18 with unilateral NK | 10 µg/mL rhNGF 20 µg/mL rhNGF Vehicle (1:1:1) |
One drop 6 times/day for 8 weeks; 48 or 56 weeks follow up period |
S, PK and E | Ocular pain (28%) No significant systemic effect Corneal Healing at week 4 in 25% (control), 42% (both doses) and at week 8 in 50% (control), 67% (10 µg) and 85% (20 µg). |
| NGF0212 (Phase 2) NCT01756456 Bonini et al 201833 |
Multicenter, RCT, double-masked, vehicle-controlled in Europe |
156 with unilateral NK | 10 µg/mL rhNGF 20 µg/mL rhNGF Vehicle (1:1:1) |
One drop 6 times/day for 8 weeks; 48 or 56 weeks follow up period |
S and E | Well tolerated, Mild transient AEs No significant systemic effect Corneal Healing at week 4 in 20% (control), 55% (10 µg) and 58% (20 µg). At week 8 in 43% (control), 75% (10 µg) and 74% (20 µg). 96% no recurrence |
| NGF0214 (Phase 2) NCT02227147 |
Multicenter, RCT, double-masked, parallel group study in US | 48 with uni- or bilateral NK | 20 µg/mL NGF (n= 24) Vehicle (n=24) (1:1) |
One drop 6 times/day for 8 weeks | S and E | Corneal healing in 65% of NGF group and 17% of control |
| NGF0213 (Phase 2a) NCT02101281 Sacchetti et al 201820 |
Single-center, open-label, two dose study in Austria | 40 with moderate to severe dry eye | 20µg/mL rhNGF 4µg/mL NGF |
One drop BID for 28 days |
S and E | Both doses were well tolerated, safe and effective in improving symptoms and signs of DED. |
| NGF0116 (Phase 2) NCT03035864 |
Single center RCT, double-masked, Parallel group study in Italy | 120 with post cataract and refractive surgery | 20µg/mL NGF Vehicle (2:1) |
One drop 6 times/day for 8 weeks |
S and E | Not available |
| NGF0216 (Phase 2) NCT03019627 |
Single center RCT, double-masked, Parallel group study in the US | 150 with dry eye disease | 20µg/mL NGF Vehicle (2:1) |
One drop 6 times/day for 8 weeks |
S and E | Not available |
Abbreviations: RCT, Randomized clinical trial; S, Safety; E, Efficacy; AEs, Adverse Events; PK, Pharmacokinetics.